CLINICAL TRIALS PROFILE FOR CYTISINICLINE

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.
NCT05431387 ↗	A Study of Cytisinicline for Vaping Cessation in Adult Smokers	Not yet recruiting	Achieve Life Sciences	Phase 2	This placebo-controlled Phase 2 study is being conducted at sites within the United States to evaluate the safety profile of 3 mg cytisinicline administered TID for 12 weeks.
NCT05566288 ↗	Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers	Not yet recruiting	Achieve Life Sciences	Phase 1	The primary objective of this trial is to assess the effects of cytisinicline at therapeutic and supratherapeutic doses on cardiac repolarization relative to placebo in healthy adult subjects who are smokers.
NCT05631938 ↗	Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose	Not yet recruiting	Achieve Life Sciences	Phase 1	The primary objectives of this study are: 1. To obtain information on the pharmacokinetics of cytisinicline following a single oral dose in subjects with varying degrees of renal impairment relative to matched controls with normal renal function. 2. To investigate the extent of cytisinicline removal by hemodialysis.
NCT05981768 ↗	Study to Evaluate Effect of Food on Bioavailability of Single 3 mg Tablet and Pharmacokinetics (PK) of Multiple 3 mg Doses in Healthy Adult Smokers	Completed	Achieve Life Sciences	Phase 1	To assess the effect of food on the bioavailability of 3 mg cytisinicline following single-dose administration, and to evaluate the PK profile of 3 mg cytisinicline TID following multiple days of administration during Days 5-8.

Clinical Trial Conditions for Cytisinicline

Condition Name

Condition Name
Intervention	Trials
Smoking Cessation	7
E-Cig Use	1
Renal Impairment	1
Tobacco Use Disorder	1

Condition MeSH

Condition MeSH
Intervention	Trials
Smoking Cessation	2
Tobacco Use Disorder	1
Cigarette Smoking	1
Renal Insufficiency	1

Clinical Trial Locations for Cytisinicline

Trials by Country

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

Trials by US State

Trials by US State
Location	Trials
Tennessee	3
New York	3
Ohio	2
Virginia	2
Texas	2

Clinical Trial Progress for Cytisinicline

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Cytisinicline

Sponsor Name

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

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	8
OTHER	1