FDA could greenlight the drug as early as next year

A US-based biotech startup, Loyal, has secured a key approval from the Food and Drug Administration (FDA) for what could be the world’s first drug designed to extend the lifespan of dogs. The FDA’s Center for Veterinary Medicine has accepted the Reasonable Expectation of Effectiveness (RXE) section of its conditional approval application for LOY-002, paving the way for a potential commercial launch by next year, according to The Times.

Loyal secures additional funding for development

Headquartered in San Francisco, Loyal has also raised an additional $22 million in its B-2 funding round from Valor Equity Partners and Collaborative Fund, among others—bringing the company’s total investment to $150 million.

“Everything we do is in service of helping dogs live longer, healthier lives. These two milestones represent our ongoing commitment to that mission through years of diligence and hard work,” said Loyal founder and CEO Celine Halioua.

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“Proving efficacy is one of the most challenging parts of developing a novel drug. While we still have significant work to do, RXE increases the probability that dogs will soon have access to our longevity drugs.”

How soon could the drug be available?

Loyal is currently conducting a multi-year trial involving over 1,000 dogs to evaluate the long-term safety and efficacy of the pill. However, under an accelerated approval pathway, the FDA could authorize the drug’s release as soon as next year—provided Loyal meets specific safety and manufacturing milestones.

According to Loyal, the pill mimics the metabolic benefits of “caloric restriction” or fasting—long known to promote longevity. When the body functions on fewer calories, it metabolizes fuel more efficiently, potentially extending lifespan.

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“Everyone asks me, ‘Is this just Ozempic for dogs?’ And the answer is no,” Halioua clarified.

Why do dogs have shorter lifespans?

Dogs age faster than humans due to their higher metabolic rate, which accelerates biological wear and tear. Researchers working on the study hope to develop a drug that counteracts this process.

While veterinary medicine has made significant strides in recent years, these advancements are still relatively new compared to human medicine. As a result, canine lifespans have not increased at the same rate as human lifespans over the past few centuries.

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