Add the canine aging trial registry (37 records) / database with the trials table

README.md

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+---
+license: cc-by-4.0
+language:
+  - en
+pretty_name: Canine aging trial registry
+tags:
+  - dogs
+  - aging
+  - geroscience
+  - clinical-trials
+  - veterinary
+  - registry
+size_categories:
+  - n<1K
+configs:
+  - config_name: default
+    data_files: canine_trials.jsonl
+---
+
+# Canine aging trial registry
+
+A registry of interventional studies and longitudinal cohorts on aging in dogs: lifespan and
+healthspan trials (rapamycin, diet restriction, L-deprenyl, the Dog Aging Project's TRIAD),
+cognitive-aging and mobility trials in senior dogs, immunosenescence and organ-decline
+interventions, cancer-prevention trials in older dogs, lifetime cohorts (Dog Aging Project,
+Golden Retriever Lifetime Study), and company regulatory programs for lifespan-extension drugs
+(Loyal's STAY study of LOY-002, LOY-001, LOY-003).
+
+Veterinary trials are not registered on ClinicalTrials.gov and company programs are known
+only from announcements, so no such registry existed. Each record is typed (design, status,
+setting, intervention and class, comparator, dose regimen, duration, population, primary
+outcome, result as the source states it, organisation, registration ids, sources) and every
+field is backed by a verbatim quote from the cited source; a validator refuses records whose
+quotes cannot be found in the cited abstract, full text or page snapshot.
+
+## Files
+
+| File | Contents |
+|---|---|
+| `canine_trials.jsonl` | one record per study (schema in `schema.json`) |
+| `canine_trials.csv` | flat export of the main fields |
+| `schema.json` | JSON Schema 2020-12 |
+| `sources/web/*.txt`, `sources/web_index.json` | text snapshots of company and press pages quoted by `web` sources, with URL, date and hash |
+| `sources/europepmc/*.json` | abstracts of peer-reviewed sources outside the canine-aging-corpus |
+
+Quotes from `pmid` sources are checked against the
+[canine-aging-corpus](https://huggingface.co/datasets/w0lph/canine-aging-corpus) abstracts
+and full texts.
+
+## Provenance and caveats
+
+v0 (2026-10-01): candidates were screened from the corpus (trial-tagged records and
+trial-vocabulary searches) and drafted by model-assisted extraction in batches, plus
+hand-written company records; all quotes validated; no domain-expert review yet. Records of
+kind `regulatory_program` rest on company and press sources only and say so in `notes`.
+Disease-treatment trials framed around a disease rather than aging are out of scope.
+
+Source code, validator and contribution guide: https://github.com/w0lph/k9/tree/main/trials.
+The registry is served as `canine_trial_search` by the
+[dog-geroscience-mcp](https://huggingface.co/datasets/w0lph/dog-geroscience-mcp-data) server
+and as pages at https://w0lph.github.io/k9/trials/.
+
+## Licence
+
+Registry text CC BY 4.0. Quotes are short excerpts used for verification and attribution;
+the cited articles keep their own licences. Snapshots of company and press pages are kept
+for verification only.

