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

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 in Adult Chinese With Dry Eye Disease

Phase 1

Completed

Conditions: Dry Eye Disease

Interventions: Drug: Varenicline Tartrate Nasal Spray

First Posted Date: 2022-10-12

Last Posted Date: 2023-05-01

Lead Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Target Recruit Count: 9

Registration Number: NCT05576415

Locations: 🇨🇳
Huashan Hospital, Shanghai, China

Varenicline for Treatment of E-cigarette Dependence

Phase 2

Completed

Conditions: Smoking Cessation

Interventions: Drug: Varenicline Tartrate
Drug: Placebo

First Posted Date: 2022-09-15

Last Posted Date: 2024-12-02

Lead Sponsor: Yale University

Target Recruit Count: 40

Registration Number: NCT05541497

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States
🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

A Randomized, Controlled, Double-masked, Investigator-initiated Trial to Evaluate Tear Film Quality and Stability in Subjects With Dry Eye Disease Using OC-01 (Varenicline Solution) Nasal Spray 0.03 mg as Compared to Vehicle Control Nasal Spray

Phase 4

Conditions: Dry Eye Disease

Interventions: Drug: Varenicline solution
Drug: Placebo nasal spray (OC-01 Vehicle Nasal Spray)

First Posted Date: 2022-08-24

Last Posted Date: 2022-08-24

Lead Sponsor: Stephenson Eye Associates

Target Recruit Count: 60

Registration Number: NCT05514041

Locations: 🇺🇸
Stephenson Eye Associates, Venice, Florida, United States

Evaluating Smoking Cessation Interventions for PWH in South Africa

Phase 2

Recruiting

Conditions: Smoking Cessation
Comorbidities and Coexisting Conditions
HIV

Interventions: Drug: Nicotine patch
Drug: Varenicline
Behavioral: Intensive Behavioral Counselling
Drug: Nicotine gum
Behavioral: Peer Counselling

First Posted Date: 2022-06-09

Last Posted Date: 2024-08-09

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 660

Registration Number: NCT05413122

Locations: 🇿🇦
Perinatal HIV Research Unit (PHRU), Soweto, Gauteng, South Africa

Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease

Phase 3

Completed

Conditions: Dry Eye Disease

Interventions: Drug: Varenicline Tartrate Nasal Spray
Drug: Placebo (vehicle)

First Posted Date: 2022-05-18

Last Posted Date: 2023-04-25

Lead Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Target Recruit Count: 340

Registration Number: NCT05378945

Locations: 🇨🇳
Henan Eye Hospital, Zhengzhou, Henan, China
🇨🇳
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
🇨🇳
Peking University Third Hospital, Beijing, Beijing, China

and more 17 locations

Varenicline for Nicotine Vaping Cessation in Adolescents

Phase 4

Completed

Conditions: Vaping
Nicotine Dependence

Interventions: Drug: Double Blind Varenicline
Drug: Double Blind Placebo
Behavioral: QuitVaping
Behavioral: This Is Quitting

First Posted Date: 2022-05-10

Last Posted Date: 2025-04-27

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 261

Registration Number: NCT05367492

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

Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans

Phase 2

Withdrawn

Conditions: Cannabis Use Disorder
Tobacco Use Disorder

Interventions: Drug: Varenicline
Drug: Placebo

First Posted Date: 2022-03-24

Last Posted Date: 2024-08-27

Lead Sponsor: VA Office of Research and Development

Registration Number: NCT05294263

Locations: 🇺🇸
Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina, United States

Wellness Intervention for Smoking and HIV

Not Applicable

Recruiting

Conditions: Smoking Cessation
HIV
Cardiovascular Diseases
Sleep

Interventions: Drug: Varenicline
Behavioral: Smoking Cessation Counseling
Other: Health Approach 2 to Reduce Smoking
Behavioral: Health Approach 1 to Reduce Smoking

First Posted Date: 2021-01-27

Last Posted Date: 2024-02-08

Lead Sponsor: University of Arizona

Target Recruit Count: 200

Registration Number: NCT04725617

Locations: 🇺🇸
Banner University Medical Center Phoenix, Phoenix, Arizona, United States
🇺🇸
University of Arizona, Tucson, Arizona, United States

Effectiveness of an Enhanced Tobacco Intervention Protocol Compared to Standard Treatment in Helping Head and Neck and Lung Cancer Patients Starting Treatment to Reduce Cigarette Use

Not Applicable

Completed

Conditions: Head and Neck Squamous Cell Carcinoma
Lung Non-Small Cell Carcinoma

Interventions: Drug: Nicotine Replacement
Drug: Bupropion Hydrochloride Controlled-release
Other: Quality of Life Assessment
Other: Best Practice
Drug: Varenicline
Other: Tobacco Cessation Counseling
Other: Questionnaire Administration

First Posted Date: 2021-01-05

Last Posted Date: 2025-03-25

Lead Sponsor: Thomas Jefferson University

Target Recruit Count: 19

Registration Number: NCT04694846

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy, Philadelphia, Pennsylvania, United States
🇺🇸
Jefferson Health, Methodist Hospital, Philadelphia, Pennsylvania, United States

Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

Phase 2

Recruiting

Conditions: Cancer, Treatment-Related
Smoking Cessation

Interventions: Drug: Bupropion
Drug: Long-acting nicotine replacement therapy
Drug: Varenicline
Behavioral: High-intensity counseling
Behavioral: Low-intensity counseling
Other: No nicotine replacement therapy
Drug: Nicotine Replacement Products

First Posted Date: 2020-11-18

Last Posted Date: 2024-06-07

Lead Sponsor: Joseph Valentino, MD

Target Recruit Count: 126

Registration Number: NCT04634071

Locations: 🇺🇸
Kings Daughters Medical Center - Ashland, Ashland, Kentucky, United States
🇺🇸
Med Center Health, Bowling Green, Kentucky, United States
🇺🇸
University Of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States

and more 1 locations

Drug Development Updates

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