Cytisinicline

DRUG11 trials

Sponsors

Achieve Life Sciences Inc., Achieve Life Sciences, Maimónides Biomedical Research Institute of Córdoba, University of California, Los Angeles

Conditions

E-Cig UseNicotine addictionRenal ImpairmentSmoking CessationTobacco Use DisorderVapingVaping Cessation

Phase 1

A Four Way Crossover Thorough QT/QTc Study to Evaluate the Electrocardiographic Effects of Therapeutic and Supratherapeutic Doses of Cytisinicline in Healthy Smokers

CompletedCTIS2022-500954-40-00

Achieve Life Sciences Inc.Nicotine addiction

Start: 2022-10-17End: 2023-01-06Target: 32Updated: 2022-10-03

Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers

CompletedNCT05566288

Achieve Life SciencesSmoking Cessation

Start: 2022-10-17End: 2022-12-23Updated: 2023-05-18

Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose

CompletedNCT05631938

Achieve Life SciencesRenal Impairment

Start: 2023-01-10End: 2023-09-04Updated: 2025-07-11

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

CompletedNCT05981768

Achieve Life SciencesSmoking Cessation

Start: 2023-08-08End: 2023-09-21Updated: 2023-10-18

Phase 2

A Study of Cytisinicline for Vaping Cessation in Adult Smokers

CompletedNCT05431387

Achieve Life SciencesE-Cig Use, Vaping

Start: 2022-07-13End: 2023-02-28Updated: 2026-01-14

Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity

RecruitingNCT06617312

University of California, Los AngelesSmoking Cessation, Tobacco Use Disorder

Start: 2024-12-05End: 2026-12-31Target: 64Updated: 2025-12-03

Phase 3

A Study of Cytisinicline for Smoking Cessation in Adult Smokers

CompletedNCT04576949

Achieve Life SciencesSmoking Cessation

Start: 2020-10-13End: 2021-12-23Updated: 2026-01-15

A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers

CompletedNCT05206370

Achieve Life SciencesSmoking Cessation

Start: 2022-01-20End: 2023-03-21Updated: 2026-01-14

Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers

CompletedNCT06435221

Achieve Life SciencesSmoking Cessation, Vaping Cessation

Start: 2024-05-28End: 2025-10-06Updated: 2025-11-26

Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes

Not yet recruitingNCT07392125

Achieve Life SciencesVaping Cessation

Start: 2026-05-15End: 2027-09-30Target: 800Updated: 2026-02-06

Phase 4

12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence

Not yet recruitingNCT06579846

Maimónides Biomedical Research Institute of CórdobaSmoking Cessation

Start: 2025-01-01End: 2025-12-31Target: 150Updated: 2024-09-04

Related Papers

Cytisinicline for smoking cessation among patients with a history of cancer: A post-hoc analysis from two phase 3 clinical trials.

Journal of Clinical Oncology2026-05-28

Cytisinicline for smoking cessation in individuals with self-reported COPD: a post hoc analysis of the ORCA-2 and ORCA-3 trials.

2026-01-15

Cytisinicline for Smoking Cessation

JAMA Internal Medicine2025-04-216 citations

Multicentre Pilot Study to Evaluate the Efficacy of Targeted Exercise in Combination with Cytisinicline on Smoking Cessation at 12 Months: MEDSEC-CTA

Healthcare2024-12-12

Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial.

2024-08-0117 citations

Cytisinicline for Smoking Cessation

JAMA2023-07-1165 citations