San Francisco Company’s Anti-Aging Drug for Dogs Progresses Toward FDA Approval

A drug that may extend the lifespan of large-breed dogs is moving closer to receiving approval from the U.S. Food and Drug Administration (FDA), as announced last week by the San Francisco biotech company Loyal, the drug’s developer. Currently, no FDA-approved or conditionally approved animal drugs serve this purpose.

Celine Halioua, CEO and founder of Loyal highlighted the potential impact, stating, “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.” The company’s drug, LOY-001, is designed to slow down age-related processes in dogs weighing 40 pounds or more. 

The medication works by interacting with a hormone called IGF-1, which accelerates the aging process. Loyal’s approach focuses on preventing age-related canine diseases before symptoms manifest. The company believes this represents a paradigm shift, utilizing an understanding of aging mechanisms to reduce the risk of disorders proactively.

Recent developments indicate that LOY-001 has cleared initial FDA hurdles, demonstrating its potential effectiveness. However, additional milestones must be achieved, including a comprehensive clinical trial and a review of safety and manufacturing data, before the drug can be fully approved and brought to market.

The company’s four-year process has included interventional studies of LOY-001 in an FDA-accepted model of canine aging and an observational study involving 451 dogs. The recent milestone represents a crucial step in Loyal’s application for conditional approval, lasting up to five years. During this period, Loyal will collect the remaining effectiveness data and apply for full approval.

The average lifespan of a dog is approximately 10 to 13 years, with larger breeds aging faster and having a shorter life expectancy. Experts suggest that selective breeding, impacting body size and growth rate, contributes to this phenomenon. The experimental drug targets the growth-promoting hormone IGF-1, found at higher levels in large dogs than in small breeds.

Veterinarians like Dr. Ivana Crnec express optimism about the drug’s potential groundbreaking impact. She notes the FDA’s acknowledgment of LOY-001 having a reasonable expectation of effectiveness. The drug, administered by injection every three to six months, is expected to be available in 2026, pending FDA approval of manufacturing and safety data. Some veterinarians express cautious optimism, while others eagerly await further research to assess the drug’s true impact on the longevity of large canine breeds.