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Last Updated: February 3, 2023

CLINICAL TRIALS PROFILE FOR VARENICLINE


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505(b)(2) Clinical Trials for Varenicline

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting Los Angeles Clinical Trials Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting National Institute on Drug Abuse (NIDA) Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting Pfizer Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting University of Nevada, Reno Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting Arizona State University Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Varenicline

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00141167 ↗ A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation Completed Pfizer Phase 3 2005-02-01 The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo for smoking cessation.
NCT00141206 ↗ A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation Completed Pfizer Phase 3 2003-05-01 The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.
NCT00143286 ↗ A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation Completed Pfizer Phase 3 2003-04-01 The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.
NCT00143299 ↗ A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline Completed Pfizer Phase 3 2003-10-01 The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.
NCT00143325 ↗ An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation Completed Pfizer Phase 3 2005-01-01 Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.
NCT00143364 ↗ A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation Completed Pfizer Phase 3 2003-06-01 The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.
NCT00150241 ↗ A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation Completed Pfizer Phase 2 2000-02-01 The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Varenicline

Condition Name

Condition Name for Varenicline
Intervention Trials
Smoking Cessation 110
Nicotine Dependence 47
Smoking 38
Tobacco Use Disorder 22
[disabled in preview] 0
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Condition MeSH

Condition MeSH for Varenicline
Intervention Trials
Tobacco Use Disorder 86
Schizophrenia 19
Alcoholism 17
Disease 13
[disabled in preview] 0
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Clinical Trial Locations for Varenicline

Trials by Country

Trials by Country for Varenicline
Location Trials
United States 461
Canada 46
China 32
United Kingdom 19
Korea, Republic of 17
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Trials by US State

Trials by US State for Varenicline
Location Trials
Pennsylvania 33
California 32
Connecticut 31
New York 26
Minnesota 25
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Clinical Trial Progress for Varenicline

Clinical Trial Phase

Clinical Trial Phase for Varenicline
Clinical Trial Phase Trials
Phase 4 80
Phase 3 45
Phase 2/Phase 3 16
[disabled in preview] 143
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Clinical Trial Status

Clinical Trial Status for Varenicline
Clinical Trial Phase Trials
Completed 204
Recruiting 31
Unknown status 15
[disabled in preview] 52
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Clinical Trial Sponsors for Varenicline

Sponsor Name

Sponsor Name for Varenicline
Sponsor Trials
Pfizer 87
National Institute on Drug Abuse (NIDA) 53
National Cancer Institute (NCI) 23
[disabled in preview] 61
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Sponsor Type

Sponsor Type for Varenicline
Sponsor Trials
Other 351
NIH 110
Industry 108
[disabled in preview] 14
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