Manufacturer
Achieve Life Sciences
FDA Approval Date
CRL 6/22/2026 – Resubmission Pending
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.
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 (Achieve Life Sciences expects 2027 approval), 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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