canine_trials.csv

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+id,name,acronym,kind,status,setting,intervention,intervention_class,comparator,dose_regimen,duration,n,breed,age,primary_outcome,result,lead_organization,sponsor_or_funder,start_year,end_year,pmids,summary
+l-deprenyl-beagle-survival-1997,L-deprenyl 1 mg/kg daily versus placebo survival study in 82 paired beagles,,controlled_trial,completed,,L-deprenyl,drug,placebo,1 mg/kg L-deprenyl orally once daily,2 years and 10 weeks,82,beagle,2.8 to 16.4 years,Survivorship (survival to the conclusion of the study),"When survivorship for all dogs in the study was analyzed there was no significant difference between the L-deprenyl and placebo treated groups. In the subset of elderly dogs, dogs in the L-deprenyl group survived longer (p < 0.05) than dogs in the placebo group: twelve of 15 (80%) L-deprenyl dogs survived to the conclusion of the study, in contrast to only 7 of 18 (39%) of the dogs who received placebo (P=0.017).",,,,,9307048,"Eighty-two beagles aged 2.8 to 16.4 years were allotted to 41 pairs and given placebo or 1 mg/kg L-deprenyl orally once daily for 2 years and 10 weeks. Across all dogs there was no significant difference in survivorship between the groups. In a subset of elderly dogs aged 10 to 15 years at the start who received tablets for at least 6 months, L-deprenyl-treated dogs survived longer (p < 0.05), with 12 of 15 surviving to the end of the study versus 7 of 18 on placebo (P=0.017)."
+selegiline-cds-open-label-2001,Selegiline hydrochloride (Anipryl) in dogs with cognitive dysfunction syndrome: noncomparative open-label study,,single_arm_trial,completed,,"Selegiline hydrochloride (Anipryl), oral",drug,None (noncomparative open-label study),0.5 to 1.0 mg/kg orally once daily,60 days,641,,,Overall improvement and response by clinical sign on days 30 and 60; adverse events,"Response to selegiline treatment on days 30 and 60 were similar. On day 60, 77.2% of dogs showed an overall improvement; response to treatment by clinical sign ranged from 67.8% (activity or sleep/wake cycle) to 77.8% (disorientation and interaction with family members). Diarrhea (4.2%), anorexia (3.6%), and vomiting/salivation (3.4%) were noted most frequently. Results of this study indicate the majority of the dogs with CDS responded to treatment with Anipryl by day 30.",,,,,19753696,"In a single-arm open-label study, 641 dogs with clinical signs of canine cognitive dysfunction syndrome received oral selegiline hydrochloride at 0.5 to 1.0 mg/kg once daily for 60 days. Responses at days 30 and 60 were similar; on day 60, 77.2% of dogs showed overall improvement, with sign-specific response rates from 67.8% to 77.8%. Diarrhea (4.2%), anorexia (3.6%) and vomiting/salivation (3.4%) were the most frequent adverse events."
+n6-n3-fatty-acids-vitamin-e-immune-geriatric-beagles-2003,Dietary n-6:n-3 fatty acid ratio and vitamin E on immune response and T cell subpopulations of healthy geriatric Beagles,,controlled_trial,completed,,Foods with low (1.4:1) or high (40:1) n-6 to n-3 fatty acid ratios in combination with three concentrations of all rac-alpha-tocopheryl acetate,diet_or_supplement,Factorial comparison across the diet groups (no separate untreated control stated),"n-6 to n-3 fatty acid ratio 1.4:1 or 40:1; all rac-alpha-tocopheryl acetate low 17 mg/kg of food, medium 101 mg/kg, high 447 mg/kg; keyhole limpet hemocyanin inoculation at 13 and 15 weeks",17 weeks,32,Beagle,7- to 10-year old,"Immune functions and T cell subpopulations (percentages of CD8+ T cells, CD4+ to CD8+ ratio) and delayed-type hypersensitivity (DTH) skin test response","After 12 weeks, dogs consuming low concentrations of alpha-tocopheryl acetate had lower percentages of CD8+ T cells and higher CD4+ to CD8+ ratios than dogs on medium or high concentrations; dogs consuming low n-3 fatty acids with medium alpha-tocopheryl acetate had the largest DTH response. The authors conclude that an optimum amount of dietary alpha-tocopheryl acetate, regardless of the n-6 to n-3 ratio, stimulates the CD8+ T cell population, and that its effects on the DTH response are blunted by dietary n-3 fatty acids.",,,,,12828263,"Thirty-two healthy female Beagles aged 7 to 10 years were fed for 17 weeks foods combining a low (1.4:1) or high (40:1) n-6 to n-3 fatty acid ratio with low, medium or high alpha-tocopheryl acetate, and were inoculated with keyhole limpet hemocyanin at weeks 13 and 15, to determine effects on immune function and T cell subpopulations. Dogs on low vitamin E had lower CD8+ T cell percentages and higher CD4+:CD8+ ratios than dogs on medium or high vitamin E, and the largest DTH skin response occurred with low n-3 and medium vitamin E. The authors conclude an optimum vitamin E level stimulates CD8+ T cells regardless of fatty acid ratio, while n-3 fatty acids blunt its effect on DTH."
+beagle-antioxidant-cofactor-landmark-discrimination-2004,"Prior experience, antioxidants and mitochondrial cofactors in aged beagles (landmark discrimination)",,randomized_controlled_trial,completed,,Food providing higher levels of vitamin E (antioxidants and mitochondrial cofactors),diet_or_supplement,,,,,,aged dogs,Performance on landmark-discrimination tasks; serum vitamin E concentrations,providing higher levels of vitamin E in food resulted in higher serum vitamin E concentrations and improved performance on landmark-discrimination tasks in aged dogs. Factors other than vitamin E also contributed to the response but remain undefined.,,,,,15150725,"This study fed aged dogs food providing higher levels of vitamin E and tested them on landmark-discrimination tasks. Higher dietary vitamin E produced higher serum vitamin E concentrations and improved landmark-discrimination performance, although factors other than vitamin E also contributed to the response. The published abstract gives no sample size, dose, duration or comparator."
+ginseng-brewers-yeast-gerivet-geriatric-dogs-2007,Panax Ginseng with brewers' yeast (Gerivet) as a stimulant for geriatric dogs,,randomized_controlled_trial,completed,client_owned,Ginseng (Panax Ginseng) together with brewers' yeast (Saccharomyces cerevisae),diet_or_supplement,"Brewers' yeast only (control group, but not a true placebo); an external group was also used for comparison",,"8 weeks of treatment, with follow-up at 12 and 16 weeks",80,,,"Owner questionnaire and three visual analogue scales: seven primary (mental) outcome measures and secondary (physical) outcome measures, as change from baseline","Panax Ginseng plus yeast significantly improved all evaluated variables within the group. Four of the seven primary (mentally) outcome measures were significant when comparing the changes in the Ginseng group with the control group, and six of the seven were significant when compared to an external group. As the secondary (physical) outcome measures were significantly better in both the Ginseng and the control group compared to the external group, it indicates that brewers' yeast is the ingredient that has impact on physical performance. No significant changes in blood- or urine analyses and no side effects were seen.",,,,,17610402,"Eighty dogs were given either Panax Ginseng with brewers' yeast (n = 41) or brewers' yeast alone as a non-placebo control (n = 39) for 8 weeks, with blinded owners scoring a questionnaire and three visual analogue scales weekly and at 12 and 16 weeks of follow-up. Ginseng plus yeast improved all variables within its group; four of seven primary mental measures were significantly better than the control group and six of seven better than an external group. Physical measures improved in both treated groups relative to the external group, attributed to the yeast, and no side effects or blood or urine changes were seen."
+beagle-phosphatidylserine-ginkgo-nutraceutical-crossover-2008,"Nutraceutical supplement (phosphatidylserine, Ginkgo biloba, vitamin E, pyridoxine) for short-term memory in aged beagles",,crossover_trial,completed,,"Commercially available nutraceutical supplement containing phosphatidylserine, Ginkgo biloba, vitamin E, and pyridoxine",diet_or_supplement,Control substance,,,9,Beagle,aged,Performance accuracy on a delayed-non-matching-to-position task (short-term visuospatial memory),Performance accuracy was significantly improved in supplemented dogs compared with control dogs and the effect was long lasting.,,,,,18481547,"Nine aged beagles were tested on a delayed-non-matching-to-position task of short-term visuospatial memory, then given a commercial nutraceutical containing phosphatidylserine, Ginkgo biloba, vitamin E and pyridoxine or a control substance in a two-phase crossover design. Performance accuracy was significantly improved in supplemented dogs compared with controls, and the effect was long lasting. Dose and phase duration are not given in the abstract."
+same-cognitive-decline-rct-2008,S-adenosylmethionine (Novifit) for age-related mental decline in dogs: double-blinded placebo-controlled trial,,randomized_controlled_trial,completed,,"Oral S-adenosylmethionine (SAMe) tosylate tablets (Novifit tablets, Virbac)",diet_or_supplement,Identical placebo tablets,"18 mg/kg SAMe tosylate, oral tablets, for 2 months",2 months,36,,older than 8 years,"14-item standardized questionnaire evaluating behavior and locomotion difficulties (activity, awareness, aggregate mental impairment score)","Compared with the placebo group, SAMe-treated dogs showed greater improvement in activity (41.7% versus 2.6% after 4 weeks, P<.0003; 57.1% versus 9.0% after 8 weeks, P<.003) and awareness (33.3% versus 17.9% after 4 weeks, P<.05; 59.5% versus 21.4% after 8 weeks, P<.01). The aggregate mental impairment score was reduced by more than 50% in 41.2% and 15.8% of dogs treated with SAMe and placebo, respectively, at week 8. SAMe tosylate tablets proved safe and effective in improving signs of age-related mental decline in dogs.",,,,,18597245,"Thirty-six dogs older than 8 years with at least one month of cognitive dysfunction signs received 18 mg/kg oral SAMe tosylate (n=17) or identical placebo tablets (n=19) for 2 months, with behavior and locomotion scored on a 14-item questionnaire. SAMe-treated dogs improved more than placebo in activity and awareness at 4 and 8 weeks, and 41.2% versus 15.8% had their aggregate mental impairment score reduced by more than half at week 8. The authors conclude SAMe tosylate tablets were safe and effective for signs of age-related mental decline."
+beagle-antioxidant-diet-behavioral-enrichment,Antioxidant-fortified diet and behavioral enrichment in aged beagles (longitudinal study),,controlled_trial,completed,,"Antioxidant-fortified food (a broad spectrum of antioxidants and mitochondrial enzymatic cofactors) and a program of behavioral enrichment (increased exercise, environmental enrichment, and a series of learning tasks), alone and combined in a 2 x 2 factorial design",combination,Control food and control (normal level) environment,,"2-year longitudinal study; cognitive testing after 6 months, 1 year and 2 years of treatment",48,Beagle,9-12 years (aged groups),Discrimination and reversal learning (oddity discrimination after 6 months; size discrimination and reversal after 1 year; black/white discrimination after 2 years); neutrophil phagocytosis and lymphocyte proliferation in an immune sub-analysis,"At one and two years, the aged combined treatment group showed more accurate learning than the other aged groups. Discrimination learning was significantly improved by behavioral enrichment. Reversal learning was improved by both behavioral enrichment and dietary fortification. By contrast, the fortified food had no effect on the young dogs. In the immune sub-analysis, neutrophil phagocytosis was significantly increased in dogs receiving both dietary antioxidants and cognitive enrichment.",,,,,12392778;15130670;15585348;16806493;17717087;19714491,"A longitudinal controlled study in beagles tested an antioxidant-fortified food and a program of behavioral enrichment, alone and combined, against control food and a control environment in a 2 x 2 factorial design. Forty-eight aged dogs (9-12 years) were assigned from baseline cognitive scores into four cognitively equivalent groups of 12, with additional groups of young dogs. Discrimination and reversal learning were tested after 6 months, 1 year and 2 years of treatment; the combined-treatment group learned more accurately than the other aged groups at one and two years, enrichment improved discrimination learning, and both treatments improved reversal learning. An immune sub-analysis of 21 dogs found neutrophil phagocytosis significantly increased in dogs receiving both treatments."
+purina-lifetime-diet-restriction,Lifetime 25% diet restriction paired-feeding study in 48 Labrador Retrievers,,randomized_controlled_trial,completed,,"25% diet restriction (each restricted dog fed 75% of the food consumed by its control-fed pair mate; same diet, only the quantity differed)",diet_restriction,Control-fed (CF) pair mate,25% less food than the pair-mate (75% of the total food consumed by the control-fed pair mate); feeding began at age 8 weeks,From 8 weeks of age until death (lifetime); body composition measured annually until 12 years of age; immune parameters monitored from 4 to 13 years,48,Labrador Retriever,Paired at age 6 weeks; feeding protocol from 8 weeks of age until death,"Life span (median: age when 50% of dogs deceased; maximum: age when 90% deceased), age at onset of chronic disease, and markers of aging (serum biochemistry, body condition, body composition)","Median life span was significantly longer for dogs in which food was restricted (1.8 years longer median lifespan among diet-restricted dogs), and the onset of clinical signs of chronic disease generally was delayed, especially osteoarthritis. CR retarded age-related declines in lymphoproliferative responses and lymphocyte subsets. No differences in prevalence or severity of radiographic and histopathologic elbow OA were found between feeding groups; long-term DR did not negatively affect skeletal maturation, structure or metabolism.",,,,,11991408;18062831;16567002;19236677,"Forty-eight Labrador Retrievers from seven litters were paired by sex and weight, and one dog in each pair was randomly assigned to receive 25% less food than its control-fed pair mate from 8 weeks of age until death. Median life span was significantly longer in the diet-restricted dogs (1.8 years longer), and the onset of clinical signs of chronic disease, especially osteoarthritis, was delayed. Diet restriction also retarded age-related declines in lymphoproliferative responses and lymphocyte subsets and did not negatively affect skeletal maturation, while elbow osteoarthritis prevalence and severity did not differ between feeding groups."
+skn-cell-therapy-canine-cognitive-dysfunction-sydney-2022,Autologous skin-derived neural precursor (SKN) cell therapy for canine cognitive dysfunction in older companion dogs (DOGS + CELLS trial),DOGS + CELLS,single_arm_trial,completed,client_owned,Direct microinjection of autologous skin-derived neuroprecursors (SKNs) into the bilateral hippocampus using MRI-guided stereotaxis,cell_or_gene_therapy,"None (open-label, no control arm); post-mortem histology compared with a brain bank (N = 12) of untreated aged dogs","250,000 autologous SKNs microinjected into the bilateral hippocampus",3-month primary endpoint; clinical follow-up up to 2 years,6,,aged 10-16 years,Change in the Canine Cognitive Dysfunction Rating Scale (CCDR) from baseline to 3 months post treatment; safety assessed clinically,"Four out-of-five dogs improved on the primary clinical CCDR endpoint, three fell below diagnostic threshold, and two underwent full syndromal reversal lasting up to 2 years (modified ITT paired T test = 3.06, df = 4, p = 0.038). At post mortem, hippocampal synaptic density was nine standard deviations above non-treated dogs. There was no impact on AD pathology or long-term safety signals; one patient had a surgical adverse event requiring euthanasia.",University of Sydney,,2012,2020,35715872;35715872,"An open-label Phase 1/2A veterinary trial at the University of Sydney, run over 2012-2020, treated six older companion dogs (aged 10-16 years) with a definitive diagnosis of canine cognitive dysfunction by MRI-guided microinjection of 250,000 autologous skin-derived neural precursor cells into both hippocampi. The primary endpoint was change in the CCDR scale at 3 months. Four of five evaluable dogs improved, three fell below the diagnostic threshold and two showed full syndromal reversal lasting up to 2 years; one dog had a surgical adverse event requiring euthanasia, and post-mortem hippocampal synaptic density was far above untreated dogs."
+golden-retriever-lifetime-study,Golden Retriever Lifetime Study (Morris Animal Foundation),GRLS,longitudinal_cohort,ongoing,client_owned,,none,,,lifetime follow-up; baseline enrolment June 2012 to April 2015,3044,Golden Retriever,6 months to 2 years at enrolment,"incidence of hemangiosarcoma, lymphoma, osteosarcoma and high-grade mast cell tumors; secondary outcomes include other cancers, hypothyroidism, epilepsy, atopy, otitis externa, hip dysplasia, heart failure and renal failure",,Morris Animal Foundation,Morris Animal Foundation,2012,,35679242,"The Golden Retriever Lifetime Study is a prospective cohort of 3,044 US Golden Retrievers enrolled between 2012 and 2015 at 6 months to 2 years of age, followed for life with annual owner and veterinarian questionnaires, examinations and biobanked samples. Its primary outcomes are four cancers; secondary outcomes include other cancers and common age-related diseases. Questionnaire data are available to approved researchers under a data use agreement."
+mct-fish-oil-carnitine-beagles-serum-aging-2012,"Medium-chain triglyceride, fish oil and L-carnitine enriched foods against age-associated serum fatty acid and carnitine changes in healthy Beagles",,randomized_controlled_trial,completed,laboratory_colony,"Foods enriched with medium-chain triglycerides (MCT), fish oil and L-carnitine (two treatment foods)",diet_or_supplement,Control food,"Treatment diets contained added L-carnitine (300 mg/kg) and 0.6% (treatment food 1) or 1.5% (treatment food 2) added fish oil; treatment food 2 also had increased MCT from coconut oil, added corn oil and reduced animal fat",6 months,41,Beagle,mean age 9.9 years (range 3.1 to 14.8),Serum fatty acid composition (gas chromatography) and serum carnitine metabolites (metabolomic profiling); body composition by dual energy x-ray absorptiometry,"Serum concentrations of carnitine metabolites were decreased in geriatric (>7 years) vs. mature adult (<= 7 years) dogs, and supplementation with L-carnitine attenuated the effects of aging; serum eicosapentaenoic and docosahexaenoic FA increased in a dose-dependent manner; no change in total-lean-body weight, serum total protein or albumin by time or dietary treatment. The authors summarise that dietary MCT, fish oil, and L-carnitine counterbalanced the effects of aging on circulating concentrations of these compounds.","Hill's Pet Nutrition, Inc., Topeka, KS, USA",,,,23145181;23145181,"Forty-one healthy Beagles (mean age 9.9 years, range 3.1 to 14.8) housed at a Hill's colony were randomized to a control food or one of two foods enriched with L-carnitine and fish oil, the second also containing medium-chain triglycerides, for 6 months. The stated purpose was to test whether these foods offset age-associated changes in serum fatty acids and carnitine metabolites. Carnitine metabolites were lower in geriatric than mature dogs and L-carnitine supplementation attenuated this, while serum EPA and DHA rose dose-dependently; the authors conclude the diet counterbalanced the effects of aging on these circulating compounds."
+astaxanthin-mitochondrial-function-beagles-2013,Dietary astaxanthin and age-associated mitochondrial dysfunction in young and geriatric Beagles,,controlled_trial,completed,,Astaxanthin fed daily,diet_or_supplement,0 mg astaxanthin,0 or 20 mg astaxanthin daily for 16 wk,"16 wk (blood sampled wk 0, 8 and 16)",28,Beagle,young (2.97±0.01 yr) and geriatric (10.71±0.01 yr),"Leukocyte mitochondrial function (membrane permeability, ATP production, cytochrome c oxidase/reductase, mitochondrial number) and plasma oxidative stress markers","Mitochondrial function improved in both young and geriatric dogs by increasing (P<0.05) ATP production, mitochondria mass, and cytochrome c oxidoreductase activity, especially in geriatric dogs compared with young dogs; astaxanthin also increased the reduced to oxidized glutathione ratio in young dogs and decreased nitric oxide in both age groups. Dietary astaxanthin improved mitochondrial function in blood leukocytes, most likely by alleviating oxidative damage to cellular DNA and protein.",,,,,23100599,"Healthy female Beagles in a young (about 3 years) and a geriatric (about 10.7 years) group, 14 per age group, were fed 0 or 20 mg astaxanthin daily for 16 weeks to examine modulation of age-associated mitochondrial dysfunction. Leukocyte mitochondrial function and plasma oxidative markers were measured at weeks 0, 8 and 16. Astaxanthin increased ATP production, mitochondrial mass and cytochrome c oxidoreductase activity, especially in geriatric dogs, and lowered nitric oxide in both age groups."
