Cytisinicline is a plant-based alkaloid under investigation as the first new therapy for smoking cessation in 20 years, and the first FDA approved therapy for vaping cessation. It received the FDA Commissioner’s National Priority Voucher and Breakthrough Therapy designation.
Manufacturer
Achieve Life Sciences
FDA Approval Date
On June 22, 2026, the Food and Drug Administration issued a Complete Response Letter (CRL) due to manufacturing issues unrelated to the drug’s clinical safety or efficacy. The manufacturer is addressing the issue and plans to resubmit its NDA later this year. Approval is expected in 2027.
Clinical Profile:
Cytisinicline is an oral nicotinic acetyl choline receptor agonist. In trials, it was taken 3mg three times (TID) a day for six weeks or twelve weeks.
Population:
It is estimated that approximately 28.8 million adults smoked cigarettes in the U.S. in 2022.
Pricing and Availability:
Rough estimate of $1,000 to $2,000 for six-week course. Some may require a twelve-week course.
Management Strategy:
If approved this medication would likely be covered as a preventive drug with no out-of-pocket cost for members under ACA guidelines. Utilization management may also be used to differentiate between second-line use for smoking (behind a trial of generic varenicline) and for vaping cessation.
References
IPD Analytics – Cytisinicline for Smoking Cessation, May 2026
Additional Information Press Release
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