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Last Updated: December 31, 2025

CLINICAL TRIALS PROFILE FOR CYTISINICLINE


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Clinical Trials for Cytisinicline

Trial ID Title Status Sponsor Phase Summary
NCT03848208 ↗ A Single Dose-escalation Study of Cytisine in Adult Smokers Completed Achieve Life Sciences Phase 1 The objectives of this study are: 1. To assess the tolerability and safety of cytisine as a single oral dose. 2. To define the Cmax levels associated to the occurrence of dose-limiting adverse events.
NCT04576949 ↗ A Study of Cytisinicline for Smoking Cessation in Adult Smokers Active, not recruiting Achieve Life Sciences Phase 3 This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline TID for treatment duration of 42 days/6 weeks as well as repeating that duration for a total of 84 days/12 weeks treatment.
NCT05206370 ↗ A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers Not yet recruiting Achieve Life Sciences Phase 3 This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline TID for treatment duration of 42 days/6 weeks as well as repeating that duration for a total of 84 days/12 weeks treatment.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Cytisinicline

Condition Name

Condition Name
Intervention Trials
Smoking Cessation 7
Vaping 1
Vaping Cessation 1
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Condition MeSH

Condition MeSH
Intervention Trials
Smoking Cessation 2
Cigarette Smoking 1
Renal Insufficiency 1
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Clinical Trial Locations for Cytisinicline

Trials by Country

Trials by Country
Location Trials
United States 44
Portugal 5
Spain 1
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Trials by US State

Trials by US State
Location Trials
New York 3
Tennessee 3
Nevada 2
Missouri 2
Massachusetts 2
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Clinical Trial Progress for Cytisinicline

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase Trials
PHASE3 1
PHASE2 1
Phase 3 2
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Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase Trials
Not yet recruiting 4
Completed 2
ACTIVE_NOT_RECRUITING 1
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Clinical Trial Sponsors for Cytisinicline

Sponsor Name

Sponsor Name
Sponsor Trials
Achieve Life Sciences 8
University of California, Los Angeles 1
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Sponsor Type

Sponsor Type
Sponsor Trials
Industry 8
OTHER 1
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