+mannac-place-learning-crossover-2014,N-acetyl-D-mannosamine (ManNAc) for age-related decline in place learning in dogs,,crossover_trial,completed,,"N-acetyl-D-mannosamine (ManNAc), oral capsule",drug,"Glucose capsule (control, equivalent calorie value)",One capsule containing 250 mg ManNAc or glucose orally once a day for 2 months,2-month courses of each treatment in a crossover design with a 1-month washout period,5,Labrador Retriever,93.60 ± 11.98 months,Number of error trials in a place-learning test; active-resting cycle (daytime/nighttime motor activity ratio),"ManNAc treatment significantly reduced the number of error trials in the place-learning test, especially in the first month of administration. Three ManNAc-treated dogs also showed improvement in the active-resting cycle. In conclusion, ManNAc treatment appears to alleviate age-related cognitive dysfunction.",,,,,24430654;24430654,"Five older Labrador Retrievers (93.60 ± 11.98 months) with low cognitive levels, living at a guide dog facility, received 2-month courses of 250 mg oral ManNAc and of glucose control in a crossover design with a 1-month washout. ManNAc significantly reduced place-learning error trials, especially in the first month, and three dogs improved in their active-resting cycle. Because the sample was 4 or 5 dogs, significance was set at 10%."
+hills-functional-foods-renal-function-geriatric-colony-2016,Renal protective foods with functional food bioactives against age-associated decline in renal function (Hill's geriatric Beagle colony),,randomized_controlled_trial,completed,laboratory_colony,"Control renal protective food supplemented with increasing amounts of functional food bioactives (fish oil, lipoic acid, fruits and vegetables, higher quality protein sources): functional foods FF1 and FF2",diet_or_supplement,Traditional renal protective food (control; energy dense and mildly protein-restricted; Hill's Science Diet Mature Adult),"Both functional foods contained 0.5% fish oil and 100 mg/kg lipoic acid; FF1 contained 2.75% fruits and vegetables, 7% egg protein and 7.5% wet meat chicken; FF2 contained 7.5% fruits and vegetables, 14% egg protein, 10% wet meat chicken and 955 IU/kg a-tocopherol acetate",6 months,111,Beagle,"geriatric: mean age 10.4, range 7.9-14.2 years; mature adult: mean age 5.0, range 3.3-6.9 years","Glomerular filtration rate (GFR), lean body percent (LB%) by dual energy x-ray absorptiometry, and circulating biomarkers and metabolites including symmetric dimethylarginine (SDMA)","Geriatric dogs consuming all three foods increased (P<0.001) GFR over time; group averages ranged from 13.0-16.9%. Dogs fed the highest supplemented level of bioactives (FF2) had lower (P<0.001) SDMA concentrations (-14.3%). Feeding functional foods did not alter body weight, but increased (P<0.001) serum protein concentration (+6.7%). The authors conclude that supplementation with functional food bioactives can temporarily reverse the age-associated decline in renal function and serum total protein.","Pet Nutrition Center, Hill's Pet Nutrition, Inc., Topeka, KS","Hill's Pet Nutrition, Inc.",,,27925141;27925141,"Eighty-one healthy geriatric Beagles (mean 10.4 years) at the Hill's Pet Nutrition colony were randomly assigned, after blocking for sex, to a control renal protective food or to one of two functional foods (FF1, FF2) with increasing amounts of fish oil, lipoic acid, fruits and vegetables and higher quality protein, for 6 months; 30 mature adult dogs served as a cross-sectional comparison. GFR, lean body percent and circulating biomarkers were measured. GFR increased over time in all three geriatric groups, FF2 lowered SDMA by 14.3%, and serum protein rose; the authors conclude functional food bioactives can temporarily reverse the age-associated decline in renal function."
+hills-test-food-sdma-client-owned-geriatric-dogs-2016,Test food designed to promote healthy aging vs owner's-choice foods on serum SDMA and creatinine in client-owned geriatric dogs,,randomized_controlled_trial,completed,client_owned,"Test food (renal protective food) containing functional lipids (fish oil), antioxidants (lipoic acid, vitamins C and E), L-carnitine, botanicals (fruits and vegetables), controlled sodium concentration and high quality protein sources",diet_or_supplement,Owner's-choice foods (non-nutritionally controlled cohort),,"6 months (biomarkers evaluated at baseline, 3 and 6 months)",210,,"small (6.8 to 11.4 kg) and medium dogs (11.5 to 22.7 kg) were >= 9 years, dogs >22.7 kg were >= 7 years at baseline; enrolled dogs had mean age 9.7 years (range 7 to 15 years)","Serum symmetric dimethylarginine (SDMA) and creatinine (Cr) concentrations, plus urinalysis, at baseline, 3 and 6 months","Only dogs consuming test food showed significant decreases in serum SDMA and Cr concentrations (both P <= 0.05) across time. Among 18 dogs with increased SDMA but normal Cr (consistent with IRIS Stage 1 CKD), the decreases in serum SDMA and Cr were significant (both P = 0.03) only for dogs fed test food.","Hill's Pet Nutrition, Inc., Topeka, KS (protocol approval and test food); contract research organization with seventeen US veterinary clinics",,,,27088214;27088214,"A prospective 6-month feeding study in client-owned geriatric dogs recruited through seventeen US veterinary clinics randomized dogs to a Hill's test food designed to promote healthy aging (fish oil, lipoic acid, vitamins C and E, L-carnitine, fruits and vegetables, controlled sodium, high quality protein) or to owner's-choice foods; 255 dogs were enrolled and 210 are reported in the abstract. Serum SDMA and creatinine were measured at baseline, 3 and 6 months. Only dogs fed the test food showed significant decreases in SDMA and creatinine across time, including among the 18 dogs with elevated SDMA consistent with IRIS Stage 1 CKD."
+beagle-abeta-vaccination-behavioral-enrichment,Aβ vaccination combined with behavioral enrichment in aged beagles,,controlled_trial,completed,laboratory_colony,"Active vaccine against fibrillar Aβ 1-42 (VAC) and behavioral enrichment (ENR), alone and combined",combination,Control/control group: alum-only injections without behavioral enrichment,"0.5 mg fibrillar Aβ with 2% aluminum hydroxide (alum) injected subcutaneously, boosted after 2 weeks and then monthly; control animals received alum injections. Enrichment: two 20-min outdoor group walks weekly, weekly rotation of play toys, and cognitive enrichment tasks",20 months,34,Beagle,11-12 years (abstract); 10.5-13.6 years at study start (full text),"Cognition (learning and memory), brain Aβ and pyroglutamate Aβ, cerebrospinal fluid Aβ42, brain-derived neurotrophic factor mRNA, and microhemorrhages","VAC decreased brain Aβ, pyroglutamate Aβ, increased cerebrospinal fluid Aβ 42 and brain-derived neurotrophic factor RNA levels but also increased microhemorrhages. ENR reduced brain Aβ and prevented microhemorrhages. The combination treatment resulted in a significant maintenance of learning over time, reduced Aβ, and increased brain-derived neurotrophic factor mRNA despite increased microhemorrhages; however, there were no benefits to memory.",,,,,27776266;27776266,"Thirty-four aged beagles (11-12 years) were assigned, balancing baseline cognitive scores, sex and age, to control, active fibrillar Aβ 1-42 vaccine, behavioral enrichment, or vaccine plus enrichment groups and treated for 20 months. The vaccine (0.5 mg fibrillar Aβ with alum, subcutaneous, boosted at 2 weeks then monthly) reduced brain Aβ and raised CSF Aβ42 and BDNF RNA but increased microhemorrhages, while enrichment reduced brain Aβ and prevented microhemorrhages. The combination produced significant maintenance of learning over time with reduced Aβ and increased BDNF mRNA, but no benefit to memory."
+labrador-inflammaging-cohort-2018,"Longitudinal analysis of inflammation, immune function and oxidative stress markers in 80 Labrador retrievers from adulthood to end of life",,longitudinal_cohort,completed,,,none,,,From adulthood to the end of life,80,Labrador retriever,From adulthood to the end of life,"Changes with age in markers of inflammation (immunoglobulin M, immunoglobulin G, C-reactive protein), oxidative stress (8-hydroxy-2-deoxyguanosine) and the heat shock protein 70 response to heat stress","Serum levels of immunoglobulin M (p < .001) and 8-hydroxy-2-deoxyguanosine (p < .001) increased with age, whereas no effect of age was detected for immunoglobulin G or C-reactive protein unless the last year of life was included in the analysis (p = .002). Baseline levels of heat shock protein 70 decreased with age (p < .001) while those after exposure to heat stress were maintained (p = .018); when excluding final year of life data, a decline in the heat shock protein 70 response after heat stress was observed (p = .004).",,,,,29126143,"Markers of inflammation, immune function and oxidative stress were measured longitudinally in 80 Labrador retrievers from adulthood to the end of life to determine whether dogs undergo inflammaging-like changes. Serum immunoglobulin M and 8-hydroxy-2-deoxyguanosine increased with age, immunoglobulin G and C-reactive protein changed only when the last year of life was included, and baseline heat shock protein 70 declined with age. The authors conclude that aging dogs undergo changes similar to human inflammaging, opening the possibility of nutritional or pharmacological intervention."
+antioxidant-omega3-enriched-diet-telomere-mobility-shepherd-dogs-2020,"Diet enriched with antioxidants, mitochondrial cofactors and omega-3 fatty acids on telomere length and joint mobility in young and old shepherd dogs",,randomized_controlled_trial,completed,,"Diet enriched with antioxidants, mitochondrial cofactors and omega-3 fatty acids",diet_or_supplement,Control diet,,"6 months (measurements at the outset, after 3 and after 6 months)",74,shepherd dogs,young and old (ages not stated in the abstract),"Mean and minimum telomere lengths; minimum and maximum joint angles and range of motion of the shoulder, elbow, carpal, hip, stifle and tarsal joints by computer-assisted gait analysis","A positive influence of the enriched diet on old dogs could be verified for minimum telomere length and all three parameters of the shoulder joint on the side with the higher vertical ground reaction force after 6 months. In the other joints there were less significant differences; in some cases they indicated a contrary influence of the enriched diet on young dogs, probably due to its reduced protein content.",,,,,32000015,"A randomized, blinded, placebo-controlled study fed 36 young and 38 old shepherd dogs either a diet enriched with antioxidants, mitochondrial cofactors and omega-3 fatty acids or a control diet, on the premise that aging-related oxidative stress could be counteracted by such a diet. Telomere length and joint kinematics from computer-assisted gait analysis were measured at the outset and after 3 and 6 months. In old dogs the enriched diet had a positive effect on minimum telomere length and on shoulder joint mobility after 6 months, with smaller or contrary effects in other joints and in young dogs."
+triad-rapamycin,Test of Rapamycin in Aging Dogs (TRIAD),TRIAD,randomized_controlled_trial,ongoing,client_owned,Rapamycin (weekly low-dose),drug,placebo,Weekly low-dose rapamycin; the rapamycin treatment group receives a cumulative dose of 0.15 mg/kg administered once weekly (as described in the 2023 Texas A&M trial report),One-year course of weekly rapamycin; lifespan and healthspan endpoints,,,"Healthy, middle-aged dogs","Lifespan, plus healthspan metrics (heart and cognitive function, age-related disease incidence)",,Dog Aging Project (multicenter; seven US veterinary teaching hospitals),,2021,,39951177;35110758;37275618,"TRIAD is a parallel-group, double-masked, randomized, placebo-controlled, multicenter trial that will test whether rapamycin prolongs lifespan and improves healthspan metrics in healthy, middle-aged, large-breed dogs recruited from Dog Aging Project participants. The hypothesis is that a one-year course of weekly low-dose rapamycin (0.15 mg/kg once weekly) can increase lifespan, improve heart and cognitive function and reduce age-related disease incidence. Enrolment began in June 2021, dogs are seen every six months at one of seven US veterinary teaching hospitals, and no results have been reported."
+ashwagandha-geriatric-labradors-rct-2024,Ashwagandha (Withania somnifera) root extract on aging-related changes in healthy geriatric client-owned dogs,,randomized_controlled_trial,completed,client_owned,Withania somnifera/ashwagandha root extract (ARE),diet_or_supplement,Placebo control,"15 mg/kg, once daily, orally","60 days (assessed at initiation, day 30 and day 60); conducted July 2022 to September 2022",20,Labrador,aged 8 years or older,"Serum cortisol, haematological profile, biochemical markers (liver and kidney function), antioxidant indicators and anti-inflammatory responses","Erythrocyte count and haemoglobin were significantly increased with ARE (p < 0.001) and leukocyte count decreased (p < 0.05); liver function markers (ALT, AST, albumin, globulin; p < 0.001 at day 60) and kidney function markers (creatinine, BUN; p < 0.001 at days 30 and 60) decreased in ARE-treated dogs compared to placebo; oxidative stress markers were significantly modulated; serum cortisol reduced significantly (p < 0.001); and key inflammatory markers (IFN-gamma, TNF-alpha, NF-kB, IL-10) decreased from baseline (p < 0.001) at day 60. The authors conclude ARE has adaptogenic properties in healthy geriatric dogs.","College of Veterinary Science, P.V.N.R. Telangana Veterinary University, Hyderabad (ethics approval); conducted at Cure Pet Clinic, Hanamkonda, Telangana, India",None stated (funding information: None),2022,2022,39078383;39078383,"A randomized, double-blind, placebo-controlled trial at a pet clinic in Telangana, India (July to September 2022) enrolled 20 apparently healthy, obese, client-owned geriatric Labradors aged 8 years or older and gave 10 of them ashwagandha root extract at 15 mg/kg orally once daily and 10 a placebo, to test whether ARE mitigates age-related changes. Haematology, liver and kidney markers, oxidative stress, cortisol and inflammatory markers were measured at baseline, day 30 and day 60. ARE raised erythrocyte count and haemoglobin, lowered liver and kidney markers relative to placebo, reduced cortisol and lowered inflammatory cytokines from baseline at day 60."
+fortetropin-senior-dogs-mobility-rct-2022,Fortetropin in geriatric and senior dogs with reduced mobility,,randomized_controlled_trial,completed,,"Fortetropin, a nonthermal-pasteurized, freeze-dried, fertilized egg yolk product",diet_or_supplement,Placebo,,12 weeks (mobility scores at week 6 and week 12),,,senior dogs,Mobility scores from the Liverpool Osteoarthritis in Dogs (LOAD) questionnaire,"Mild, but statistically significant, improvement of the mobility scores for the treatment group at both week 6 (P = 0.03) and week 12 (P = 0.006) compared to the baseline score. No statistical improvement was noted at any time in the placebo group or between the treatment and placebo group.",,,,,36185794,"A randomized, double-blinded, placebo-controlled study evaluated Fortetropin, a freeze-dried fertilized egg yolk product, on mobility in senior dogs, motivated by age-related muscle atrophy and osteoarthritis pain. Mobility was scored with the owner-completed LOAD questionnaire. The treatment group showed mild but statistically significant improvement from baseline at weeks 6 and 12, whereas the placebo group did not improve and there was no significant difference between treatment and placebo groups."
+ly-d6-2-senolytic-nad-precursor-senior-dogs-rct-2024,LY-D6/2 senolytic and NAD+ precursor combination in senior companion dogs with mild to moderate cognitive impairment,LY-D6/2,randomized_controlled_trial,completed,client_owned,"LY-D6/2, a proprietary combination of a senolytic (LY-D6) and an NAD+ precursor (LY-D2), given at low or full dose",diet_or_supplement,Placebo,NAD+ precursor (or placebo) capsule(s) once daily and the senolytic (or placebo) capsule(s) on two consecutive days each month; low or full dose (amounts not disclosed),"6 months (3-month primary endpoint, 6-month secondary endpoint)",70,,10 years or older,Change in owner-reported Canine Cognitive Dysfunction Rating (CCDR) scale score and change in activity measured with collar-mounted physical activity monitors at 3 months,"There was a significant difference in CCDR score across treatment groups from baseline to the primary endpoint (p = 0.02) with the largest decrease in the full dose group. No difference was detected between groups using in house cognitive testing, and no significant differences between groups in changes in measured activity. The proportion of dogs that improved in frailty and owner-reported activity and happiness was higher in the full dose group but not significantly; adverse events occurred equally across groups. The authors conclude that LY-D6/2 improves owner-assessed cognitive function over a 3-month period.",North Carolina State University College of Veterinary Medicine,"Animal Bioscience, Boston MA",2022,,38811634;38811634,"A blinded, three-arm randomized controlled trial at North Carolina State University enrolled 70 companion dogs aged 10 years or older with mild to moderate cognitive impairment and allocated them to placebo, low-dose or full-dose LY-D6/2, a proprietary senolytic plus NAD+ precursor combination given as a daily NAD+ precursor and a monthly two-day senolytic course, for 6 months. Primary outcomes were owner-rated CCDR score and activity-monitor data at 3 months. CCDR change differed significantly across groups (p = 0.02) with the largest improvement on the full dose, while activity, in-house cognitive tests, frailty and owner-reported happiness did not differ significantly; the trial was funded by Animal Bioscience."
+cow-placenta-extract-cognition-aged-dogs-rct-2026,Cow placenta extract (CPE) on cognitive function and oxidative stress in aged client-owned dogs,,randomized_controlled_trial,completed,client_owned,Cow placenta extract (CPE) oral capsules,diet_or_supplement,"Placebo capsules identical in appearance, same dosage, method and duration","200 mg CPE orally for dogs weighing 5-15 kg and 400 mg for dogs over 15 kg, twice daily for 6 months","6 months (CSLB at months 2, 4 and 6)",88,,aged dogs >= 7 years per the abstract; over 8 years of age per the full-text inclusion criteria,"Canine Social and Learning Behavior Survey (CSLB) score; serum oxidative stress markers (MDA, GSH-Px, GSH and others)","By month 6, mean CSLB was 35.1 +/- 4.9 in the CPE group vs 41.1 +/- 5.3 in the placebo group (P < .05; Cohen's d = -1.17). The successful therapeutic response was 77.8% in the CPE group vs 9.3% in the placebo group (P < .001). Change in CSLB correlated positively with change in MDA (r = 0.77) and negatively with change in GSH-Px and GSH. The authors conclude a six-month CPE administration improved cognitive function and oxidative stress in aged dogs.","Jiangsu Agri-animal Husbandry Vocational College, China (ethics committee); 3 animal clinics in the eastern region of China",,2023,2024,42492061;42492061,"A 6-month randomized, blinded, placebo-controlled trial in eastern China enrolled client-owned aged dogs (over 7-8 years, more than 5 kg) with a CSLB cognitive score of 30 or more from three animal clinics; 88 dogs completed the trial (45 CPE, 43 placebo). Dogs received cow placenta extract capsules (200 mg for 5-15 kg, 400 mg over 15 kg) or identical placebo twice daily, with CSLB questionnaires and serum oxidative stress markers as outcomes. At month 6 the CPE group had a lower mean CSLB score (35.1 vs 41.1) and a 77.8% response rate versus 9.3% for placebo, and CSLB change correlated with changes in MDA, GSH-Px and GSH."
