Resolves YES if, before January 1, 2028 (US Eastern), the FDA Center for Veterinary Medicine grants conditional approval, expanded conditional approval, or full approval to any new animal drug whose labeled indication includes extending lifespan, healthy lifespan, or healthspan, or delaying age-related decline, in dogs, as shown by an entry in Animal Drugs @ FDA / the FDA Green Book, an FDA announcement, or the drug's FDA-approved labeling. Acceptance of a technical section (RXE, TAS, CMC) alone does not count. Otherwise NO. Background: The FDA's expanded conditional approval pathway (GFI #261, 2021) lets a drug with a reasonable expectation of effectiveness be marketed while the pivotal study completes. Loyal's LOY-001 received the first reasonable-expectation-of-effectiveness (RXE) acceptance for a lifespan-extension drug in November 2023. LOY-002, a daily pill for dogs aged 10+ weighing 14 lb or more, had its RXE section accepted in February 2025 and its target-animal-safety section accepted on January 13, 2026; the company says the manufacturing section is in progress and anticipates the final technical section being reviewed in 2027. The pivotal STAY study enrolled 1,300 dogs at 70 US practices (completed July 2025) for up to four years. Sources: CVM Guidance for Industry #261 https://dvm360.com/view/fda-determines-drug-for-lifespan-extension-in-large-dogs-to-have-a-reasonable-expectation-of-effectiveness https://loyal.com/posts/loy-002-tas https://loyal.com/stay https://w0lph.github.io/k9/trials/
Where it stands: LOY-002's effectiveness (RXE) section was accepted in February 2025 and its safety (TAS) section on 13 January 2026; the manufacturing section is the one outstanding, and Loyal says it expects that review in 2027. Under expanded conditional approval the drug can be marketed before the STAY study completes. Record with sources: https://w0lph.github.io/k9/trials/loyal-stay-loy-002.html