Pill coming in 2026 that’s supposed to increase the lifespan of dogs

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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.

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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.

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