+dog-aging-project,Dog Aging Project (DAP) long-term longitudinal study of ageing in companion dogs,DAP,longitudinal_cohort,ongoing,client_owned,,none,,,"Long-term; data and biospecimens collected annually, with dogs enrolled for the dog's lifetime",30000,All breeds (both purebred and mixed breed),All ages,"Identify the genetic, environmental and lifestyle factors associated with healthy lifespan; characterize ageing on multimorbidity, frailty and inflammageing; whole-genome sequencing of at least 10,000 dogs; metabolome, epigenome and microbiome biomarkers of ageing",,,"National Institute on Aging (NIA U19 AG057377), as cited in the funding statement of the 2023 Texas A&M rapamycin trial",,,35110758;35110758;37275618,"The Dog Aging Project is a long-term, open-data longitudinal study of ageing in tens of thousands of privately owned companion dogs of all breeds, ages, sizes and sexes across the USA, with over 30,000 participants at the time of the 2022 design paper. It collects survey, environmental, veterinary-record, genome-sequence, clinicopathology and molecular data annually for the dog's lifetime, aiming to identify genetic, environmental and lifestyle factors associated with healthy lifespan and to characterize multimorbidity, frailty and inflammageing. The project comprises five overlapping cohorts, including the TRIAD rapamycin trial and the Precision cohort, which are recorded separately; no results are reported in the design paper."
+old-dog-padua-cohort,OLD-DOG Project: 30-month prospective biomarkers-of-aging cohort of 209 companion dogs (University of Padua),OLD-DOG,longitudinal_cohort,ongoing,client_owned,,none,,,30-month prospective study with comprehensive evaluations every six months,209,Multi-breed cohort,Aged 5 years and over (dogs aged over five years with at least the month of birth known),"Identification and validation of biomarkers of aging (physiological, biochemical, hematological and behavioral parameters, microbiota profiles, telomere length, DNA methylation) and their predictive value for healthspan and lifespan","Preliminary cross-sectional analyses have identified consistent age-related patterns across multiple domains, including hematological and biochemical indices, inflammatory markers, and measures of physical and cognitive performance. The frailty index showed a moderate correlation with chronological age (ρ=0.56, p < .0001); of the 206 dogs for which survival status was available, 29 had died by the fourth time point. Longitudinal analyses are ongoing.",University of Padua's Veterinary Teaching Hospital,"Italian Ministry of University and Research (MUR), PRIN grant 20228NKPNH",2023,,41860870;41860870,"The OLD-DOG Project, launched in 2023 at the University of Padua's Veterinary Teaching Hospital, is a 30-month prospective observational study of 209 privately owned, multi-breed dogs aged 5 years and over from the Veneto region of Italy, evaluated every six months with clinical examinations, physical fitness testing, blood and fecal sampling and owner questionnaires. Its purpose is to identify and validate biomarkers of aging and assess their predictive value for healthspan and lifespan. Preliminary cross-sectional analyses show consistent age-related patterns in hematological and biochemical indices, inflammatory markers and physical and cognitive performance, the frailty index correlates moderately with age, and 29 of 206 dogs had died by the fourth time point; longitudinal analyses are ongoing."
+rapamycin-10-week-rct-2017,Short-term (10-week) rapamycin randomized controlled trial in 24 middle-aged companion dogs,,randomized_controlled_trial,completed,client_owned,Rapamycin at a non-immunosuppressive dose,drug,placebo,0.05 mg/kg three times weekly in one rapamycin treatment group and 0.1 mg/kg three times weekly in another rapamycin treatment group (as described in the 2023 Texas A&M follow-up trial); the 2017 abstract states only a non-immunosuppressive dose for 10 weeks,10 weeks,24,,Middle-aged; mean age of 9.7 years (as reported in the 2023 follow-up trial),"Safety of low-dose rapamycin (clinical and hematological exams before, during and after the trial) and echocardiographic measures of heart function before and after the trial","No clinical side effects in the rapamycin-treated group compared to dogs receiving the placebo. Echocardiography suggested improvement in both diastolic and systolic age-related measures of heart function (E/A ratio, fractional shortening, and ejection fraction) in the rapamycin-treated dogs. Hematological values remained within the normal range for all parameters studied; however, the mean corpuscular volume (MCV) was decreased in rapamycin-treated dogs.",,,,,28374166;37275618,"Twenty-four middle-aged healthy pet dogs received placebo or a non-immunosuppressive dose of rapamycin for 10 weeks in a randomized controlled trial whose primary goal was establishing safety, with echocardiography before and after treatment. No clinical side effects were seen in the rapamycin group, and echocardiography suggested improvement in diastolic and systolic age-related measures of heart function (E/A ratio, fractional shortening, ejection fraction). Hematology stayed within normal ranges apart from a decreased mean corpuscular volume in treated dogs. A companion pharmacokinetic study in 5 healthy purpose-bred hounds showed that oral low-dose (0.1 mg/kg) rapamycin achieved blood concentrations measurable in nanograms per milliliter."
+rapamycin-6-month-rct-tamu-2023,Six-month low-dose rapamycin masked placebo-controlled randomized trial in 17 healthy client-owned dogs (Texas A&M),,randomized_controlled_trial,completed,client_owned,Low-dose rapamycin,drug,Placebo (lactose capsules identical in appearance),"0.025 mg/kg rapamycin per dose, orally in capsules, three times per week (Monday, Wednesday and Friday mornings), rounded to the nearest 0.25 mg capsule","6 months of treatment; evaluations at baseline, 3, 6 and 12 months (final examination 6 months after discontinuation)",17,,6-10 years (mean 7.8 years in the rapamycin group and 8.5 years in the placebo group),"Echocardiographic indices of diastolic and systolic cardiac function at 6 and 12 months, and occurrence of adverse events; impact on routine clinical pathology was a secondary objective","There were no statistically significant differences in echocardiographic parameters between rapamycin and placebo groups at 6 or 12 months. No clinically significant adverse events occurred. In 26.8% of the bi-weekly surveys owners whose dogs received rapamycin reported perceived positive changes in behavior or health, compared to 8.1% in the placebo group (p = 0.04). The drug was well-tolerated with no significant adverse events.",Texas A&M University (TAMU) Veterinary Medical Teaching Hospital (VMTH),William H. Donner Foundation; additional support for some authors from the Dog Aging Project (NIA U19 AG057377),,,37275618;37275618,"Seventeen healthy client-owned dogs aged 6-10 years and weighing 18-36 kg were randomized at the Texas A&M veterinary teaching hospital to low-dose rapamycin (0.025 mg/kg three times per week) or identical placebo capsules for 6 months, with echocardiography and clinical pathology at baseline, 6 and 12 months. There were no statistically significant differences in echocardiographic parameters between groups at 6 or 12 months and no clinically significant adverse events. Owners of rapamycin-treated dogs reported perceived positive changes in behavior or health in 26.8% of bi-weekly surveys versus 8.1% for placebo (p = 0.04). Enrollment stopped early at 17 of a planned 50 dogs."
+ashwagandha-gut-parameters-geriatric-beagles-rct-2024,Ashwagandha root extract on gut parameters in healthy geriatric research Beagles,,randomized_controlled_trial,completed,laboratory_colony,Withania somnifera/Ashwagandha root extract (ARE; KSM-66) capsules,diet_or_supplement,Placebo (starch-filled capsules identical in appearance),"15 mg/kg body weight, once daily, orally, for 2 months","2 months (assessed on day 0, day 30 and day 60)",12,Beagle,12-15 years,"Serum haematology, biochemical markers, stool parameters (faecal score and pH) and gut-microbiome parameters (faecal short chain fatty acids, L-citrulline, intestinal-type alkaline phosphatase, lactate, carbamoyl-phosphate synthase)","Erythrocyte counts and haemoglobin were significantly increased with ARE; serum ALT and AST significantly decreased at day 60 compared with placebo; L-citrulline was significantly modulated while I-ALP, lactate and CPS were unaffected; faecal score reduced significantly (p < 0.001) while faecal pH was unaltered; propionic acid and total SCFAs decreased from baseline after 60 days while butyrate and acetic acid were unchanged. The authors suggest ARE has gut health promoting benefits in healthy geriatric dogs, reducing age-related changes by modulating the microbiome and its metabolites.",,"KSM-66 ashwagandha root extract and corn starch placebo provided as gift samples by Ixoreal BioMed, Inc., Los Angeles, CA (no other funding stated)",,,39911483;39911483,"A randomized, double-blind, placebo-controlled trial in Telangana, India randomly divided 12 healthy geriatric research Beagles aged 12-15 years, housed at a certified kennel, into ARE (KSM-66 ashwagandha root extract, 15 mg/kg orally once daily for 2 months; n = 6) and starch placebo (n = 6) groups, hypothesising that ARE would improve vital parameters for healthy ageing through the gut. Haematology, biochemistry, stool parameters and faecal metabolites were assessed on days 0, 30 and 60. ARE increased erythrocytes and haemoglobin, lowered ALT and AST at day 60 versus placebo, reduced faecal score, modulated L-citrulline and lowered propionic acid and total SCFAs from baseline."
+beagle-middle-aged-enrichment-tacrolimus-q134r-brain-atrophy,Behavioral enrichment with tacrolimus or Q134R in middle-aged beagles: longitudinal MRI brain atrophy study,,longitudinal_cohort,completed,,"Chronic treatment with the calcineurin inhibitor tacrolimus or the NFAT-inhibiting compound Q134R, in dogs undergoing behavioral enrichment",combination,,,,43,Beagle,middle-aged,"Age-related brain atrophy on annual MRI (region-of-interest-based and voxel-based volumetrics of frontal lobe, caudate nucleus and hippocampus)","We found that the frontal lobe showed accelerated atrophy with age, while the caudate nucleus remained relatively stable. Remarkably, the hippocampus increased in volume in all dogs. None of these changes were influenced by tacrolimus or Q134R treatment. Our results suggest that behavioral enrichment can prevent atrophy and increase the volume of the hippocampus but does not prevent aging-associated prefrontal cortex atrophy.",,,,,38561226,"A longitudinal study followed 43 middle-aged beagles (36 females, 7 males) undergoing behavioral enrichment and chronically treated with tacrolimus or Q134R, with annual MRI analysed by automated regional and voxel-based volumetrics. The frontal lobe atrophied at an accelerating rate with age, the caudate nucleus stayed relatively stable, and the hippocampus increased in volume in all dogs. Neither drug influenced these changes, which the authors attribute to behavioral enrichment preventing hippocampal atrophy without preventing prefrontal atrophy."
+loyal-stay-loy-002,STAY study: LOY-002 for healthy lifespan extension in senior dogs (Loyal),STAY,regulatory_program,ongoing,client_owned,"LOY-002, a prescription daily pill targeting age-related metabolic dysfunction",drug,placebo,daily oral tablet (dose not disclosed),four-year study,1300,any; dogs of nearly every size,"10 years or older, weighing at least 14 lb",lifespan and quality of life compared with placebo; adverse effects,,Loyal (San Francisco),Loyal,2024,,,"The STAY study is Loyal's pivotal, placebo-controlled, four-year field trial of LOY-002, a daily pill intended to extend healthy lifespan in dogs aged 10 years or older weighing at least 14 lb. Enrolment reached 1,000 dogs at 70 US veterinary clinics and was expanded to 1,300, completing in July 2025. The FDA Center for Veterinary Medicine accepted the reasonable-expectation-of-effectiveness section in February 2025 and the target-animal-safety section in January 2026 under the expanded conditional approval pathway; no efficacy results have been published."
+vaccs-cancer-preventative-vaccine,Vaccination Against Canine Cancer Study (VACCS),VACCS,randomized_controlled_trial,ongoing,client_owned,Cancer preventative vaccine targeting frameshift neoantigens conserved across multiple species and tumor histologies,vaccine,placebo,,,,,,"Cumulative incidence (CI) of dogs developing malignant neoplasia of any type at the end of the study period, in addition to safety and immunogenicity; secondary endpoints are changes in incidence of specific tumor types, survival times following neoplasia diagnosis, and all-cause mortality",,,,,,38056066,"VACCS is a randomized, placebo-controlled study protocol testing a cancer preventative vaccine against frameshift neoantigens in companion dogs, described as the largest interventional cancer clinical trial conducted in companion dogs to date. Its primary endpoint is the cumulative incidence of malignant neoplasia of any type at the end of the study period, alongside safety and immunogenicity, with secondary endpoints of specific tumor incidence, survival after neoplasia diagnosis and all-cause mortality. No results are reported in the protocol paper."
+dog-aging-project-precision-cohort,"Dog Aging Project Precision cohort (multi-omic longitudinal sub-cohort of 1,000 dogs)",,longitudinal_cohort,ongoing,client_owned,,none,,,Annual biospecimen collection; second- and third-year samples already being collected,1000,,,"Mechanisms underlying age-related change in the metabolome, microbiome and epigenome; data include complete blood count, chemistry profile, immunophenotyping by flow cytometry, metabolite quantification, fecal microbiome characterization, epigenomic profile and urinalysis",The project demonstrates that scientifically useful biospecimens can be collected from a geographically dispersed population through collaboration with private veterinary clinics and downstream labs; no age-related findings are reported in the design paper.,Dog Aging Project,,,,40038157;35110758,"The Precision cohort is a Dog Aging Project sub-cohort of one thousand dog-owner pairs recruited into strata by life stage, sex, size and geography to study age-related change in the metabolome, microbiome and epigenome of companion dogs. Blood, urine, fecal and hair samples were collected from 976 dogs by primary care veterinarians, yielding blood counts, chemistry, immunophenotyping, metabolite, microbiome, epigenomic and urinalysis data, with kits sent annually and second- and third-year samples already being collected. The design paper reports the feasibility of this collection model rather than age-related results, and the data are open to researchers on application."
+ef-m2-immutalon-geri-vital-dog-rct-2025,EF-M2 (Immutalon) macrophage glyco-modulation for activity and vitality in aging companion dogs (GERI-VITAL-DOG),GERI-VITAL-DOG,randomized_controlled_trial,completed,client_owned,"Subcutaneous EF-M2 (Immutalon), a GcMAF-derived protein for macrophage-targeted glyco-modulation",drug,"Matched placebo (identical 0.9% sodium chloride vehicle, mirror injections and mirror step-up)","0.1 ug/kg (0.1 mL/kg) subcutaneously every 72 h for 4 weeks, with protocolized blinded step-up to every 48 h at day 14 for partial responders; followed by 4 weeks off-treatment",4 weeks of treatment plus 4 weeks off-treatment (assessments to day 56),60,,>= 10 years; mean age 12.4 +/- 1.8 y,"Co-primary endpoints tested hierarchically: change in accelerometer-measured active minutes/day at week 1 and change in a day-28 vitality composite (z-score of inverted CBPI-PSS, HRQL-vitality and appetite VAS)","EF-M2 was superior to placebo on both co-primary endpoints: +23.05 min/day at week 1 (95% CI, 18.16-27.94; p < 0.001) and +2.01 z-units at day 28 (95% CI, 1.52-2.50; p < 0.001). Key secondaries favored EF-M2, including greater week-4 activity (+33.00 min/day), lower BAER auditory threshold (-5.28 dB) and reduced transepidermal water loss. Owner-reported global improvement was 93.3% vs 10.0% at day 28 and 50.0% vs 16.7% at day 56 off-treatment. Adverse events were infrequent, mild and similar to placebo.","Center for New Medical Technologies (Novosibirsk, Russia) and Triangel Scientific Research Laboratory (San Francisco, CA, USA); conducted at VEGA Veterinary Clinic and BALTO Veterinary Clinic, Novosibirsk","Activator MAF, LLC (Novosibirsk, Russia): supplied Immutalon and provided unrestricted financial support",,,41472148;41472148,"GERI-VITAL-DOG was a multicenter, randomized, double-blind, placebo-controlled trial at two referral clinics in Novosibirsk, Russia that randomized 60 client-owned geriatric dogs (10 years or older, mean 12.4 years) 1:1 to subcutaneous EF-M2 (Immutalon) at 0.1 ug/kg every 72 h for 4 weeks, with a blinded step-up to every 48 h for partial responders, or matched placebo, followed by 4 weeks off treatment. The co-primary endpoints were accelerometer-measured active minutes per day at week 1 and a day-28 vitality composite. EF-M2 beat placebo on both (+23.05 min/day; +2.01 z-units), with favorable secondaries and owner-reported global improvement of 93.3% vs 10.0% at day 28, and mild infrequent adverse events; the product and unrestricted funding came from Activator MAF, LLC."
+es-msc-and-ev-geriatric-small-dogs-cognition-mobility-pilot-2025,Human embryonic stem cell-derived MSCs and MSC extracellular vesicles in geriatric small dogs with cognitive and behavioral changes (pilot),,pilot_study,completed,client_owned,"Human embryonic stem cell-derived mesenchymal stem cells (ES-MSCs) by a single intravenous injection, or ES-MSC-derived extracellular vesicles (ES-MSC-EVs) by two subcutaneous injections",cell_or_gene_therapy,None (two active arms compared; no placebo or untreated group),ES-MSC: single intravenous injection of 1.0 x 10^7 cells for dogs 3-7 kg or 2.0 x 10^7 cells for dogs 7-12 kg; ES-MSC-EV: 1.0 x 10^10 particles per dog subcutaneously on the first day and 1 week later,2 weeks after treatment,42,Maltese and Miniature Poodle most common; mixed small breeds,11 years or older; median age 14 years (ES-MSC) and 13 years (ES-MSC-EV),Canine Cognitive Dysfunction Rating (CCDR) and Liverpool Osteoarthritis in Dogs (LOAD) scores before and 2 weeks after treatment; safety by complete blood count and serum chemistry,"No notable side effects were detected in either group, and the questionnaire survey revealed that both groups showed alleviation in CCDR and LOAD scores following administration.","Daewoong Pharmaceutical Co., Ltd., Republic of Korea (cell production and IACUC approval) with Helix Animal Hospital, Korean Animal Cancer Center and Songjeong Animal Medical Center, Seoul","No financial support declared; several authors employed by Daewoong Co., Ltd. and Daewoong Pet, Corp.",,,40206251;40206251,"A pilot study at three animal hospitals in Seoul randomly divided 42 client-owned geriatric small dogs (11 years or older, 3-12 kg, mostly Maltese and Miniature Poodles) with cognitive and behavioral changes into a group given one intravenous dose of human embryonic stem cell-derived mesenchymal stem cells (n = 21) and a group given two subcutaneous doses of ES-MSC extracellular vesicles (n = 21). CCDR and LOAD questionnaire scores and blood safety tests were compared before and 2 weeks after treatment. No notable side effects were seen and both groups showed improved CCDR and LOAD scores; there was no placebo or untreated arm."
+loyal-loy-001-large-dogs,LOY-001: IGF-1-lowering long-acting injection for large and giant breed dogs (Loyal),LOY-001,regulatory_program,ongoing,,"LOY-001, a prescription long-acting injection that reduces IGF-1 levels",drug,,injection administered by a veterinarian every three to six months,,,large and giant breeds,"7 years and older, weighing at least 40 lb",healthy lifespan extension,,Loyal (San Francisco),Loyal,,,,"LOY-001 is Loyal's long-acting injectable intended to extend healthy lifespan in large and giant breed dogs aged 7 years or older weighing at least 40 lb by lowering IGF-1, given every three to six months. The FDA accepted its reasonable-expectation-of-effectiveness technical section in 2023. No trial design or results have been published."
+loyal-loy-003-large-dogs-pill,LOY-003: IGF-1-lowering daily pill for large breed dogs (Loyal),LOY-003,regulatory_program,ongoing,,"LOY-003, a prescription daily pill targeting IGF-1 over-expression",drug,,daily oral tablet (dose not disclosed),,,large breeds,"5 years and older, weighing at least 60 lb",healthy lifespan extension,,Loyal (San Francisco),Loyal,,,,"LOY-003 is Loyal's daily pill counterpart to LOY-001, intended for large breed dogs aged 5 years or older weighing at least 60 lb and targeting IGF-1 over-expression. The company reports that its reasonable-expectation-of-effectiveness section was completed in 2026. No trial design or results have been published."

