Cytisinicline's FDA Decision Is 30 Days Away — and It Could Be the First New Quit-Smoking Drug in Two Decades

The Countdown

The FDA is scheduled to issue its decision on cytisinicline — a treatment for nicotine dependence developed by Achieve Life Sciences — on June 20, 2026. If approved, it will be the first new pharmacological smoking cessation treatment in approximately twenty years, joining varenicline (Chantix) and bupropion SR on the market.

Cytisinicline is derived from cytisine, a plant alkaloid found in laburnum seeds used for decades as a folk quit-smoking remedy in Eastern Europe. It acts as a partial agonist at nicotinic acetylcholine receptors — the same mechanism as varenicline, but with a receptor binding profile that clinical trial data associates with lower rates of nausea. Achieve Life Sciences’ FDA New Drug Application, accepted in June 2025, includes a Breakthrough Therapy designation and a Commissioner’s National Priority Voucher for e-cigarette/vaping cessation.

Why the Bar Is So High

Currently, only 10% of people who attempt to quit smoking each year succeed. Nicotine dependence is among the most biologically entrenched of all substance use disorders. There are currently zero FDA-approved treatments for vaping cessation. Achieve Life Sciences has also initiated a Phase 2 trial evaluating cytisinicline specifically for vaping cessation.

Why This Matters for People in Recovery

Tobacco use disorder kills more people in recovery than the original substance use disorder in many cases. People in opioid, alcohol, and stimulant recovery smoke at rates 2–4 times higher than the general population, yet many treatment programs have historically deferred addressing it. The SAMHSA helpline (1-800-662-4357) also provides tobacco cessation referrals.