Cytisinicline FDA Approval Status
Last updated by Judith Stewart, BPharm on June 27, 2025.
FDA Approved: No
Generic name: cytisinicline
Company: Achieve Life Sciences, Inc.
Treatment for: Smoking Cessation
Cytisinicline is a nicotinic acetylcholine receptor partial agonist in development as a treatment of nicotine dependence for smoking cessation in adults.
- Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is thought to work in the treatment of nicotine addiction by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products.
- A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for cytisinicline as a treatment of nicotine dependence for smoking cessation in adults. The NDA is supported by results from the placebo-controlled Phase 3 ORCA-2 and ORCA-3 trials which demonstrated significantly greater abstinence rates by the end of treatment and in long-term abstinence through week 24 compared to placebo.
- Cytisinicline has also been granted Breakthrough Therapy Designation as an aid to nicotine e-cigarette, or vaping, cessation.
Development timeline for cytisinicline
Further information
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