schema.json

@@ -0,0 +1,63 @@
+{
+  "$schema": "https://json-schema.org/draft/2020-12/schema",
+  "$id": "https://github.com/w0lph/k9/trials/schema.json",
+  "title": "Canine aging trial registry record",
+  "description": "One interventional study or longitudinal cohort in dogs whose stated purpose is to modify or measure aging (lifespan, healthspan, cognitive or functional decline with age, immunosenescence, age-related organ decline, or cancer prevention in older dogs). Every factual field is backed by at least one source, and every quote is verbatim from the cited source text held in this repository or in the canine-aging-corpus.",
+  "type": "object",
+  "required": ["id", "name", "kind", "status", "population", "sources", "summary"],
+  "additionalProperties": false,
+  "properties": {
+    "id": {"type": "string", "pattern": "^[a-z0-9-]+$", "description": "Stable slug, e.g. triad-rapamycin, purina-lifetime-diet-restriction."},
+    "name": {"type": "string", "description": "Short descriptive name as the registry shows it."},
+    "acronym": {"type": ["string", "null"], "description": "Acronym or code name as used by the investigators (TRIAD, STAY, LOY-002)."},
+    "kind": {"type": "string", "enum": ["randomized_controlled_trial", "controlled_trial", "single_arm_trial", "crossover_trial", "pilot_study", "longitudinal_cohort", "regulatory_program"],
+             "description": "Design as the source states it; regulatory_program for company-run programs known only from company and press sources."},
+    "status": {"type": "string", "enum": ["completed", "ongoing", "planned", "unknown"]},
+    "setting": {"type": ["string", "null"], "enum": ["laboratory_colony", "client_owned", "mixed", null]},
+    "intervention": {"type": ["string", "null"], "description": "Intervention(s) as named by the source; null for cohorts."},
+    "intervention_class": {"type": ["string", "null"], "enum": ["drug", "diet_restriction", "diet_or_supplement", "behavioral_or_environmental", "cell_or_gene_therapy", "vaccine", "combination", null, "none"]},
+    "comparator": {"type": ["string", "null"], "description": "Placebo, control diet, no treatment, etc., as stated."},
+    "dose_regimen": {"type": ["string", "null"], "description": "Dose, route and frequency exactly as reported."},
+    "duration": {"type": ["string", "null"], "description": "Treatment or follow-up duration as reported."},
+    "population": {
+      "type": "object", "additionalProperties": false,
+      "properties": {
+        "n": {"type": ["integer", "null"], "description": "Dogs enrolled or analysed, as reported."},
+        "n_note": {"type": ["string", "null"], "description": "What n counts (enrolled, randomized, analysed) or arm sizes."},
+        "breed": {"type": ["string", "null"]},
+        "age": {"type": ["string", "null"], "description": "Age range or description as reported."},
+        "other": {"type": ["string", "null"]}
+      }
+    },
+    "primary_outcome": {"type": ["string", "null"], "description": "Primary endpoint or main outcome measured, as reported."},
+    "result": {"type": ["string", "null"], "description": "Main result as the source states it, including significance wording; null if not yet reported."},
+    "lead_organization": {"type": ["string", "null"]},
+    "sponsor_or_funder": {"type": ["string", "null"]},
+    "registration": {"type": ["array"], "items": {"type": "object", "required": ["registry", "id"], "additionalProperties": false,
+                     "properties": {"registry": {"type": "string"}, "id": {"type": "string"}, "url": {"type": ["string", "null"]}}}},
+    "start_year": {"type": ["integer", "null"]},
+    "end_year": {"type": ["integer", "null"]},
+    "sources": {
+      "type": "array", "minItems": 1,
+      "items": {
+        "type": "object", "required": ["type", "quotes"], "additionalProperties": false,
+        "properties": {
+          "type": {"type": "string", "enum": ["pmid", "web", "europepmc"], "description": "pmid: a canine-aging-corpus record (abstract, or full text if fulltext_md is true); web: a snapshot under trials/data/sources/web/<slug>.txt; europepmc: an abstract under trials/data/sources/europepmc/pmid_<pmid>.json."},
+          "pmid": {"type": ["string", "null"]},
+          "slug": {"type": ["string", "null"], "description": "Web snapshot slug."},
+          "doi": {"type": ["string", "null"]},
+          "title": {"type": ["string", "null"]},
+          "year": {"type": ["integer", "null"]},
+          "role": {"type": ["string", "null"], "description": "What the source contributes: design, results, follow-up, press, company."},
+          "quotes": {"type": "array", "minItems": 1, "items": {"type": "string", "minLength": 20}, "description": "Verbatim sentences supporting the fields; checked by the validator."},
+          "quote_scope": {"type": ["string", "null"], "enum": ["abstract", "fulltext", "web", null]}
+        }
+      }
+    },
+    "summary": {"type": "string", "description": "Two to four plain sentences stating design, population, intervention, outcome and result, each supportable by the quotes."},
+    "notes": {"type": ["string", "null"], "description": "Caveats: company-sourced facts, preprint status, sub-studies of a parent study."},
+    "parent_id": {"type": ["string", "null"], "description": "id of the parent study when this record is a sub-study or follow-up."},
+    "tags": {"type": "array", "items": {"type": "string"}},
+    "extracted_by": {"type": ["string", "null"]}
+  }
+}

sources/europepmc/pmid_35679242.json

@@ -0,0 +1,10 @@
+{
+  "pmid": "35679242",
+  "pmcid": "PMC9182714",
+  "doi": "10.1371/journal.pone.0269425",
+  "title": "Cohort profile: The Golden Retriever Lifetime Study (GRLS).",
+  "journal": "PloS one",
+  "year": "2022",
+  "abstract": "The aim of this article is to provide a detailed description of the Golden Retriever Lifetime Study (GRLS), a prospective cohort study investigating nutritional, environmental, lifestyle, and genetic risk factors for cancer and other common diseases in dogs. Primary outcomes of interest include hemangiosarcoma, lymphoma, osteosarcoma, and high-grade mast cell tumors. Secondary outcomes of interest include other cancers, hypothyroidism, epilepsy, atopy, otitis externa, hip dysplasia, heart failure, and renal failure. A total of 3,044 United States Golden Retrievers aged 6 months to 2 years completed baseline enrollment from June 2012 to April 2015. As of May 31, 2021, 2,251 dogs remain engaged in the study, 352 have died, and 441 are lost to follow-up. Extensive annual questionnaires completed by owners and veterinarians gather information about lifestyle, environmental exposures, physical activity, reproductive history, behavior, diet, medications, and diagnoses. Dogs also have annual veterinary examinations and biospecimen collection (blood, serum, hair, nails, feces, urine) for biobanking. Additional reporting, including histology and tumor biobanking, is conducted for any malignancies or deaths. When an animal dies, full medical records are obtained, and necropsies are requested at owner discretion. Full or partial necropsies have been performed on 218 dogs. Questionnaire data are freely available to researchers with approved credentials who agree to a data use agreement. In addition, researchers can submit proposals to utilize biospecimens or obtain additional data.",
+  "retrieved_at": "2026-10-01T14:23:07+00:00"
+}

