Not just for big dogs! Our senior dog program receives preliminary FDA efficacy acceptance (RXE)
In November 2023, Loyal earned what we believe to be the FDA’s first-ever formal acceptance that a drug can be developed and approved to extend lifespan for large dog lifespan extension.
I am unbelievably excited to share that LOY-002, our program bringing longevity to dogs of almost all sizes, has also earned its formal FDA acceptance for reasonable expectation of efficacy (RXE).
This makes Loyal the likely recipient of both the first- and second-ever RXE acknowledgements from the FDA for longevity drug programs for any species — including humans.
The other two primary FDA requirements needed for conditional approval (and our market launch) are manufacturing and safety. We have extensive data supporting both and hope to have completed all the regulatory requirements by the end of 2025, making an FDA-approved longevity drug a reality for millions of dogs in the next year.
While our team was hard at work on this, we also raised an additional $22M as part of a B-2 funding round, bringing total investment in Loyal to over $150M since founding the company back in 2019. Together, these two milestones demonstrate our strong progress towards realizing the first dog longevity drug.
What this means for senior dogs
Read a vet’s perspective on this milestone ->
All dog owners know the heartache of watching your dog age. It’s difficult not to wonder how much time you have left as their muzzles gray and walks shorten.
At Loyal, our goal is to develop safe and accessible medicines that address the underlying causes of age-related diseases before they impact our dogs’ quality of life. Previous research has shown that this is theoretically possible: in a study from Purina, calorie-restricted dogs lived ~2 years longer than their littermates, with delayed onset of cancer and osteoarthritis.
Dramatic, lifelong caloric restriction isn’t a practical or safe method of extending lifespan and healthspan in dogs long-term — which is why we’re working on an alternate solution. LOY-002 is a caloric restriction mimetic, delivering the benefits of caloric restriction through a pharmaceutical drug, without weight loss or appetite suppression.
Who’s the drug for?
We are pursuing FDA approval for use in dogs 10 years and older and weighing at least 14 lb. Metabolic health declines with age, even in generally healthy dogs, and this has been linked with a worsened quality of life and higher disease burden over time. LOY-002 aims to extend healthy lifespan by mitigating age-associated metabolic dysfunction and related diseases.
This is an issue that vets in our clinical trial, the STAY study, have also raised. Dr. Cat Arthur, the Principal Investigator at Baycrest Veterinary Hospital in St. Petersburg, FL, said, “Before I joined the trial, we were trying to do things to help minimize [dogs’] pain and suffering as they aged, though there aren’t a lot of good options… The thing that tends to excite people the most [about LOY-002] is the possibility that they’re giving their dog something that will keep them around for longer.”
When I think about the potential impact of LOY-002, I imagine a tiny Jack Russell Terrier, who’s still raring to go at 10 and has plenty of cuddles left in him. Or your beloved Pittie-mix, who once had loads of playful energy but, at 13, isn’t picking up tricks like she used to. Or the friendly neighborhood 12-year-old Golden Retriever, who’s generally healthy but isn’t as keen to go on her daily walk as she once was. We want to give dogs more time — whether they’re healthy in their senior years or already showing signs of unhealthy aging.
What is FDA conditional approval?
I have always believed that FDA approval is crucial to demonstrate the scientific legitimacy of longevity drugs. Our drugs are utilizing the conditional approval pathway.
Proving efficacy is one of the most challenging parts of developing a novel drug. While there is still significant work to do, achieving this milestone increases the probability that dog owners will soon have access to a longevity drug. Our board member and my mentor Linda Rhodes, VMD, PhD says it best: “I am excited that we are one step closer to bringing the first-ever longevity treatment for dogs to market.”
How do I sign up to get the drug?
We’re still undergoing the FDA review process for conditional approval, which includes receiving additional acceptances for the remaining technical sections (including manufacturing and safety). Sign up for our mailing list for the latest news on our progress to deliver an FDA-approved longevity drug soon.
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Read a vet’s perspective on this milestone ->
Here’s what the press is saying
The Washington Post --- Antiaging pill for dogs clears key FDA hurdle