This story has been updated to clarify the status of LOY-001’s application for conditional approval from the FDA.
(NewsNation) — In a significant step toward potentially extending the lifespan of large- and giant-breed dogs, a San Francisco-based company, Loyal, is working towards conditional approval from the Food and Drug Administration (FDA) for its drug called LOY-001.
The drug, designed to address the shorter lifespans of larger breeds, is anticipated to hit the market as early as 2026, pending FDA approval of Loyal’s manufacturing and safety data.
“Loyal was founded with the ambitious goal of developing the first drugs to extend healthy lifespan in dogs,” said Loyal 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.”
Large- and giant-breed dogs often face lifespans that are significantly shorter than their smaller counterparts, with breeds like Great Danes and Newfoundlands living only seven to eight years compared to the average 20-year lifespan of Chihuahuas and Miniature Poodles.
The key factor contributing to this discrepancy is the elevated levels of the growth-promoting hormone IGF-1 in larger dogs. Loyal’s LOY-001 aims to address this issue by reducing IGF-1 in adult dogs.
The drug is designed as a long-acting product to be administered by veterinarians every three to six months. Once officially approved by the FDA, dogs over the age of 7 and weighing more than 40 pounds may be eligible for LOY-001 shots.
While conditional approval is a positive step, Loyal must still conduct a series of complex studies to gather definitive efficacy data and meet the FDA’s stringent manufacturing and safety criteria.
The conditional approval is valid for up to five years, during which Loyal will work to complete the necessary data collection and apply for full approval.
If successful, LOY-001 could revolutionize the way pet owners care for their larger canine companions, offering the promise of an extended and healthier life for their beloved pets.