sources/web/dvm360-stay-enrollment.txt

@@ -0,0 +1,109 @@
+Clinical trial for Longevity drug meets goal of enrolling 1000 dogs | dvm360 --> 
+
+ --> 
+
+ Advertisement
+
+ News | Articles | April 14, 2025 
+
+ Clinical trial for Longevity drug meets goal of enrolling 1000 dogs
+
+ Author(s) Kristen Coppock Crossley, MA 
+
+ The STAY study is investigating LOY-002, a therapy designed by Loyal to extend healthy lifespans in canines
+
+ Advertisement
+
+ The STAY study, a clinical trial investigating the developmental longevity drug LOY-002, has reached its goal of enrolling 1000 canine patients at 70 veterinary clinics across the US. According to Loyal, the biotechnology company developing LOY-002, this 4-year study may be the world’s largest veterinary clinical trial, and a new goal has been set for expanding the trial to include an additional 300 patients. 1 
+ “The STAY study is our pivotal field trial. This is the key component in getting FDA approval for LOY-002,” Brennen McKenzie, VMD, MSc, MA, director of veterinary medicine for Loyal, said in a dvm360 interview.
+ LOY-002 is being developed to extend healthy lifespan in senior dogs by improving metabolic health to delay the onset and reduce the impact of age-associated diseases. Launched in December 2023, the study’s first patient, an 11-year-old Whippet named Boo, was enrolled at the Animal Hospital of Dauphin County in Harrisburg, Pennsylvania. 2 The milestone 1000th patient was Winston, age 10 years, a miniature dachshund receiving veterinary care at the Franklin Animal Clinic in Indiana. 1 
+ The STAY study goes beyond investigation of longevity. It also measures quality of life based on pet owners’ assessments of their dogs, according to Ellen Ratcliff DVM, vice president of clinical and veterinary medicine at Loyal. “It doesn’t do anybody any good if their dog lives longer, but they live longer in that period at the end of their life where they don’t feel well, and they’re sick, having all kinds of degenerative and aging diseases,” Ratcliff said in an earlier dvm360 interview.
+
+ astro-island:empty]:hidden"> 
+ Advertisement
+
+ With the STAY study, LOY-002 is being prescribed by veterinarians and administered to enrolled patients as a daily beef-flavored pill. Dogs age 10 years or older and weighing at least 14 pounds are eligible. 2 
+ Over the study’s span, Loyal is collecting data on the drug’s potential impact on the lifespan and quality of life for dogs receiving LOY-002, compared to those receiving a placebo, as well as any adverse effects reported in the study population. 2 
+ A total enrollment of 1300 canine patients would translate to an increase in the study’s sample size, providing even more scientific data for observing the drug’s effects. 1 The additional 300 patients “is going to give us even more power to be able to look at the effects of our drug on lifespan and health and wellbeing in these dogs,” McKenzie noted.
+ “I'm excited because I'd like to see the drug made available to veterinarians and dog owners, but I'm [also] excited because it's going to be a treasure trove of data on canine aging and how they age, and what we can potentially learn that we could then use to develop other targets to do things to help them live longer, healthier lives,” he added.
+ Reaching the milestone of 1000 enrolled patients follows Loyal’s February 2025 announcement that the FDA’s Center for Veterinary Medicine granted acceptance of the Reasonable Expectation of Effectiveness (RXE) section of the conditional approval application for LOY-002. 3 
+ Ratcliff noted that the RXE acceptance was an achievement that serves as a testament to the importance of the STAY study. Celine Halioua, CEO of Loyal, said RXE acceptance was important for advancing LOY-002. 3 
+ “Everything we do is in service of helping dogs live longer, healthier lives,” Halioua said. 3 “These 2 milestones represent our ongoing commitment to that mission through years of diligence and hard work. Proving efficacy is one of the most challenging parts of developing a novel drug. While we still have significant work to do, RXE increases the probability that dogs will soon have access to our longevity drugs.”
+ In the meantime, McKenzie advised veterinary professionals to never accept ‘old age’ as an explanation for a patient’s condition, and keep in mind there are likely things that can be done to help improve outcomes. “What you can do now is what you already know,” he said. “Keep them a healthy weight, keep them engaged and active. Keep up with your preventive medicine, and watch this space, because there's going to be new things that you can do that we didn't even think were possible a few years ago.”
+ References 
+ Lee J. Breaking records: the STAY study enrolls 1,000 dogs. News release. Loyal. April 14, 2025. Accessed April 14, 2025. https://loyal.com/posts/stay-enrolls-1000-dogs 
+ A clinical trial is launched for a novel drug that could extend healthy lifespan in senior dogs. dvm360 . February 1, 2024. Accessed April 14, 2025. https://www.dvm360.com/view/a-clinical-trial-is-launched-for-a-novel-drug-that-could-extend-healthy-lifespan-in-senior-dogs 
+ Crossley KC. Second drug for canine healthy lifespan extension receives FDA support. dvm360 . February 26, 2025. Accessed April 14, 2025. https://www.dvm360.com/view/second-drug-for-canine-healthy-lifespan-extension-receives-fda-support 
+
+ Advertisement
+
+ Related to this article
+
+ View more 
+
+ September 29th, 2026 Fungus-contaminated wound product linked to infections in nearly 100 horses, at least 20 euthanized 
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+ A technician’s approach to veterinary trauma
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+ dvm360's Australian correspondent Phil Tucak, BSc, BVMS, reports on the success of the new membership model at the Australian Veterinary Association, and reforms to the veterinary regulatory framework in New South Wales.
+
+ Read more 
+
+ September 30th, 2026 Matching relapsed lymphoma treatment to drug-response predictions tied to lower daily costs in dogs 
+ A new cost analysis finds that matching relapsed lymphoma treatment to a personalized drug-response test was associated with longer disease control and a lower estimated daily treatment cost in dogs.
+
+ Read more 
+
+ September 30th, 2026 FAQ: Rising rabies exposure calls put PEP decisions back in focus 
+ Following World Rabies Day and a CDC health advisory on a 17% rise in exposure-related calls, Rodney E. Rohde, PhD, explains what the increase means, what people should do when they have an animal bite or scratch, and how clinicians should assess risk and administer post-exposure prophylaxis (PEP).
+
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+
+ September 30th, 2026 Saline injection lot recalled after potassium chloride bag found in mislabeled wrap 
+ One lot of 0.9% sodium chloride injection may contain bags of concentrated potassium chloride, a mix-up the manufacturer says could cause serious or fatal adverse events.
+
+ Read more 
+
+ September 30th, 2026 Pet Poison Helpline reports rise in Apoquel calls 
+ Accidental ingestion, not a drug defect, is behind the increase in calls, according to Pet Poison Helpline.
+
+ Read more 
+
+ Previous slide Next slide 
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+ Trending on dvm360
+ 1
+
+ Pet Poison Helpline reports rise in Apoquel calls
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+ 2
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sources/web/dvm360-stay-milestone.txt

@@ -0,0 +1,111 @@
+Lifespan extension drug in development for senior dogs reaches a new milestone | dvm360 --> 
+
+ --> 
+
+ Advertisement
+
+ News | Articles | January 13, 2026 
+
+ Lifespan extension drug in development for senior dogs reaches a new milestone
+
+ Author(s) Kristen Coppock Crossley, MA 
+
+ Fact checked by: Yasmeen Qahwash 
+
+ Loyal’s application for drug approval is another step closer to potential approval through the FDA Center for Veterinary Medicine. 
+
+ Advertisement
+
+ A drug in development for healthy lifespan extension in senior canines has reached a new milestone on the path toward potential FDA approval. The conditional approval application for the drug LOY-002, created by Loyal, has had its target animal safety (TAS) technical section accepted by the federal agency, according to the biotechnology animal health company. 1 
+ The drug’s application has now received acceptance for 2 of 3 major technical sections required for market launch, according to Loyal. 1 The FDA Center for Veterinary Medicine previously granted the application a reasonable expectation of effectiveness designation 2 ; its manufacturing section will need to be accepted before conditional approval can be considered.
+ “As a veterinarian, what I care about most, especially when it involves preventive care, is safety,” Ellen Ratcliff, DVM, vice president of clinical and veterinary medicine at Loyal, said in a news release. 1 “The FDA’s sign off on this submission is an important vote of confidence in our mission to develop safe and effective lifespan extension drugs for dogs.”
+ Loyal anticipates the final major technical section to be reviewed in 2027. 1 Brennen McKenzie, VMD, MSc, MA, director of veterinary medicine for Loyal, said the mechanical section of LOY-002’s application is in progress. “Full approval would follow after completion of the STAY study, which is the pivotal effectiveness trial required to support a future full [new animal drug application] approval,” he said in a dvm360 interview.
+
+ astro-island:empty]:hidden"> 
+ Advertisement
+
+ LOY-002 is a prescription daily pill that targets age-related metabolic dysfunction and is designed to improve quality of life in canines 10 years and older, weighing at least 14 lb. 2 “The metabolic dysfunction that all dogs experience as they age is a critical risk factor for many of the health problems that impact senior dogs. By improving metabolic health, we believe LOY-002 will extend not only lifespan but [also] health span—the time that dogs are healthy and still able to enjoy their favorite activities and time with their human family,” McKenzie said.
+ The submission for TAS acceptance included evidence from several scientific investigations. “Among these was a safety study conducted at the standard 1-, 3-, and 5-times dose strengths, with no clinically significant adverse events observed at these doses,” McKenzie said. “Safety has been a central focus of LOY-002’s development from the outset. Preventive therapies that are prescribed to otherwise healthy dogs require a very high safety bar, and we are pleased that the FDA agrees that the data support LOY-002’s safety for the proposed conditions of use.”
+ Scientific evidence also included the ongoing STAY study, which completed patient enrollment with 1300 dogs at 70 veterinary clinics across the US in July 2025. 1,3 “We evaluated field safety data from 400 dogs enrolled in the STAY study. The FDA then reviewed our submission and determined that LOY-002’s data support the drug's safety for the proposed conditions of use,” McKenzie added.
+ “In both the standard safety study and the field data from STAY, a wide range of data were collected. The dogs were closely monitored, including regular examinations and laboratory testing,” he continued. 
+ The data submitted to the FDA included information from dogs given LOY-002 for up to 1 year, and patients with a variety of ongoing medical conditions and other treatments commonly seen in senior dogs were included. The agency agreed that these data support the conclusion that LOY-002 is safe for its intended use.
+ If LOY-002 is ultimately approved by the FDA, it would be the agency’s first drug approval for lifespan extension in any species, Loyal noted. As it stands, the drug received the first known safety acceptance for a lifespan extension drug from the FDA with TAS support. 1 
+ “Since founding Loyal 6 years ago, my goal has always been to get the first drug FDA approved for lifespan extension. This safety acceptance brings us very close to achieving that vision.” Celine Halioua, founder and CEO of Loyal, said in a news release. 1 “We are well on our way to bringing the first dog longevity drugs to market.”
+
+ References 
+ Loyal receives FDA acceptance of safety package for senior dog lifespan extension drug. News release. Loyal. January 13, 2026. https://www.businesswire.com/news/home/20260113476778/en/Loyal-Receives-FDA-Acceptance-of-Safety-Package-for-Senior-Dog-Lifespan-Extension-Drug 
+ Crossley KC. Second drug for canine healthy lifespan extension receives FDA support. dvm360 . February 26, 2025. Accessed January 13, 2026. https://www.dvm360.com/view/second-drug-for-canine-healthy-lifespan-extension-receives-fda-support 
+ Crossley KC. Clinical trial for longevity drug meets goal of enrolling 1000 dogs. dvm360 . April 14, 2025. Accessed January 13, 2026. https://www.dvm360.com/view/clinical-trial-for-longevity-drug-meets-goal-of-enrolling-1000-dogs 
+
+ Advertisement
+
+ Related to this article
+
+ View more 
+
+ September 29th, 2026 Fungus-contaminated wound product linked to infections in nearly 100 horses, at least 20 euthanized 
+ FDA testing found 5 fungal species, including one known for antifungal resistance, in Neogen Vet HYCOAT, a product labeled as sterile.
+
+ Read more 
+
+ September 23rd, 2026 Laverdia now available for purchase for dogs with lymphoma 
+ Verdinexor tablets are now available for dogs with lymphoma after receiving full FDA approval earlier this year, offering an at-home treatment option given twice weekly and showing a longer time to disease progression than the control in a field study.
+
+ Read more 
+
+ October 1st, 2026 Staying calm under pressure 
+ A technician’s approach to veterinary trauma
+
+ Read more 
+
+ September 30th, 2026 Veterinary Scene Down Under: Australian Veterinary Association membership grows and New South Wales moves to recognize veterinary technicians 
+ dvm360's Australian correspondent Phil Tucak, BSc, BVMS, reports on the success of the new membership model at the Australian Veterinary Association, and reforms to the veterinary regulatory framework in New South Wales.
+
+ Read more 
+
+ September 30th, 2026 Matching relapsed lymphoma treatment to drug-response predictions tied to lower daily costs in dogs 
+ A new cost analysis finds that matching relapsed lymphoma treatment to a personalized drug-response test was associated with longer disease control and a lower estimated daily treatment cost in dogs.
+
+ Read more 
+
+ September 30th, 2026 FAQ: Rising rabies exposure calls put PEP decisions back in focus 
+ Following World Rabies Day and a CDC health advisory on a 17% rise in exposure-related calls, Rodney E. Rohde, PhD, explains what the increase means, what people should do when they have an animal bite or scratch, and how clinicians should assess risk and administer post-exposure prophylaxis (PEP).
+
+ Read more 
+
+ September 30th, 2026 Saline injection lot recalled after potassium chloride bag found in mislabeled wrap 
+ One lot of 0.9% sodium chloride injection may contain bags of concentrated potassium chloride, a mix-up the manufacturer says could cause serious or fatal adverse events.
+
+ Read more 
+
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sources/web/gizmodo-loy-001.txt

