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JUL 3 2026
UPCOMING · 30 DAYS TO PDUFA

Achieve Life Sciences cytisinicline $ACHV

for nicotine dependence (smoking cessation)

NDA · Standard Review

Accepted SEP 3 2025.

About

Nicotine dependence is a chronic condition where the brain craves nicotine despite harmful consequences, leading to withdrawal symptoms and making quitting tobacco extremely difficult. Cytisinicline partially activates the same brain receptors as nicotine, reducing cravings without delivering the addictive substance. This approach may help smokers break their dependence by easing withdrawal while gradually weaning them off nicotine’s effects.

Pivotal trial

ORCA-2 Phase 3 completed NCT04576949

This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline 3 times daily (TID) for treatment duration of 42 days/6 weeks and evaluate 3 mg cytisinicline TID for treatment duration of 84 days/12 weeks.

Source: ClinicalTrials.gov

Also in development