Experimental Drug Aimed at Extending Dogs’ Lifespans Clears ‘Key’ FDA Regulatory Hurdle

An experimental drug that could lengthen the lifespan of larger dogs and keep them healthier later in life may hit the market after clearing a “key FDA regulatory hurdle.”

Loyal for Dogs, a clinical-stage veterinary medicine company, is working on a “medication to help dogs live longer and stay healthier as they age,” their website stated. 

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The company announced Tuesday that the Food and Drug Administration (FDA) Center for Veterinary Medicine has approved the Reasonable Expectation of Effectiveness section of their conditional approval application for the drug, called LOY-001.

This is a “key FDA regulatory hurdle required in the approval process,” Axios reported.

“Loyal was founded with the ambitious goal of developing the first drugs to extend healthy lifespan in dogs,” said founder and CEO Celine Halioua. “This milestone is the result of years of careful work by the team. We’ll continue to work just as diligently to bring this and our other longevity programs through to FDA approval.”

LOY-001 is aimed at extending the lifespans and maintaining the quality of life for large and giant-breed dogs, which can have as little as half the expected lifespan of small breeds.

Experts suspect the reduced lifespan in larger dog breeds is due in part to elevated levels of the growth-promoting hormone IGF-1, caused by selective breeding.

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“Large dogs have up to 28x the levels of IGF-1 as small dogs,” the San Francisco-based biotech company’s press release stated.

Loyal for Dogs claims that the medication works by reducing IGF-1 in adult dogs, thus increasing the lifespan.

The FDA’s decision came after the agency reviewed data submitted by the company, including studies showing LOY-001’s ability to reduce levels of the growth hormone and the “beneficial impact on functional outcomes in dogs,” the statement read.

“The data you provided are sufficient to show that there is a reasonable expectation of effectiveness,” an FDA official said in a letter that Loyal for Dogs shared with the New York Times.

The company’s study on the drug’s effectiveness involved 452 companion dogs of 84 different breeds, aged two to 18.

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“It validated the clinical relevance of the functional outcomes seen in Loyal’s earlier studies,” their press release stated.

The average lifespan for larger dogs is about eight to 12 years, according to the American Kennel Club. 

The average is 10 to 15 years for small breeds — with Chihuahuas living up to a whopping 20 years.

While the drug still has to undergo clinical trials, Loyal for Dogs hopes to gain full FDA approval by 2026.

“We’re going to be going for claiming at least one year of healthy life span extension,” Halioua told the Times. 

The founder and CEO told Axios in August: “We’re not making immortal dogs, to be clear, but that rate of aging will be slower, hopefully, which means the pet will be in a healthier state for longer. And that’s fundamental to all of the biology of what we’re doing.”