@@ -0,0 +1,387 @@
+New Drug Could Extend the Lifespans of Giant Dog Breeds 
+
+ Skip to content
+
+ Biology
+
+ New Drug Could Extend the Lifespans of Giant Dog Breeds
+
+ The drug, LOY-001, could be available to the public as soon as 2026.
+
+ By
+
+ Isaac Schultz 
+
+ Published November 28, 2023, 5:15 pm ET
+
+ Reading time 2 minutes
+
+ A Kangal dog in Sivas, Turkey. Photo: Serhat Zafer/Anadolu Agency (Getty Images)
+
+ Read Later 
+
+ Read Later 
+
+ Comments 
+
+ (0)
+
+ The animal pharmaceutical company Loyal announced that the FDA has accepted the development of a drug that could extend the lifespans of large and giant dog breeds.
+ The drug is codenamed LOY-001. In a blog post published today, Celia Halioua, the founder and CEO of Loyal, said that the company earned the FDA’s acceptance of the drug. “In regulatory parlance,” Halioua wrote , “we have completed the technical effectiveness portion of our conditional approval application for LOY-001’s use in large dog lifespan extension.”
+
+ Giant dogs are the ones that might make you gawk on the street: Great Danes, Irish wolfhounds, and Anatolian shepherds to name a few. But most of these massive dogs average a very short lifespan—about 9 years for a Great Dane, and just 6 or 7 years for an Irish wolfhound.
+ Small dogs can live three times as long as the shortest-lived giant dog breeds, according to the American Kennel Club ; the dogs die mostly from cancer and age-related illnesses, which indicate that larger dogs tend to age faster than their smaller compatriots.
+
+ A Great Dane (left) and a petite French bulldog. Photo: Mark Stewart/Newspix (Getty Images) As previously reported by Gizmodo in our list of unhealthy dog breeds , giant breeds are vulnerable to skeletal problems like hip dysplasia, a deformity that leads to chronic arthritis. (Though the most common cause of death in Irish wolfhounds is cancer, followed by cardiovascular disease.)
+
+ “The extreme phenotypic variety found in dogs is not ‘natural’ — it’s the result of intensive breeding by humans to create dogs that excelled at tasks such as herding, protection, and companionship,” Brennen McKenzie, Loyal’s Director of Veterinary Medicine, said in a press release . “At Loyal, we see the short lifespan of big dogs not as inevitable, but as a genetically-associated disease caused by historical artificial selection, and therefore amenable to targeting and treatment with a drug.”
+
+ According to Halioua’s post, breeding large dogs for their size caused elevated levels of IGF-1, a hormone that promotes cell growth. Though this hormone contributes to the animals’ great size, it also hastens their aging. LOY-001 reduces the levels of IGF-1 in large and giant dog breeds, extending healthy life spans.
+
+ The drug is an injectable that would be administered by a vet every three to six months. Loyal is also developing a pill that would address the same issue, codenamed LOY-003. According to the release , LOY-001 could hit the shelves by 2026, pending FDA approval of data provided to them by Loyal.
+ The road to an FDA-approved drug is long, but there’s reason to be optimistic about the currently short lives of big dogs.
+ More: Why Purebred Dogs Are Sick, Miserable, and Ugly 
+
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sources/web/longevity-technology-2026-01-14.txt

@@ -0,0 +1 @@
+403 - Forbidden | Access to this page is forbidden.

sources/web/loyal-for-dog-owners.txt

@@ -0,0 +1,155 @@
+Loyal | For dog owners 
+ Skip to main content Big news for big dogs! LOY-003 hits key FDA milestone. Read more → 
+ The first longevity drugs for your dog 
+
+ Mae
+ Age 15
+
+ Take that, aging.
+ The effects of aging are often accepted as a fact of life. As your dog gets older, their quality of life declines and they’re more likely to develop chronic diseases. We challenge the notion that nothing can be done about this.
+
+ Peeper
+ Daughter | age 3 
+
+ Ren
+ Mom | age 8 
+
+ Eva
+ Grandma | age 13 
+
+ How aging affects dogs
+ You notice changes in your older dog’s behavior. Energy levels decrease, enthusiasm declines, and they walk more stiffly or can’t see as well. They may develop chronic health problems — like arthritis, kidney disease, or heart disease. These are just a few of the ways aging manifests in our dogs.
+ Explore signs of aging 
+
+ We’re pursuing FDA approval* for the first ever longevity drugs to address the collective impact of aging in your dog and to give your dog a longer, healthier life.
+ *FDA approval not guaranteed
+
+ A pill to give your dog more healthy years
+
+ LOY-002 is our drug for senior dogs , a daily pill intended to help dogs of nearly every size live a longer, healthier life.*
+ As your dog gets older, their metabolic health declines, driven in part by higher insulin levels and insulin resistance. These changes increase their risk of developing age-associated diseases and decrease quality of life. LOY-002 is intended for dogs aged 10 and older and weighing at least 14 lb. It aims to extend healthy lifespan by improving insulin sensitivity and lowering insulin, giving you and your dog more good years together.
+ As of December 2025, LOY-002 has completed two of the three major requirements needed for FDA conditional approval: safety and efficacy. These acceptances mean the FDA agrees that the drug is likely to be effective and safe when used as intended.
+ *FDA approval not guaranteed
+ Dive into metabolic dysfunction 
+
+ Harper
+ Age 11
+
+ Drug availability
+ We’re going through the rigorous FDA approval process to get the drug to your dog as soon as possible.
+ Efficacy
+ Reasonable expectation of effectiveness (RXE)
+
+ Safety
+ Target animal safety (TAS)
+
+ Manufacturing
+ Chemistry, manufacturing, and controls (CMC)
+
+ FDA Expanded conditional approval* (XCA)
+
+ *FDA approval not guaranteed
+ This is a simplified representation of the FDA approval pathway. To see the entire process, view the full roadmap.
+ View full roadmap 
+
+ Efficacy
+ Reasonable expectation of effectiveness (RXE)
+
+ Safety
+ Target animal safety (TAS)
+
+ Manufacturing
+ Chemistry, manufacturing, and controls (CMC)
+
+ FDA Expanded conditional approval* (XCA)
+
+ View full roadmap *FDA approval not guaranteed
+ This is a simplified representation of the FDA approval pathway. To see the entire process, view the full roadmap.
+
+ More time for big dogs
+ Our other drugs in development are for large and giant dogs . Large body size in dogs is correlated with shortened lifespan, so the larger a dog is, the shorter average lifespan that dog will have. LOY-001 is intended for dogs 7 years and older, weighing at least 40 lb, whereas LOY-003 is developed for dogs 5 years and older, weighing at least 60 lb. Both drugs target the over-expression of IGF-1, a growth hormone that we believe is associated with large dogs’ shorter lifespan relative to small dogs.
+ LOY-001 is a prescription long-acting injection, while LOY-003 is a prescription daily pill. LOY-001 received a Reasonable Expectation for Effectiveness (RXE) technical section complete letter in 2023 — the FDA’s first-ever formal acceptance that a drug can be developed and approved to extend lifespan, and a historic milestone for Loyal. In 2026, LOY-003 completed its RXE section.
+ *FDA approval not guaranteed
+
+ Akila
+ Age 7
+
+ Committed to your dog’s safety 
+ Our drugs are preventive in nature. While even serious side-effects may be tolerable with a medication intended to treat a severe or life-threatening disease, preventive treatments should be as safe as possible.
+ Our dog longevity drugs are all being developed under the FDA Center for Veterinary Medicine’s expanded conditional approval (XCA) pathway. This approach is designed to get the drug to you as soon as possible, with the same safety and manufacturing quality standards as a fully approved drug. Read more about what XCA means for Loyal’s products.
+ Learn about FDA conditional approval 
+ Melody
+ Age 12
+
+ Safety is important for new drugs in any species, and dogs are no exception. The FDA Center for Veterinary Medicine (CVM) has guidelines around required safety studies, including evaluating the drug at doses higher than your dog would receive and also in dogs over long periods of time.
+ In December 2025, the CVM accepted LOY-002’s Target Animal Safety (TAS) submission, meaning the agency agrees that the data supports the drug’s safety for its intended use.
+ The TAS package included a standard safety study (conducted at 1x, 3x, and 5x) that observed no clinically significant adverse events. We also shared additional field safety data from 400 senior companion dogs enrolled in the STAY study. We’ll be able to share more data as we get closer to launch.
+ As our other drug programs advance through the FDA approval process, we’ll be able to share more information about their safety and efficacy as well.
+
+ Emmy
+ Age 4
+
+ More
+ walks
+ walks play fetch days walks 
+
+ We’re a community of vets, scientists, and dog lovers 
+
+ We understand how special the dog-human bond is, and we’re committed to supporting this relationship. We have a deep respect for the vet community and their role in supporting the dogs we love and their owners.
+ Meet our team 
+
+ Resources for you and your aging dog
+ Recognize signs of your aging dog
+
+ Learn more 
+ What you can do now to slow your dog’s aging
+
+ Learn more 
+ Resources for grieving dog owners
+
+ Coming soon 
+
+ Q&A
+ What is a “longevity drug”?
+ A “longevity drug” is a new concept. Currently, medicines on the market target disease after symptoms have already appeared. Our approach is preventive — we aim to address the underlying causes of disease before they even start to appear. 
+
+ For example, when a dog gets old, they may be diagnosed with arthritis. We call this the binary, 0 to 1, approach. The reality is, the dog’s health was likely already declining before the point that the disease started to show and present itself as arthritis. This is the aim of a “longevity drug”: to target the cause of the diseases before they get severe enough to diagnose. 
+
+ If dogs are living longer, are you just extending their number of frail days towards the end of life?
+ Quality of life as a dog ages is just as important as the amount of time they have. Our goal is to increase the amount of healthy years your dog lives. 
+
+ What if my dog doesn’t qualify for the drug?
+ We expect to support the following populations with our drugs: 
+ For senior dogs 
+ For LOY-002: dogs 10 years and older and weighing at least 14 lb 
+
+ For large and giant dogs 
+ For LOY-001: dogs 7 years and older and weighing at least 40 lb 
+
+ For LOY-003: dogs 5 years and older and weighing at least 60 lb 
+
+ When we designed our four-year clinical study for LOY-002 (which is already longer than typical), we chose to target 10+ year dogs to balance comprehensive research with speed. If we included younger dogs in the study, we would have had to run the study for longer than four years to show lifespan extension, delaying the full approval for more years. We hope to demonstrate our drugs' efficacy on younger dogs in additional studies to expand eligibility. 
+
+ What safety information can you share?
+ Safety is our first priority at Loyal, and we strongly believe that if our product is unsafe, it shouldn’t go to market. 
+ In December 2025, the FDA accepted LOY-002’s Target Animal Safety (TAS) submission, which included data from several studies. The FDA determined in its review that the data supports the drug’s safety for its intended use.  
+ We’re pursuing the same high standard for LOY-001 and LOY-003, our other drugs in development, and will share information as these programs progress. 
+ Throughout the approval process, all safety data is submitted to the FDA for review, which has supported continued development of our product. We’ll be able to share this data as we get closer to launch, and we’ll disclose any side effects seen in any of our studies that are associated with our drugs. 
+ See our safety section for more information . 
+
+ What’s the difference between a supplement and an FDA-approved drug?
+ Supplements are not held to the same standard of rigorous safety and effectiveness screening, independent analysis, and regulation as drugs approved by the FDA. 
+ Unlike drugs, supplements are often not monitored and their manufacturers are not required to run studies to show that their products work. If they do run safety studies, the research may not be independently verified. 
+ On the FDA website, they write “The benefit of the FDA’s drug approval process is the assurance that an approved animal drug is safe, effective, and high-quality.” 
+
+ Harper
+ Age 11
+
+ Melody
+ Age 12
+
+ Chase
+ Age 12
+
+ Milo
+ Age 10

