Oveporexton (TAK-861) PDUFA Date (Takeda)
FDA PDUFA decision date for Oveporexton (TAK-861) is September 1, 2026. Developed by Takeda. Indication: Narcolepsy Type 1. Current status: Verifying.
Indication
Narcolepsy Type 1
Notes
Orexin agonist for narcolepsy. Q3 2026 PDUFA — exact date TBD.
Regulatory details
- Company: Takeda
- Therapeutic area: Neurology / CNS
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-09-01
- Outcome: Pending