Cytisinicline

Smoking cessation

Manufacturer: Achieve Life Sciences
Regulatory submission: NDA resubmission planned for the fourth quarter of 2026
Launch: Anticipated after potential approval in the first half of 2027
Last updated: September 19, 2026

Section

Product information and disease description Place of product in therapy Approaches to treatment

Heterogeneity of treatment effect

1 evidence topic · 1 source

History of cancer: sponsor-reported pooled ORCA-2 and ORCA-3 analysis

Treatment	Quoted abstinence rate
Cytisinicline for 12 weeks	“24.4%”
Placebo	“15.8%”