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JUN 22 2026
CRL · 99 DAYS AGO

Achieve Life Sciences — cytisinicline $ACHV

for nicotine dependence (smoking cessation)

NDA · Standard Review

About

Nicotine dependence is a chronic, relapsing disease that creates a compulsive craving for tobacco, which is a leading preventable cause of death worldwide. Cytisinicline is a partial agonist that binds to the same brain receptors as nicotine, reducing both cravings and withdrawal symptoms. By mimicking nicotine's calming effect without the same addictive potential, this drug could help people break their dependence and quit smoking.

Pivotal trial

NCT04015414 Phase 3 completed NCT04015414

The overall goals of this study are to 1) assess awareness of interest in the use of pharmacotherapy for smoking cessation in Croatia and Slovenia, countries in Central Europe with very high smoking prevalence, and 2) investigate whether cytisine is at least as feasible and effective as varenicline in helping smokers to quit in a real-life setting: family medicine practices in Croatia and Slovenia. The investigators propose to survey patients from 40 primary care practices (20 in Croatia and ...

Source: ClinicalTrials.gov

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