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Last Updated: December 12, 2024

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.
>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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Varenicline

Condition Name

Condition Name for Varenicline
Intervention Trials
Smoking Cessation 114
Nicotine Dependence 47
Smoking 38
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Condition MeSH

Condition MeSH for Varenicline
Intervention Trials
Tobacco Use Disorder 86
Schizophrenia 19
Alcoholism 18
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Clinical Trial Locations for Varenicline

Trials by Country

Trials by Country for Varenicline
Location Trials
United States 470
Canada 46
China 33
United Kingdom 19
Korea, Republic of 17
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Trials by US State

Trials by US State for Varenicline
Location Trials
Connecticut 33
Pennsylvania 33
California 32
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 83
Phase 3 47
Phase 2/Phase 3 16
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Clinical Trial Status

Clinical Trial Status for Varenicline
Clinical Trial Phase Trials
Completed 204
Recruiting 33
Not yet recruiting 18
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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) 25
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Sponsor Type

Sponsor Type for Varenicline
Sponsor Trials
Other 361
NIH 113
Industry 109
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