‘Groundbreaking’ anti-aging drug for dogs moves closer to gaining FDA approval

A drug that could potentially extend the life of large-breed dogs is closer to being approved by the U.S. Food and Drug Administration (FDA).

That’s according to an announcement last week by the San Francisco biotech company Loyal, the company behind the drug. 

Currently, there are no FDA-approved or conditionally approved animal drugs for this purpose.

“There are 25 million large-breed dogs in the U.S. alone — that’s 25 million dogs we can help live longer, and with better quality of life,” Celine Halioua, CEO and founder of Loyal, said in a statement sent to Fox News Digital.

The company claims the drug LOY-001 may help slow down age-related processes for dogs that are 40 pounds or more. 

The medication works by interacting with a hormone called IGF-1 that accelerates the aging process. It is designed to prevent age-related canine diseases — rather than waiting until symptoms appear, according to a spokesperson for Loyal. 

“Loyal’s approach represents a different paradigm, using our understanding of the underlying mechanisms of aging to reduce the risk of these diseases in the first place,” the company stated in a release sent to Fox News Digital.

Last week, the drugmaker announced that LOY-001 has cleared early hurdles with the FDA, which signaled that the data so far shows the drug’s potential effectiveness. 

More milestones must be met before the drug is fully approved and can hit the market, however. 

Those include the completion of a large clinical trial and a review of safety and manufacturing data. 

Thus far, the four-year process has included interventional studies of LOY-001 in an FDA-accepted model of canine aging and an observational (no-drug) study of 451 dogs, according to Loyal’s website.

“Today’s milestone is a crucial part of Loyal’s application for conditional approval,” the company said in the news release. 

“It means the FDA agrees LOY-001 has a reasonable expectation of effectiveness,” the statement continued. “Once the FDA approves Loyal’s manufacturing and safety data packages, Loyal can market the drug for lifespan extension in the target canine population.”

“Conditional approval lasts for up to five years, during which time Loyal will collect the remaining effectiveness data and apply for full approval.”

The average dog’s lifespan is about 10 to 13 years, with larger breeds aging faster and having an even shorter life expectancy, according to veterinarians who spoke with Fox News Digital.

Some believe that is due to selective breeding, which can enhance a dog’s size and development.

Dr. Ivana Crnec, a veterinarian with the Texas-based foundation Veterinarians.org, told Fox News Digital that body size and growth rate are key factors affecting a dog’s longevity.

The growth-promoting hormone IGF-1 — believed to play a role in accelerating aging and reducing lifespan — has been found at much higher levels in large dogs compared to small-breed dogs.

The new experimental drug targets this growth-promoting hormone to reduce its levels.

“In my professional opinion, the drug is groundbreaking,” said Crnec.

“We still need to wait and see its results and potential side effects, but so far, LOY-001 is definitely promising,” she continued. “The fact that the FDA described the drug as having ‘reasonable expectations of effectiveness’ says a lot about its potential.” (She was not involved in the research.)

By slowing down aging’s effect on vital functions, the drug will “indirectly have a positive impact on the life quality of large and giant dog breeds,” Crnec told Fox News Digital.

Other veterinarians said they were cautiously optimistic.

“It sounds too good to be true,” Dr. Jeffrey Krasnoff, a veterinarian at Brookville Animal Hospital on Long Island, commented to Fox News Digital about the experimental drug.

“I would love to see the research. It would be awesome if it truly made a difference in the longevity of our large canine friends.”

The drug is administered by an injection by a veterinarian every three to six months, but the company is working on a daily pill, according to Loyal’s website. 

LOY-001 is expected to be available in 2026, subject to FDA approval of Loyal’s manufacturing and safety data.