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

Study of Varenicline (Champix) for Smoking Cessation/Reduction in Patients With Bipolar Disorder

Not Applicable

Completed

Conditions: Nicotine Dependence

First Posted Date: 2010-03-26

Last Posted Date: 2011-06-23

Lead Sponsor: Centre for Addiction and Mental Health

Target Recruit Count: 30

Registration Number: NCT01093937

Locations: 🇨🇦
Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Effect of Varenicline on Cognitive Function in Cigarette Smokers With Schizophrenia

Phase 2

Completed

Conditions: Schizophrenia
Schizoaffective Disorder

Interventions: Drug: Varenicline

First Posted Date: 2010-03-25

Last Posted Date: 2016-08-26

Lead Sponsor: Centre for Addiction and Mental Health

Target Recruit Count: 58

Registration Number: NCT01093365

Locations: 🇨🇦
Centre for Addiction and Mental Health (33 Russell street), Toronto, Ontario, Canada

Varenicline For Smokers In Recovery From Alcohol Dependence

Phase 2

Completed

Conditions: Tobacco Abstinence

Interventions: Drug: Varenicline

First Posted Date: 2010-03-25

Last Posted Date: 2023-09-25

Lead Sponsor: Mayo Clinic

Target Recruit Count: 32

Registration Number: NCT01092702

Locations: 🇺🇸
Mayo Clinic Nicotine Research Program, Rochester, Minnesota, United States

Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression

Phase 4

Completed

Conditions: Smoking Cessation
Depression

Interventions: Drug: varenicline
Drug: placebo

First Posted Date: 2010-03-02

Last Posted Date: 2013-04-16

Lead Sponsor: Pfizer

Target Recruit Count: 525

Registration Number: NCT01078298

Locations: 🇺🇸
Comprehensive Psychiatric Care, Norwich, Connecticut, United States
🇺🇸
Clinical Neuroscience Solutions Incorporated, Orlando, Florida, United States
🇩🇪
Ludwig Maximilians-Universitaet Muenchen, Muenchen, Germany

and more 35 locations

Varenicline for Alcohol Dependence

Phase 2

Conditions: Alcohol Dependence

Interventions: Drug: Placebo
Drug: Varenicline

First Posted Date: 2010-02-19

Last Posted Date: 2010-09-15

Lead Sponsor: Johannes Gutenberg University Mainz

Target Recruit Count: 40

Registration Number: NCT01071187

Locations: 🇩🇪
Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am Main, Frankfurt am Main, Hessen, Germany
🇩🇪
Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg.university Mainz, Mainz, Rheinland-Pfalz, Germany