LOY-001: A Promising Anti-aging Drug for Dogs

On average, large and giant breed dogs are expected to live about half that of miniature and small breeds. What we wouldn’t give to extend our dogs’ lives. Recognizing this need, Loyal, a clinical-stage veterinary medicine company, has developed LOY-001, a longevity drug designed to increase the lifespans of large and giant breeds. The drug is not close to being approved for use; however, the company has received the US Federal Drug Administration’s (FDA) nod to continue research and clinical trials. Reaching the first milestone with a green light provides hope for the future.

Extending longevity in large and giant dog breeds

Dog health and wellness has come a long way. Still, what if there was a medication to extend the lives of our furry friends? We all want our dogs to outlive us, but that's usually not the case. Especially for those who love larger breeds like Labradors, Dobermans, Rottweilers, Irish Wolfhounds, German Shepherds, and Mastiffs (like Bullmastiffs, Dogue de Bordeaux, and Cane Corsos), it's known that their lifespan might be only 5 to 12 years.

Genetics and breed size

Thanks to numerous improvements in veterinary medicine over the past 20+ years, even the largest breed can live well over 10 years with great veterinary care. Pet longevity through modern medicine continues to improve. However, genetics dictates our canine friends’ overall size and lifespan and impacts their overall health.

Dog breeds range from barely a few pounds to over 200 (from healthy to morbidly obese body weights). This variability in breeds is greater than what we see in other species. It has resulted from years of human intervention through breeding trends and other factors. The size of a breed is dictated by their genetic makeup. Researchers have discovered a limited set of genes responsible for over half of the variance in dog breed body sizes.

But a dog's genetics impacts more than just its size. Our canine friend’s overall health, appearance, and exterior characteristics like color, disposition, and lifespan are genetically influenced. The larger the breed, the smaller the lifespan, or to say it another way, the smaller the breed, the more longevity is expected.

Why do larger breeds age faster?

With different sizes come different health conditions that negatively impact dogs as they age. Certain cancers and musculoskeletal issues (joints/bones) occur more commonly in our large/giant breeds, and they even get different types of heart disease more commonly than smaller breeds.

So, why do large breeds age faster? That is part of what Loyalty is trying to determine. Much of aging is still not fully understood genetically. However, Loyalty is putting what we do know to work.

What is LOY-001?

Based on current research results, LOY-001, a potential new drug produced by Loyal (Cellular Longevity, Inc.), has proven to the FDA that they have proof-of-concept and have started pilot studies to hopefully reach conditional FDA approval by 2026. This drug hopes to target key components contributing to aging and even prevent or delay the onset of old-age-associated disease. Thus, they are trying to prevent rather than treat a disease.

By quantifying and controlling the mechanisms of pathological aging, we hope to delay the onset & reduce the severity of age-related diseases. More, healthier years.

Loyal

How LOY-001 works

LOY-001 is an injectable medication that targets a growth hormone, IGF-1 (insulin-like growth factor 1). Research indicates that bigger dog breeds tend to have higher IGF-1 levels, while smaller breeds have lower concentrations. Studies on animals like worms and rodents and a human aging study found that IGF-1 levels are linked to negative changes associated with aging and the overall lifespan potential of animals and humans.

If approved, this pet longevity medication can be administered to large and giant breed dogs by a licensed veterinarian as an injection every 3–6 months. More details on the specific injection recommendations have not been made public yet. The promise is to extend the pet’s expected lifespan and lessen the risk of common health consequences as the pet ages.

Is LOY-001 FDA-approved?

Don’t go running to your vet. Even if the FDA approves LOY-001, it won’t be close to coming to market until 2026. Nonetheless, the FDA has noted that Loyalty has demonstrated "a reasonable expectation of the drug’s effectiveness to extend canine lifespan and health span." This is the first milestone in ensuring that LOY-001 becomes FDA-approved for dogs in the future.

They must first perform testing to demonstrate effectiveness and safety in pursuit of conditional approval and to get permission to continue with product development and clinical trials.

Drug approval is a long and rigorous process. For animal drugs, conditional approval is feasible when a drug class is new, there is no available treatment or preventative for the concept of interest, in this case, pet longevity, and when certain conditions are met. The general course runs from establishing a proof-of-concept, ensuring the reasonable expectation of benefit, conducting clinical trials, and demonstrating effectiveness and safety. Then conditional approval is reached. During that time, for up to five years, the product can be used by licensed veterinarians while continuing to gather additional data on side effects and effectiveness. If the drug's benefits outweigh the harm and improve longevity, the FDA can fully approve the drug for use after five years of conditional approval.

What we don't yet know about LOY-001

Because this drug (not a supplement) is still in development, there are a lot of unanswered questions. Because data is still being collected, many aspects are still uncertain, including:

  • Side effects immediately after use
  • Long-term risks or complications
  • Risks of use with current medications
  • Risks of use with supplements, e.g., joint support products, fish oils
  • Risk of use with underlying disease processes, e.g., genetic disorders
  • Effectiveness in decreasing the risk of common diseases, e.g., certain cancers and joint/bone issues
  • Cost-effectiveness for the average pet owner

If the data shows effectiveness and proves to the FDA that this drug does not only do as proposed but does it with minimal side effects, then conditional approval may be granted. When something is approved conditionally, many people will seize the opportunity to use it immediately.

On the other hand, some might want to hold off until after other people have used it to observe if there are any additional side effects, complications, drug interactions, changes in bloodwork, or other parameters that alter as more data becomes available. So, even once it has achieved conditional approval, not all veterinarians may offer the product.

Loyalty to longevity: hope for the future

Considering the potential, LOY-001 sounds promising. Nonetheless, we must remember that it is just in the early stages of development, and it may prove ineffective in clinical trials; it may have too many side effects, or the company may not be able to show that the benefits outweigh the risks.

For the public to see this drug come to fruition, it will need to obtain FDA approval. Loyal has a long road ahead, but there is hope for large and giant breed dog lovers that they may be able to keep their pets with them for much longer. How it will impact a dog’s life is yet to be seen. Hopefully, soon, we will have great news for dog lovers, breeders, pet parents, and veterinarians alike. As soon as 2026, LOY-001 may make history by becoming the first FDA-approved longevity drug for dogs.

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