Cytisinicline
Nicotine Dependence for Smoking Cessation (Combustible Cigarettes)
Key Facts
About Achieve Life Sciences
Achieve Life Sciences is a late-stage specialty pharmaceutical company with a mission to end the global nicotine dependence epidemic. Its strategy is centered on cytisinicline, a plant-based alkaloid with a novel dual agonist/antagonist mechanism for smoking cessation. The company has successfully completed its Phase 3 program, submitted an NDA to the FDA in June 2025, and received a PDUFA target action date of June 20, 2026. If approved, cytisinicline could become the first new FDA-approved treatment in this category in 20 years, targeting a multi-billion dollar market with significant unmet need.
View full company profileAbout Achieve Life Sciences
Achieve Life Sciences is a late-stage specialty pharmaceutical company with a mission to end the global nicotine dependence epidemic. Its strategy is centered on cytisinicline, a plant-based alkaloid with a novel dual agonist/antagonist mechanism for smoking cessation. The company has successfully completed its Phase 3 program, submitted an NDA to the FDA in June 2025, and received a PDUFA target action date of June 20, 2026. If approved, cytisinicline could become the first new FDA-approved treatment in this category in 20 years, targeting a multi-billion dollar market with significant unmet need.
View full company profile