FDA Accepts Safety Review for First Dog Lifespan Extension Drug

A biotech company’s bid to slow aging in dogs has cleared a historic regulatory hurdle, signaling a shift in how aging itself is treated as a medical problem.

Loyal’s LOY-002 has cleared the FDA’s Target Animal Safety (TAS) review, the first step toward conditional approval for lifespan extension in senior dogs. The drug targets age-related metabolic changes to slow biological aging, not treat specific diseases.

Over 400 dogs have been evaluated in the STAY study, part of a larger clinical trial involving 1,300 dogs across 70 veterinary clinics.

Dr. Ellen Ratcliff said:

"The FDA’s sign off on this submission is an important vote of confidence in our mission to develop safe and effective lifespan extension drugs for dogs."

Celine Halioua said:

"Since founding Loyal six years ago, my goal has always been to get the first drug FDA approved for lifespan extension."

LOY-002 is intended for dogs aged 10+ years and weighs ≥14 pounds. The FDA’s Expanded Conditional Approval (XCA) pathway will be pursued after manufacturing review, with full approval pending completion of the STAY study.

⚠️ LEGAL DISCLAIMER: It is for informational purposes only. It never substitutes for professional medical advice, diagnosis, or treatment. Always consult your doctor regarding any questions about your health.