The First New Smoking Cessation Drug in 20 Years Reaches Its FDA Decision Date in Five Weeks

Cytisinicline, a plant-derived alkaloid that has been used as a smoking cessation aid in Eastern Europe for decades under the brand name Tabex, is now five weeks from its U.S. Food and Drug Administration decision. The FDA’s Prescription Drug User Fee Act target action date is June 20, 2026. If approved, cytisinicline would be the first new medication for smoking cessation introduced in the United States in twenty years — since varenicline (Chantix) in 2006.

The drug works on the same nicotinic acetylcholine receptors as varenicline, but with a tighter binding selectivity that, in recent pharmacology work, is associated with substantially lower rates of nausea than varenicline produces. Across the ORCA-2 and ORCA-3 Phase 3 trials, more than 2,000 participants demonstrated abstinence rates significantly higher than placebo at the 12-week endpoint.

The vaping-cessation angle

Separately — and this is the part most people in addiction medicine are watching closely — Achieve Life Sciences has received an FDA Commissioner’s National Priority Voucher for cytisinicline’s use specifically in vaping/e-cigarette cessation. There is no FDA-approved medication on the market today indicated for quitting vaping. Given the climb in pouch and vape use among adolescents — and the Zyn marketing investigation FDA opened in March 2026 — the existence of an approvable vape-cessation pharmacology may be more strategically significant than the cigarette indication.

Why this matters for people in recovery

Nicotine is the substance use disorder most people in recovery from anything else still have. A new tool is, on its own terms, a good thing. Two notes for anyone watching the June 20 date: the FDA PDUFA target is a target, not a guarantee, and an approval is not a marketing or insurance-coverage event. If you’re thinking about quitting, the 988 Lifeline, the 1-800-QUIT-NOW network, and a conversation with your primary care provider are open today.

Need help right now?

• Quit cigarettes or vape: 1-800-QUIT-NOW (free, confidential, 24/7)
• 988 Suicide & Crisis Lifeline
• Find treatment: Rize Recovery