FDA Kicks Off Review of Takeda's Narcolepsy Hopeful

FDA kicks off review of Takeda's narcolepsy hopeful

The FDA has started a priority review of Takeda's oveporexton for sleep disorder narcolepsy, setting up a decision in the third quarter of the year

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 10, 2026-

FDA Accepts New Drug Application for Orexin Agonist Oveporexton in Narcolepsy Type 1, Grants Priority Review | NeurologyLive - Clinical Neurology News and Neurology Expert Insights

The FDA has granted priority review to Takeda’s new drug application for oveporexton, an orexin receptor 2-selective agonist, for narcolepsy type 1, with a PDUFA date in the third quarter of 2026.

NDA Accepted and Priority Review Granted: Oveporexton for Narcolepsy Type 1

FDA grants priority review to Takeda’s orexin agonist oveporexton, promising phase 3 gains in wakefulness and cataplexy for narcolepsy type 1.