Loyal Secures $22 Million to Advance Canine Longevity Drug Development

Mar 3

Loyal, a clinical-stage animal health company developing longevity drugs for dogs, has reached a significant regulatory milestone while securing $22 million in Series B-2 funding. The investment, led by Valor Equity Partners and Collaborative Fund, brings Loyal’s total funding to over $150 million.

Regulatory Progress: FDA Acceptance of RXE for LOY-002

The FDA’s Center for Veterinary Medicine (CVM) has accepted the Reasonable Expectation of Effectiveness (RXE)section of Loyal’s conditional approval application for LOY-002, a daily flavored tablet designed to extend the lifespan and improve the quality of life for senior dogs aged 10 and older, weighing at least 14 pounds.

This marks Loyal’s second RXE approval, following a prior FDA acceptance for a longevity drug targeting large-breed dogs. RXE acceptance indicates that Loyal’s data supports the potential effectiveness of LOY-002 in extending canine lifespan, a key step toward conditional FDA approval.

How LOY-002 Works

LOY-002 targets metabolic dysfunction, a key mechanism of aging, and aims to:

Reduce age-related diseases that impact senior dogs' quality of life.
Offer an alternative to caloric restriction, a known longevity intervention.
Provide a practical, daily treatment to support healthy aging.

Loyal expects to complete the necessary manufacturing and safety requirements for Expanded Conditional Approval (XCA) by the end of the year.

STAY Study: The Largest Longevity Trial in Veterinary History

Loyal’s STAY study, the first FDA-concurred clinical trial for longevity, is a four-year pivotal efficacy trial for LOY-002. Since its launch in December 2023, the study has:

Enrolled over 1,000 dogs from 70 veterinary clinics nationwide.
Become the largest veterinary clinical trial in history.
Focused on proving LOY-002’s ability to extend lifespan and improve health outcomes.

Industry Reactions and Future Outlook

Loyal’s progress has drawn attention from industry leaders and investors:

Celine Halioua, Founder & CEO of Loyal: "Everything we do is in service of helping dogs live longer, healthier lives. RXE acceptance increases the probability that dogs will soon have access to our longevity drugs."
Linda Rhodes, VMD, PhD, Board Member: "Loyal continues to break new regulatory ground in bringing longevity products to market."
Ellen Ratcliff, VP of Clinical & Veterinary Medicine: "Achieving RXE acceptance validates our work and shows confidence from one of the world’s highest-quality regulatory agencies."

As Loyal moves closer to bringing longevity treatments to veterinary medicine, the company is paving the way for a new era in animal health and aging science.