sources/web/loyal-products-in-development-2024-08.txt

@@ -0,0 +1,298 @@
+Helping dogs live longer, healthier lives
+Our aging thesis
+Aging is the most significant modifiable risk factor for 
+most degenerative and chronic diseases in adult dogs. 
+Targeting the ways dogs age and decline over time 
+may be one of the most effective and practical ways for 
+veterinarians to increase the healthy lifespan of their 
+canine patients.
+At Loyal, our approach is to help dogs live longer and 
+stay healthier as they age by targeting the underlying 
+processes that lead to age-associated disease and 
+disability. Our drugs aim to extend lifespan and quality 
+of life by reducing the incidence or severity of  
+age-related diseases. 
+Products in development
+We have three lifespan extension drugs in development, 
+targeting two molecular pathways.
+LOY-002 is intended for dogs age 10 or older and 
+weighing at least 14 lb. It aims to extend healthy 
+lifespan by mitigating age-associated metabolic 
+dysfunction.
+LOY-001 and LOY-003 are intended for dogs age 7 
+and older and weighing 40 lb or more and target the 
+over-expression of IGF-1, a hormone that we believe is 
+associated with large dogs’ shorter lifespan relative to 
+small dogs. 
+Senior dog  
+lifespan extension
+Large dog  
+lifespan extension
+Development name LOY-002 LOY-001 LOY-003
+Description As dogs age their metabolic 
+health declines, leading 
+to disease and declining 
+quality of life. LOY-002 
+is believed to improve 
+metabolic health with 
+the aim of reducing age-
+associated disease and 
+extending healthy lifespan.
+As a result of selective 
+breeding, large dogs produce 
+more of the hormone IGF-1 
+than required post-maturity. 
+This is believed to reduce 
+their lifespan relative to 
+smaller dogs.
+LOY-001 addresses this 
+overexpression in adult dogs 
+with the aim of reducing 
+age-associated diseases and 
+extending healthy lifespan. 
+LOY-003 targets the same 
+IGF-1 overexpression as 
+LOY-001. 
+Target population Dogs age 10 or older and
+weighing at least 14 lb.
+Dogs age 7 or older and  
+weighing at least 40 lb.
+How supplied Prescription daily  
+flavored pill Prescription injection Prescription daily pill
+Planned launch 2025 2027 2027
+
+Mechanism of action
+Disclaimer: because this product is still in development, 
+the drug and its exact mechanism of action currently 
+necessarily remain confidential. For now, we can only 
+discuss our approach in general terms. However, we 
+continue to publish our pre-clinical research data, and 
+much more detailed information will be made available to 
+veterinarians if the drug is approved for use by the FDA.
+LOY-002 is designed to be a daily flavored tablet 
+given to dogs with the aim of extending lifespan and 
+mitigating the decline in health and quality of life 
+associated with aging. We believe it will accomplish this 
+by addressing several aspects of the overall metabolic 
+dysfunction that occurs with aging.
+-> Read our high-level introduction to 
+metabolic dysfunction.
+There is already some compelling evidence that 
+targeting metabolic dysfunction can extend healthspan 
+and lifespan. Caloric restriction is a commonly used 
+research intervention to improve metabolic health and 
+extend lifespan in mammals from mice to primates. 
+A landmark study found that calorically restricted 
+Labrador Retrievers lived almost two years longer on 
+average than dogs fed to a normal body condition.1 The 
+calorie-restricted group also had significantly lower 
+prevalence of common age-associated diseases, such 
+as osteoarthritis and neoplasia.1,2
+While caloric restriction itself is not a practical way to 
+extend lifespan in pet dogs, this study showed that 
+improving metabolic health can have a direct and 
+significant impact on lifespan in dogs. We believe drugs 
+will be a more targeted and pragmatic approach to 
+achieving similar benefits. Our aim with LOY-002 is to 
+preserve metabolic health, which we believe will delay 
+the onset of age-associated disease and help dogs 
+maintain better function and quality of life. 
+The STAY study
+This is a double-blinded, placebo-controlled efficacy 
+study intended to assess the effect of LOY-002 on 
+lifespan and healthspan in treated dogs. The STAY 
+study will be conducted over four years in partnership 
+with 55 veterinary clinics across the country. Roughly 
+1,000 companion dogs 10 years and older and between 
+14 and 179 pounds will participate. In December of 
+2023, we enrolled the first dog in the STAY study, and 
+we’re actively recruiting patients.
+Over the span of STAY, we’ll collect extensive data on 
+health, quality of life, and lifespan in dogs receiving 
+LOY-002 and those receiving a placebo. The results 
+of the study will be part of our application for full FDA 
+approval for the drug for lifespan extension and will also 
+be shared with veterinarians. 
+Conditional approval
+While conducting this unprecedented canine lifespan 
+study, we’re also pursuing conditional approval for 
+LOY-002 based on existing efficacy, safety, and 
+manufacturing data. 
+The FDA Center for Veterinary Medicine’s expanded 
+conditional approval pathway is meant for animal drugs 
+that address an unmet medical need and require long 
+or complex studies to complete the collection of the 
+effectiveness data needed for full approval. Conditional 
+approval has the same strict safety and manufacturing 
+quality requirements as full approval, but it is a way 
+to make needed drugs available to veterinarians more 
+rapidly based on evidence showing a Reasonable 
+Expectation of Effectiveness (RXE). RXE can be 
+supported by evidence from various sources, including 
+the scientific literature and pre-clinical or pilot studies, 
+which are often smaller and shorter than trials like the 
+STAY study. 
+Loyal is committed to following the rigorous scientific 
+and manufacturing standards set by the FDA, and 
+product timelines will depend on our ongoing work 
+with the agency to meet those standards. However, 
+if the FDA grants conditional approval for LOY-002, 
+veterinarians may be able to prescribe the drug as soon 
+as 2025 while the STAY study continues to gather the 
+data required for full approval. 
+Safety
+Because LOY-002 is part of a preventive medicine 
+approach to aging and not a treatment for one specific 
+disease, we consider safety to be of the utmost 
+importance. While even serious side effects may be 
+LOY-002
+Lifespan extension for dogs age 10 or older and weighing at least 14 lb
+
+Safety (cont.)
+tolerable with a medication intended to treat a severe or 
+life-threatening disease, preventive treatments such as 
+LOY-002 should be as safe as possible.
+We have extensive evidence from safety studies of 
+the active ingredient in LOY-002. Over 400 dogs have 
+been given the active ingredient in LOY-002 in multiple 
+laboratory studies lasting from four weeks to a full year. 
+This data has supported further development of the  
+drug, and we’ve submitted it to the FDA. This includes 
+studies at doses much higher than will be used in dogs 
+treated with LOY-002. We have data from a 3-month 
+pilot clinical trial with LOY-002 tablets where there 
+were no clinically significant adverse effects. We are 
+also running a 6-month study to assess the safety 
+of LOY-002 tablets at up to five times the expected 
+prescription dose. 
+LOY-002 (cont.)
+Lifespan extension for dogs age 10 or older and weighing at least 14 lb
+
+Mechanism of action
+LOY-001 and LOY-003 both address the premature 
+morbidity and mortality of large-breed dogs. LOY–001 
+will be an injectable administered by veterinarians 
+every three to six months. LOY-003 will be a daily 
+pill developed through our partnership with human 
+biopharma company Crinetics Pharmaceuticals.
+It is well-known that body size and lifespan are related 
+in dogs and that larger dogs often have substantially 
+shorter lifespans than smaller dogs. Larger body size 
+is predominantly determined by the levels of certain 
+hormones during development, including growth 
+hormone (GH) and insulin-like growth factor 1 (IGF-1). 
+However, these hormones have effects on metabolism 
+other than stimulating growth. 
+There is extensive evidence in many species, including 
+dogs, showing a correlation between high IGF-1 levels 
+and shorter lifespan, and this is considered one of the 
+core pathways of aging.3 We believe that sustained 
+higher levels of GH and IGF-1 in larger dogs are 
+partly responsible for shorter lifespan and the earlier 
+development of age-associated disease and disability. 
+If we are correct, then LOY-001 and LOY-003 will extend 
+lifespan in part by reducing IGF-1 levels and delaying 
+the onset of age-associated metabolic dysfunction 
+and disease. These drugs will be administered only to 
+skeletally mature dogs, not puppies, so they will not 
+affect adult body size.
+ 
+Working toward FDA approval
+As with LOY-002, we are planning to seek full approval 
+for LOY-001, which includes conducting a large, long-
+term efficacy trial similar to the STAY study. We hope 
+to begin this study in 2025. We do not yet have clinical 
+study plans or timelines to announce for LOY-003.
+We are also seeking conditional approval for these 
+drugs to address the unmet need of early mortality in 
+large dogs due to age-associated disease. Late last 
+year, the FDA accepted the technical effectiveness 
+portion of our conditional approval application, 
+determining that we had met the criteria for RXE. We 
+believe this to be the FDA’s first-ever formal acceptance 
+that a drug can be developed and approved to extend 
+lifespan. This is only one of several elements in seeking 
+conditional approval, but it is an important milestone.
+If the FDA grants conditional approval for LOY-001, 
+veterinarians may be able to prescribe the drug as 
+soon as 2026. As always, these timelines will depend 
+on our ongoing work to meet the rigorous scientific and 
+manufacturing standards set by the FDA.
+Safety
+Both LOY-001 and LOY-003 are in early-stage 
+development, and safety data is being gathered for 
+both of these drugs. As with LOY-002, continued 
+development of these products and potential FDA 
+approval will require equally robust evidence ensuring 
+safety as well as efficacy.
+LOY-001 and LOY-003
+Lifespan extension for dogs age 7 or older and weighing at least 40 lb
+
+What are the potential benefits of your drugs?
+The goal of all our programs is to develop  
+FDA-approved drugs that extend healthy lifespan 
+in dogs. By targeting specific pathways that lead to 
+metabolic dysfunction, we believe we can delay  
+age-associated disease and disability and give 
+companion dogs substantially more time with good 
+health, physical function, and quality of life. The STAY 
+study and our other ambitious clinical trials will provide 
+much more detail about the impacts of our drugs on 
+health and lifespan.
+What are the active pharmaceutical ingredients 
+in your drugs?
+Because our products are still in development, the 
+drugs and their exact mechanisms of action necessarily 
+remain confidential. We’ll release these details — along 
+with safety and efficacy data — as we get closer to 
+launching each product.
+Do your drugs treat specific cancers or other 
+age-related diseases?
+Our goal is to develop medications that preserve health 
+and broadly delay or prevent age-associated disease 
+rather than focusing on treating specific diseases after 
+they have already developed.
+Do dogs need to be healthy when taking  
+your drugs?
+We expect dogs with many pre-existing conditions will 
+be able to take our drugs and benefit from them, but 
+any specific guidelines will be based on the results of 
+our clinical and safety studies.
+What about younger or smaller dogs?
+We expect to support the following populations  
+with our drugs:
+-> For LOY-001 and LOY-003, dogs 7 years and older  
+    and at least 40 pounds
+-> For LOY-002, dogs 10 years and older and between  
+    14 and 179 pounds
+Clinical studies are designed to measure effectiveness 
+among a target population, and for our lifespan 
+extension drugs, this means choosing a population 
+that’s most likely to benefit over the duration of our 
+clinical studies. If approved, our drugs will be intended 
+for use in the same populations studied in the clinical 
+efficacy trials.
+Our goal is to help as many dogs as possible, and we 
+hope to pursue additional research to expand access to 
+a broader population in the future.
+Why develop both an injection and daily pill to 
+treat overexpression of growth hormone in 
+large dogs?
+Our goal is to offer a range of options to suit the needs 
+of veterinarians and dog owners. 
+An injectable formulation offers convenience and 
+improved compliance, while a daily pill may be preferred 
+by some owners.
+What about cats?
+We love them too, but don’t currently have any plans to 
+develop therapies for cats.
+Sources
+1 Lawler DF, Larson BT, Ballam JM, Smith GK, Biery DN, Evans RH, Greeley EH, Segre M, Stowe HD, Kealy RD. Diet restriction and ageing in the dog: 
+major observations over two decades. Br J Nutr. 2008 Apr;99(4):793-805. doi: 10.1017/S0007114507871686. Epub 2007 Dec 6. Erratum in: Br J Nutr. 
+2009 Apr;101(7):1112. PMID: 18062831.
+2 Kealy, R.D., Lawler, D.F., Ballam, J.M., Lust, G., Smith, G.K., Biery, D.N., & Olsson, S.E. (1997). Five-year longitudinal study on limited food consumption 
+and development of osteoarthritis in coxofemoral joints of dogs. Journal of the American Veterinary Medical Association, 210(2), 222-225.
+3 López-Otín C, Blasco MA, Partridge L, Serrano M, Kroemer G. Hallmarks of aging: An expanding universe. Cell. 2023 Jan 19;186(2):243-278. 
+doi: 10.1016/j.cell.2022.11.001. Epub 2023 Jan 3. PMID: 36599349.
+Loyal product brief for veterinarians — August 2024
+Q&A

sources/web/petage-third-efficacy-acceptance.txt

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+Just a moment...

sources/web/yahoo-loyal-safety-acceptance.txt

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+Loyal Receives FDA Acceptance of Safety Package for Senior Dog Lifespan Extension Drug 
+
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+ Loyal Receives FDA Acceptance of Safety Package for Senior Dog Lifespan Extension Drug
+
+ Business Wire 
+ January 13, 2026 3 min read 
+
+ Pioneering canine longevity company advances lead lifespan extension drug towards approval with acceptance of the Target Animal Safety section from the FDA's Center for Veterinary Medicine 
+ SAN FRANCISCO, January 13, 2026 --( BUSINESS WIRE )-- Loyal , a clinical-stage animal health company developing lifespan extension drugs for dogs, announced today that the FDA's Center for Veterinary Medicine (CVM) has accepted the Target Animal Safety (TAS) technical section of its conditional approval application for LOY-002, the company's lead drug program to extend the healthy lifespan of senior dogs. 
+
+ With the Reasonable Expectation of Effectiveness (RXE) and TAS sections now complete, LOY-002 has earned FDA-acceptance for two of three major technical sections required for market launch. 
+ "Since founding Loyal six years ago, my goal has always been to get the first drug FDA approved for lifespan extension. This safety acceptance brings us very close to achieving that vision," said Loyal Founder and CEO Celine Halioua. "We are well on our way to bringing the first dog longevity drugs to market." 
+ The First Longevity Drug for Dogs 
+ LOY-002, a prescription daily pill, aims to extend the healthy lifespan of senior dogs and maintain their quality of life as they age by proactively targeting the underlying metabolic drivers of aging and delaying the onset of disease. If approved, LOY-002 stands to be the first FDA-approved drug for lifespan extension itself in any species. 
+ Acceptance of both TAS and RXE are strong advances in Loyal's pursuit of FDA Expanded Conditional Approval (XCA) , a new regulatory pathway that allows innovative therapies that fill unmet medical needs to come to market sooner. The FDA's acceptance of LOY-002's TAS submission represents the first known safety acceptance for a lifespan extension drug from the FDA. 
+
+ As part of the TAS package, Loyal submitted scientific evidence from multiple studies to support LOY-002's safety profile. This included a standard safety study as well as additional field safety data from over 400 dogs on LOY-002 from the program's pivotal effectiveness trial, the STAY study. The FDA has agreed that LOY-002's data supports its safety for the proposed conditions of use. 
+ "As a veterinarian, what I care about most, especially when it involves preventive care, is safety," said Dr. Ellen Ratcliff, Loyal's VP of Clinical and Veterinary Medicine. "The FDA's sign off on this submission is an important vote of confidence in our mission to develop safe and effective lifespan extension drugs for dogs." 
+
+ Story Continues 
+ TAS completion follows on several milestones for LOY-002 in the past year, including the FDA's acceptance of RXE in February 2025. Loyal also completed enrollment for LOY-002's pivotal efficacy trial, the STAY study, in July 2025. At 1,300 dogs across 70 veterinary clinics, it's the largest clinical trial in the history of veterinary medicine. Loyal expects to complete the final major technical section and apply for XCA next year. 
+
+ About Loyal 
+ Loyal is an animal health company developing the first drugs intended to help dogs live longer, healthier lives. With over $150M raised to date, Loyal hopes to extend the lifespan of dogs and improve their quality of life by targeting the underlying mechanisms of aging. Loyal's work builds on decades of research, and their team of experts in dog health and longevity is dedicated to furthering this research and developing better ways to quantify and improve the aging process in dogs. It currently has three drugs in development and is making progress toward approval from the FDA's Center for Veterinary Medicine. 
+ For more information, please visit loyal.com . 
+ View source version on businesswire.com: https://www.businesswire.com/news/home/20260113476778/en/ 
+ Contacts 
+ Press Contact: 
+Isabelle Wood
+Communications Manager
+415-320-6360
+ press@loyal.com 
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