FDA Set to Rule on First New Smoking Cessation Drug in 20 Years: Cytisinicline Decision Due June 20

Cytisinicline, a plant-based alkaloid for smoking cessation, has an FDA PDUFA date of June 20, 2026 — 8 days away. If approved, it would be the first new quit-smoking drug in 20 years. Phase 3 ORCA-2 and ORCA-3 trials showed significantly higher quit rates than placebo.