Varenicline

Generic Name: Varenicline

Brand Names: Champix, Chantix, Tyrvaya

Drug Type: Small Molecule

Chemical Formula: C_₁₃H_₁₃N_₃

CAS Number: 249296-44-4

Unique Ingredient Identifier: W6HS99O8ZO

Background: Varenicline is a prescription medication used to treat smoking addiction. This medication is the first approved nicotinic receptor partial agonist. Specifically, varenicline is a partial agonist of the alpha4/beta2 subtype of the nicotinic acetylcholine receptor. In addition it acts on alpha3/beta4 and weakly on alpha3beta2 and alpha6-containing receptors. A full agonism was displayed on alpha7-receptors.

On March 9, 2015, the U.S. Food and Drug Administration warned that Varenicline, in the form of Pfizer Inc's quit-smoking drug, Chantix, has been associated with seizures and that some patients who drink while taking the drug may become aggressive or black out. Pfizer is conducting an additional safety study of the drug, results of which are expected in late 2015. The FDA said it is keeping the black box in place at least until the results of the trial are announced.

Indication: For use as an aid in smoking cessation.

Varenicline as a nasal spray is indicated for the symptomatic treatment of dry eye disease.

Associated Conditions: Dry Eye Syndrome (DES)

Associated Therapies: Smoking, Cessation

Clinical Trials

A Clinical Trial to Compare Pharmacokinetics of the "CDFF0318" and "Champix Tab. 1mg"

Phase 1

Completed

Conditions: Smoking Cessation
Pharmacokinetics

Interventions: Drug: CDFF0318, Champix

First Posted Date: 2020-11-17

Last Posted Date: 2020-11-17

Lead Sponsor: CTC Bio, Inc.

Target Recruit Count: 32

Registration Number: NCT04631874

Locations: 🇰🇷
Chungbuk National University Hospital, Cheongju-si, Korea, Republic of

Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial

Phase 4

Recruiting

Conditions: Cigarette Smoking-Related Carcinoma

Interventions: Drug: Nicotine Replacement
Drug: Bupropion Hydrochloride Controlled-release
Other: Questionnaire Administration
Drug: Varenicline
Other: Tobacco Cessation Counseling

First Posted Date: 2020-10-27

Last Posted Date: 2025-04-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 2010

Registration Number: NCT04604509

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents

Phase 4

Terminated

Conditions: Vaping
Nicotine Dependence

Interventions: Drug: Placebo
Drug: Varenicline

First Posted Date: 2020-10-26

Last Posted Date: 2024-04-04

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 5

Registration Number: NCT04602494

Locations: 🇺🇸
Center for Addiction Medicine, Boston, Massachusetts, United States

Metabolism Informed Smoking Treatment: The MIST RCT

Phase 3

Completed

Conditions: Smoking

Interventions: Behavioral: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.
Drug: Nicotine Replacement Therapy
Drug: Varenicline
Other: Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)

First Posted Date: 2020-10-19

Last Posted Date: 2025-05-09

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 608

Registration Number: NCT04590404

Locations: 🇺🇸
Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450, Nashville, Tennessee, United States

STARS (Smoking Treatment And Remote Sampling) Study

Phase 1

Completed

Conditions: Cigarette Smoking
Smoking
Tobacco Smoking
Smoking Cessation

Interventions: Drug: Varenicline 0.5 MG
Drug: Nicotine Replacement Therapy (NRT)

First Posted Date: 2020-08-25

Last Posted Date: 2025-04-24

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 652

Registration Number: NCT04525755

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV

Phase 4

Active, not recruiting

Conditions: Tobacco Use Cessation

Interventions: Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Drug: Varenicline or bupropion
Behavioral: Contingency Management

First Posted Date: 2020-07-28

Last Posted Date: 2025-01-09

Lead Sponsor: Yale University

Target Recruit Count: 320

Registration Number: NCT04490057

Locations: 🇺🇸
SUNY Downstate STAR Clinic, Brooklyn, New York, United States
🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

and more 1 locations