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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR VARENICLINE TARTRATE


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All Clinical Trials for Varenicline Tartrate

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.
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.
NCT00282984 ↗ Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking Completed Pfizer Phase 3 2006-02-01 The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.
NCT00285012 ↗ Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD). Completed Pfizer Phase 3 2006-05-01 This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Varenicline Tartrate

Condition Name

Condition Name for Varenicline Tartrate
Intervention Trials
Smoking Cessation 24
Smoking 3
Schizophrenia 2
Tobacco Dependence 2
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Condition MeSH

Condition MeSH for Varenicline Tartrate
Intervention Trials
Tobacco Use Disorder 4
Schizophrenia 3
Alcoholism 2
Problem Behavior 2
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Clinical Trial Locations for Varenicline Tartrate

Trials by Country

Trials by Country for Varenicline Tartrate
Location Trials
United States 172
South Africa 21
Canada 16
Mexico 16
Brazil 13
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Trials by US State

Trials by US State for Varenicline Tartrate
Location Trials
Massachusetts 11
California 10
Connecticut 9
Pennsylvania 9
Texas 8
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Clinical Trial Progress for Varenicline Tartrate

Clinical Trial Phase

Clinical Trial Phase for Varenicline Tartrate
Clinical Trial Phase Trials
Phase 4 10
Phase 3 11
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Varenicline Tartrate
Clinical Trial Phase Trials
Completed 33
Active, not recruiting 2
Not yet recruiting 2
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Clinical Trial Sponsors for Varenicline Tartrate

Sponsor Name

Sponsor Name for Varenicline Tartrate
Sponsor Trials
Pfizer 25
University of Kansas Medical Center 2
Mayo Clinic 2
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Sponsor Type

Sponsor Type for Varenicline Tartrate
Sponsor Trials
Industry 28
Other 16
NIH 4
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Varenicline Tartrate: Clinical Trials, Market Analysis, and Projections

Introduction to Varenicline Tartrate

Varenicline tartrate, commonly known by the brand name Chantix or Champix, is a prescription medication designed to help individuals quit smoking. It works by binding to nicotine receptors in the brain, reducing cravings and the pleasurable effects of smoking, thereby making it easier to quit[2][3].

Clinical Trials and Efficacy

Long-Term Efficacy in Inpatient Settings

A significant clinical trial, known as the STOP trial, evaluated the long-term efficacy of varenicline tartrate combined with Quitline counseling in an inpatient setting. The study involved 392 adult patients admitted to hospitals with smoking-related illnesses. Participants were randomized to receive either 12 weeks of varenicline tartrate plus Quitline counseling or Quitline counseling alone. The results showed that at 104 weeks, the proportion of participants who remained continuously abstinent was significantly higher in the varenicline tartrate plus counseling group (29.2%) compared to those receiving counseling alone (18.8%)[1].

Combination Therapy with Nicotine Patch

Another study explored the effectiveness of combining varenicline tartrate with nicotine patches for smoking cessation, particularly among heavy drinkers. This combination treatment was found to improve smoking cessation outcomes, with a lower likelihood of relapse compared to placebo. However, participants in the varenicline group experienced more adverse effects, leading to medication discontinuation in some cases[4].

Safety and Adverse Events

Clinical trials have also focused on the safety profile of varenicline tartrate. While the medication is generally well-tolerated, common adverse events include nausea, headache, insomnia, and abnormal dreams. The STOP trial noted that adverse events during the treatment period were lower than those reported in outpatient studies, although mortality rates were similar between the treatment and control groups due to the underlying health conditions of the participants[1][3].

Market Analysis

Current Market Size and Growth

The global varenicline tartrate market has seen significant growth in recent years, driven by increasing awareness of smoking-related health risks and robust healthcare infrastructure in developed regions. The market size was valued at $1.6 billion in 2023 and is expected to grow to $1.7 billion in 2024, with a compound annual growth rate (CAGR) of 6.1%[5].

