Oveporexton (TAK-861) is an investigational oral orexin receptor 2 selective agonist being developed by Takeda for narcolepsy type 1. It is designed to restore orexin signaling and address the underlying orexin deficiency in NT1. FDA accepted its NDA and granted Priority Review in February 2026, with a PDUFA target action date in the third quarter of 2026.
The FDA accepted Takeda's new drug application for oveporexton, an investigational orexin 2 receptor agonist for narcolepsy type 1, and granted priority review with a PDUFA action date in Q3 2026.
The FDA accepted Takeda's NDA for oveporexton (TAK-861), an oral orexin receptor 2 agonist for narcolepsy type 1, and granted Priority Review with a PDUFA goal date in Q3 2026. The drug could become the first approved orexin agonist.
