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JUN 22 2026
CRL · 39 DAYS AGO

Achieve Life Sciences cytisinicline $ACHV

for nicotine dependence (smoking cessation)

NDA · Standard Review

About

Nicotine dependence is a chronic, relapsing disease marked by a compulsive urge to use tobacco despite its harmful health effects, causing millions of preventable deaths each year. Cytisinicline is a partial agonist that activates the same brain receptors as nicotine but with less intensity. By occupying these receptors, it can reduce cravings and withdrawal symptoms, potentially helping people quit smoking.

Pivotal trial

RAUORA Phase 3 completed NCT02957786

To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural support compared to varenicline plus behavioural support for smoking cessation, in indigenous Māori (or family of Māori) who smoke and are motivated to quit.

Source: ClinicalTrials.gov

Also in development