Overview
- LOY-002 has cleared two of three FDA safety reviews, with the second accepted in January, positioning the drug for possible conditional approval.
- The STAY trial is enrolling about 1,300 senior dogs at roughly 70 clinics to compare the daily pill with a placebo and track lifespan and health.
- The pill lowers activity of the growth hormone IGF-1 to mimic calorie restriction benefits and is intended for dogs aged 10 and older who weigh at least 14 pounds.
- Regulators reviewed safety data from more than 400 dogs and reported no serious side effects, though long-term benefit is still unproven.
- Loyal says a limited launch could come as early as late 2026 under conditional clearance, with a manufacturing review targeted for 2027 and an expected gain of about one healthy year under study.