CLINICAL TRIALS PROFILE FOR VARENICLINE

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.

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.

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

Condition MeSH

Condition MeSH for Varenicline
Intervention	Trials
Tobacco Use Disorder	86
Schizophrenia	19
Alcoholism	17
Disease	13

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

Trials by US State

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

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

Clinical Trial Status

Clinical Trial Status for Varenicline
Clinical Trial Phase	Trials
Completed	204
Recruiting	31
Unknown status	15

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

Sponsor Type

Sponsor Type for Varenicline
Sponsor	Trials
Other	351
NIH	110
Industry	108