Cytisinicline PDUFA Date (Achieve Life Sciences)
FDA PDUFA decision date for Cytisinicline is June 20, 2026. Developed by Achieve Life Sciences. Indication: Nicotine dependence / smoking cessation. Current status: Verifying.
Indication
Nicotine dependence / smoking cessation
Notes
Plant-based alkaloid. Breakthrough therapy designation. Large addressable market.
Regulatory details
- Company: Achieve Life Sciences
- Therapeutic area: CNS / Addiction
- Application type: NDA
- Review type: Breakthrough
- PDUFA date: 2026-06-20
- Outcome: Pending