AXS-05 (dextromethorphan-bupropion) PDUFA Date (Axsome Therapeutics)
FDA PDUFA decision date for AXS-05 (dextromethorphan-bupropion) is April 30, 2026. Developed by Axsome Therapeutics. Indication: Alzheimer's disease agitation. Current status: Verifying.
Indication
Alzheimer's disease agitation
Notes
If approved, first drug specifically for Alzheimer's agitation.
Regulatory details
- Company: Axsome Therapeutics
- Therapeutic area: Neurology / CNS
- Application type: NDA
- Review type: Standard
- PDUFA date: 2026-04-30
- Outcome: Pending