News Related to Oveporexton

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FDA Accepts Takeda's Oveporexton NDA, Grants Priority Review for Narcolepsy Type 1

Mar 20, 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.

FDA Grants Priority Review to Takeda's Oveporexton for Narcolepsy Type 1

May 03, 2025

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.