Regional Market Dynamics

North America and Europe currently dominate the varenicline tartrate market due to strong healthcare systems and high awareness of smoking risks. However, the Asia-Pacific region is anticipated to experience the fastest growth rate in the coming years, driven by increasing awareness and improving healthcare infrastructure[2].

Market Segmentation

The varenicline tartrate market is segmented by type (0.5 mg and 1 mg tablets), route of administration (oral, sublingual, transdermal), patient type (smokers, ex-smokers, pre-quitters), and application (hospital, drug store). This segmentation highlights the diverse needs and preferences of the target market[5].

Market Projections

Future Growth and Trends

The global varenicline tartrate market is projected to reach $2.17 billion by 2028, with a CAGR of 6.3%. Key drivers of this growth include advancements in smoking cessation research, expansion into emerging markets, integration with digital health solutions, government support, and an increased focus on personalized medicine[5].

Innovations and Developments

Recent trends in the market include the development of new formulations such as extended-release tablets and combination therapies that integrate varenicline with other supportive treatments. Strategic partnerships between pharmaceutical companies and the integration of digital health tools with smoking cessation programs are also notable trends[2].

Investment Opportunities

The growing demand for smoking cessation treatments presents a favorable environment for investment. Funding for research and development, expansion into emerging markets, and support for innovative formulations and delivery methods are key investment opportunities in the varenicline tartrate market[2].

Challenges and Considerations

Competition and Accessibility

Despite the positive growth trajectory, the varenicline tartrate market faces challenges such as competition from other cessation products and accessibility issues. These factors can impact market penetration and patient compliance[2].

Side Effects and Safety Concerns

While varenicline tartrate is generally safe, it is associated with certain side effects, including nausea, headache, and insomnia. Patients should be advised to use caution when driving or operating machinery until they know how quitting smoking and/or varenicline may affect them[3].

Key Takeaways

  • Efficacy: Varenicline tartrate, especially when combined with counseling, has shown superior efficacy in long-term smoking cessation.
  • Market Growth: The global market is expected to grow significantly, driven by increasing awareness of smoking risks and advancements in healthcare.
  • Regional Dynamics: North America and Europe currently lead the market, but the Asia-Pacific region is expected to see the fastest growth.
  • Innovations: New formulations and integration with digital health tools are key trends.
  • Investment Opportunities: Funding for R&D, expansion into emerging markets, and support for innovative formulations are promising investment areas.

FAQs

Q1: What is varenicline tartrate and how does it work?

Varenicline tartrate is a prescription medication that helps individuals quit smoking by binding to nicotine receptors in the brain, reducing cravings and the pleasurable effects of smoking.

Q2: What are the common adverse events associated with varenicline tartrate?

Common adverse events include nausea, headache, insomnia, and abnormal dreams. These are generally mild to moderate and occur in the first week of therapy.

Q3: How effective is varenicline tartrate in long-term smoking cessation?

Clinical trials have shown that varenicline tartrate, especially when combined with counseling, is highly effective in achieving long-term smoking cessation, with a significant proportion of participants remaining abstinent at 104 weeks.

Q4: What are the key drivers of the varenicline tartrate market growth?

Key drivers include increasing awareness of smoking-related health risks, advancements in smoking cessation research, expansion into emerging markets, and integration with digital health solutions.

Q5: What are the investment opportunities in the varenicline tartrate market?

Investment opportunities include funding for research and development, expansion into emerging markets, and support for innovative formulations and delivery methods.

Sources

  1. PLOS ONE: "Two-year efficacy of varenicline tartrate and counselling for inpatient smoking cessation" - April 29, 2020
  2. Market Research Intellect: "Global Push to Quit Smoking Drives Expansion of the Varenicline Tartrate Market" - November 14, 2024
  3. Medsafe: "CHAMPIX (varenicline, as tartrate) 0.5 mg and 1 mg film-coated tablets"
  4. JAMA Network Open: "Effect of Combination Treatment With Varenicline and Nicotine Patch on Smoking Cessation" - March 4, 2022
  5. The Business Research Company: "Varenicline Global Market Report 2024"

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