The announcement of a groundbreaking drug by San Francisco biotech company Loyal marks a potential milestone in veterinary medicine. The drug, LOY-001, is on the brink of approval by the U.S. Food and Drug Administration (FDA) for extending the life of large-breed dogs.

According to Loyal’s CEO and founder, Celine Halioua, “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.”

LOY-001 operates by interacting with the hormone IGF-1, which is known to accelerate aging in dogs. Its mechanism is preventative, aiming to curb age-related diseases before they manifest.

Loyal’s statement in a release sent to Fox News Digital emphasizes this innovative approach: “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 drug’s journey towards FDA approval is progressing, with the agency indicating that early data shows potential effectiveness. However, full approval is contingent upon further milestones, including comprehensive clinical trials and safety data reviews. Loyal’s website details the rigorous process thus far, including various studies involving over 450 dogs.

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In a news release, Loyal expressed confidence in the progress, stating, “Today’s milestone is a crucial part of Loyal’s application for conditional approval.”

The release further clarifies, “It means the FDA agrees LOY-001 has a reasonable expectation of effectiveness.”

This phase is critical, as conditional approval allows the marketing of the drug for lifespan extension in target canine populations while additional data is gathered.

Veterinary experts recognize the importance of this development. Dr. Ivana Crnec, a veterinarian with Veterinarians.org, shared her professional opinion with Fox News Digital: “In my professional opinion, the drug is groundbreaking.”

She added, “We still need to wait and see its results and potential side effects, but so far, LOY-001 is definitely promising.”

The optimism is tempered with caution, as expressed by Dr. Jeffrey Krasnoff, a veterinarian at Brookville Animal Hospital. He told Fox News Digital, “It sounds too good to be true,” reflecting a desire for more research despite the potential benefits.

“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,” he continued.

LOY-001, which is administered by injection every three to six months, is also being developed as a daily pill. The drug is expected to be available by 2026, contingent upon the FDA’s approval of Loyal’s manufacturing and safety data, opening a new chapter in the health and longevity of large-breed dogs.

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