In eight days, the FDA could approve the first new smoking cessation drug in 20 years. That is the timeline facing cytisinicline, a plant-based alkaloid developed by Achieve Life Sciences that has completed two successful Phase 3 trials and whose regulatory review concludes with a PDUFA-targeted action date of June 20, 2026.
If approved, cytisinicline would join a short list of FDA-approved pharmacological aids for smoking cessation — bupropion (Wellbutrin/Zyban, approved in 1997 for depression and smoking in 1997 and 2000) and varenicline (Chantix, approved in 2006). That is effectively 20 years during which the FDA-approved toolkit for helping Americans quit tobacco has not grown, even as approximately 28 million adults continue to smoke and tobacco kills nearly half a million Americans every year, costing the U.S. economy an estimated $600 billion annually.
