Antiaging pill for dogs clears key FDA hurdle

SAN FRANCISCO – Dog owners do many things to keep their companions happy and healthy. They could soon add an antiaging pill to their pooch’s regimen of walks, vet visits and belly rubs.

Loyal, a biotech start-up based in San Francisco, said Wednesday that a drug it developed to increase canine lifespan has passed a significant milestone on the way to regulatory approval.

The Food and Drug Administration certified the daily pill as having a “reasonable expectation of effectiveness” at extending senior dogs’ lifespans.

The regulator’s Center for Veterinary Medicine still has to certify that the drug is safe and that Loyal can manufacture it at scale before vets can prescribe the pill to dogs 10 years or older that weigh 14 pounds or more.

Loyal’s CEO, Celine Halioua, estimates that the process should be complete by the end of 2025 and called the FDA’s initial recognition “a key step” to extending dogs’ lives.

The Center for Veterinary Medicine recently experienced staff cuts related to the U.S. DOGE Service, but Loyal said it hasn’t heard of any impacts to the team involved. The FDA did not respond to a request for comment.

In the past decade, a subculture of tech entrepreneurship has focused on helping people stave off death, hawking custom-made dietary supplements and $2,500 full-body MRIs and investing in the development of antiaging drugs, among many other efforts.

According to data firm Pitchbook, about $900 million in venture capital has been poured into antiaging and longevity start-ups in the past 12 months.

Loyal has raised more than $150 million in venture funding since its 2019 founding to develop lifespan-extending drugs initially focused on canines.

Launching veterinary drugs is in some ways easier than winning approval for human treatments. Because dogs and humans have evolved alongside one another, Halioua hopes to eventually apply her findings about pets to help prolong their owners’ lives.

“If we can successfully delay the onset and severity of age-related diseases in dogs, it’s extremely compelling evidence that it will also do that in humans,” Halioua said. The biological processes of aging unfold faster in dogs because they live such short lives, she said, helping researchers and entrepreneurs probe how they work.

Loyal aims to launch its pill under an FDA clearance for animal drugs called conditional approval. It allows a company to start selling a treatment that the agency has said is safe and reasonably expected to work, and then to gather additional data to fully prove its effectiveness while it’s on the market.

Loyal is conducting clinical studies, with dogs receiving either genuine or placebo pills – both are beef flavored.

Pets have a huge place in their owners’ lives and pocketbooks. A 2023 survey from the Pew Research Center found that 62% of Americans own a pet and that 97% of owners consider them part of their family.

Dogs are the most common American pet, with 49% of owners having at least one. According to a recent MarketWatch analysis of data from the Bureau of Labor Statistics, Americans spent an average of $876 a year on their pets in 2023, a 90% increase since 2013.

While the drug’s cost to consumers is yet to be determined, Halioua said in a Zoom interview that she wants to make Loyal’s treatment accessible to as many dogs as possible, ideally for less than $100 per month.

“My goal is that every eligible dog is on a longevity drug for them to be healthy longer,” Halioua said, adding that she prefers to aim for mass adoption over “jacking up the price and getting the millionaire dogs on the drug.”

A key hurdle in developing the drug, Halioua said, was coming up with a formula that kept dogs and their owners happy.

The pet food company Purina found in the 1990s that caloric restriction in Labradors extended their lifespan nearly two years and delayed their incidence of osteoarthritis and cancer, “but nobody wants to calorically restrict their dogs,” Halioua said, because doing so can harm the delicate bond between a pet and their owner.

Loyal previously received a “reasonable expectation of effectiveness” certification from the FDA for a longevity drug for large and giant breeds like Great Danes and Newfoundlands. But that treatment has to be administered via injection and will take longer to manufacture and get to market.

Other companies are working to develop weight-loss drugs akin to Ozempic for dogs and cats. Loyal’s pill is a result of research into how to mimic the life-extending benefit of caloric restriction without the appetite suppression – and without the need for an owner to restrict their dog’s food.

The drug aims to improve a dog’s metabolic fitness, or the body’s ability to convert nutrients into energy and regulate hormones, which declines in humans and canines with age.

“We coevolved with dogs, and we domesticated dogs,” Halioua said, “in part because we would feed dogs the scraps … of our food meals in exchange for them protecting us from the other wild animals thousands and thousands of years ago.” As if to underscore the point, Pixie, an 8-year-old Jack Russell terrier on the couch next to Halioua, begged for a treat as she spoke.

Deborah Kado, co-director of the Stanford Center on Longevity and a longtime dog mom, said in a phone interview Tuesday that although the idea of a pet popping a pill to live longer is attractive to owners, unforeseen problems can occur with new drugs that are still in testing. She prefers to feed her dogs healthy food and give them lots of activity and socialization rather than lean on pharmaceuticals.

Besides, Kado said, with so many rescue dogs in need of owners, she discourages holding on longer than fate would naturally determine. One of the many things she loves about dogs is their ability to live in the moment.

“When they get close to the end, they accept it,” said Kado, who has bid farewell to several dogs over the years. “And in a way, that I think makes it easier for humans actually. Endings are going to happen.”

Shaina Denny – mom to Poppy, a miniature dachshund, and founder of Dogdrop, a pet-care start-up that provides doggy day care and builds and licenses software for such businesses – sees firsthand how eager consumers are to invest in their pets’ wellness.

She estimates that pet trends are about 10 years behind human ones. It used to be “niche” to feed a dog raw and/or fresh food, Denny said in a phone interview Monday. But owners are now realizing, “I can’t just feed my dog burnt dog kibble,” she said, and flocking to high-end brands like the Farmer’s Dog.

Denny is also seeing about half of her clients drop off their dogs not for a full day of care but for just a couple of hours while they do something else, like go to the gym.

She takes that as evidence people want to make sure their dog gets mental stimulation, socialization and enrichment – similar to how they might care for a child. At Dogdrop, fluffy clients are challenged with brain puzzles, such as balls with treats hidden inside, and taken on “sniffaris,” in which Fido has to follow his or her nose to be mentally as well as physically challenged.

Denny said humans’ obsession with longevity is now “following onto dogs.”

There’s evidence for that well beyond the dog park. In early 2024, writer-director Lee Sung Jin ended his Emmy acceptance speech by saying: “Everything I do is for my three dogs, so the (FDA), if you could please fast-track that canine antiaging pill, that would be so lovely.”