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sources/web/dvm360-stay-enrollment.txt

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+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 
+ 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.
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+ Read more 
+
+ October 1st, 2026 Staying calm under pressure 
+ A technician’s approach to veterinary trauma
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+ Read more 
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+ 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.
+
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+ 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 
+
+ Advertisement
+
+ Advertisement
+
+ Trending on dvm360
+ 1
+
+ Pet Poison Helpline reports rise in Apoquel calls
+
+ 2
+
+ Fungus-contaminated wound product linked to infections in nearly 100 horses, at least 20 euthanized
+
+ 3
+
+ Veterinary Scene Down Under: Australian Veterinary Association membership grows and New South Wales moves to recognize veterinary technicians
+
+ 4
+
+ Researchers document first known cases of Marfan syndrome in domestic cats
+
+ 5
+
+ Saline injection lot recalled after potassium chloride bag found in mislabeled wrap

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 
+
+ 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 
+
+ Advertisement
+
+ Advertisement
+
+ Trending on dvm360
+ 1
+
+ Pet Poison Helpline reports rise in Apoquel calls
+
+ 2
+
+ Fungus-contaminated wound product linked to infections in nearly 100 horses, at least 20 euthanized
+
+ 3
+
+ Veterinary Scene Down Under: Australian Veterinary Association membership grows and New South Wales moves to recognize veterinary technicians
+
+ 4
+
+ Researchers document first known cases of Marfan syndrome in domestic cats
+
+ 5
+
+ Saline injection lot recalled after potassium chloride bag found in mislabeled wrap

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/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/yahoo-loyal-safety-acceptance.txt

@@ -0,0 +1,178 @@
+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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sources/web_index.json

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     "retrieved_at": "2026-10-01T14:23:02+00:00"
   },
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-    "url": "https://www.petage.com/loyal-earns-third-efficacy-acceptance-from-the-fda-for-canine-lifespan-extension/",
-    "status": 403,
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   {
     "slug": "gizmodo-loy-001",
     "url": "https://gizmodo.com/loyal-drug-loy-001-extend-lifespan-giant-dog-breed-fda-1851055513",