Chantix

(varenicline)

ApprovedSmall molecule

Varenicline is used to help people quit smoking by reducing cravings and withdrawal symptoms, and by blocking the rewarding effects of nicotine if someone relapses.[2] Chantix is currently approved and in use across 38 indications[4].[1]

Chantix is one of 779 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

243

Total Trials

Active Trials

778

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Methamphetamine DependenceActive, not recruiting

Nicotine DependenceRecruiting

Psychiatric DisorderActive, not recruiting

Lung CancerApproved

Cognitive ImpairmentActive, not recruiting

Attention Deficit Hyperactivity DisorderActive, not recruiting

Friedreich AtaxiaApproved

Acute Coronary SyndromeActive, not recruiting

Coronary Artery DiseasePreclinical

Active, not recruiting

Cardiovascular DiseasePhase 3

Active, not recruiting

Methamphetamine DependencePhase 2

Active, not recruiting

Nicotine DependenceApproved

Recruiting

Psychiatric DisorderApproved

Active, not recruiting

Lung CancerApproved

Approved

Cognitive ImpairmentPhase 2

Active, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Active, not recruiting

Friedreich AtaxiaApproved

Approved

Acute Coronary SyndromePhase 3

Active, not recruiting

Showing 10 of 37 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Chantix

PPrism Pharmaceuticals

Approved

1 2

Trodelvy

Gilead

Preclinical

37 3

Avastin

Prolia

14 5

MS Contin

Merck & Co.

Preclinical

2 6

Voltaren

Novartis

Preclinical

1 7

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 8

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 9

Zinecard

CChildren's Oncology Group

Preclinical

2 10

Effexor

WWyeth-Lederle Vaccines

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Recruiting

Tobacco Cessation

NCT05786547

Phase 2Recruiting

Alcohol Use Disorder

NCT06006143

Phase 3Recruiting

Tobacco Use

NCT04176172

Q1 2027

Phase 2Recruiting

Parkinson Disease

NCT06679374

N/ARecruiting

Trial

NCT05642715

Q3 2027

Phase 2/3Recruiting

Smoking Cessation

NCT05413122

Clinical

Trials by Indication[1]

Smoking Cessation51 trials

Bupropion Hydrochloride or Patient's Choice for Smoking Cessation in Patients With Squamous Cell Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy

Terminated·WWake Forest University Health Sciences·Phase 1·NCT02582008·9 enrolled

Smoking Cessation Intervention in Respiratory Inpatients

Completed·—·Phase 4·NCT02922387·101 enrolled

Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

Completed·RRoswell Park Cancer Institute·N/A·NCT01771627·300 enrolled

Show 48 more trials

Concurrent Bupropion / Varenicline for Smoking Cessation

Completed·—·Phase 3·NCT01303861·702 enrolled

Extended Treatment for Smoking Cessation

Completed·SStanford University·Phase 4·NCT01330043·223 enrolled

Do Treatments for Smoking Cessation Affect Alcohol Drinking?

Completed·YYale University·Phase 2·NCT00580645·60 enrolled

A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery

Completed· Pfizer logo

Pfizer·Phase 4·NCT00889720·16 enrolled

Deep rTMS and Varenicline for Smoking Cessation

Completed·CCentre for Addiction and Mental Health·N/A·NCT04083144·50 enrolled

Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

Completed· Pfizer logo

Pfizer·Phase 4·NCT00691483·659 enrolled

Combining Varenicline and Naltrexone for Smoking Cessation

Completed·UUniversity of California, Los Angeles·Phase 2·NCT02698215·165 enrolled

Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

Completed·—·N/A·NCT01378858·100 enrolled

Endothelial Function and Autonomic Regulation After Short-term Smoking Cessation: Varenicline Versus Placebo

Terminated·MMayo Clinic·N/A·NCT00673595·19 enrolled

Reward Sensitivity and Pharmacotherapy for Smoking Cessation

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 4·NCT02162849·204 enrolled

Improving Adherence to Smoking Cessation Medication Among PLWHA

Completed·NNYU Langone Health·N/A·NCT01898195·158 enrolled

Optimizing Smoking Cessation for People With HIV/AIDS Who Smoke

Completed·UUniversity of Maryland, Baltimore·Phase 3·NCT02460900·184 enrolled

Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts

Completed·CCentre for Addiction and Mental Health·Phase 4·NCT01023659·893 enrolled

Smoking Cessation Intervention for Thoracic Patients

Completed·MMassachusetts General Hospital·Phase 1/2·NCT00580398·49 enrolled

An Alternative Dosing Schedule of Varenicline for Smoking Cessation

Completed·RRoswell Park Cancer Institute·Phase 2·NCT00835900·60 enrolled

Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: (DIASMOKE)

Completed·UUniversita degli Studi di Catania·N/A·NCT01387425·300 enrolled

Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients

Completed· Pfizer logo

Pfizer··NCT00794365·330 enrolled

Varenicline and Bupropion for Smoking Cessation

Completed·MMayo Clinic·Phase 2/3·NCT00935818·506 enrolled

Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder

Completed·KK.N. Roy Chengappa·Phase 4·NCT01010204·60 enrolled

Smoking Cessation Treatment for Head & Neck Cancer Patients

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT01098955·51 enrolled

Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting

Completed·UUniversity of Zagreb·Phase 3·NCT04015414·352 enrolled

Long-term Varenicline Treatment for Smoking Cessation

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT00828113·101 enrolled

Evaluating Smoking Cessation Interventions for PWH in South Africa

Recruiting·JJohns Hopkins University·Phase 2/3·NCT05413122·660 enrolled

Genetically Informed Smoking Cessation Trial

Completed·WWashington University School of Medicine·Phase 4·NCT02351167·822 enrolled

New Approaches to Smoking Cessation in Heavy Drinkers

Completed·YYale University·Phase 1·NCT02151591·26 enrolled

Varenicline for "Gradual" vs. "Abrupt" Smoking Cessation in Low-motivated COPD Smokers

Unknown status·SShaare Zedek Medical Center·Phase 4·NCT02894957·250 enrolled

Metabolism-informed Care for Smoking Cessation

Completed·VVanderbilt University Medical Center·N/A·NCT03227679·82 enrolled

UW-CTRI Triple Medication Smoking Cessation Study

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT02681510·36 enrolled

Effects of Chantix on Relapse Prevention for Smoking Cessation

Completed·UUniversity of Pennsylvania·Phase 4·NCT00948649·62 enrolled

Varenicline and Smoking Cessation in Schizophrenia

Completed·UUniversity of Minnesota·Phase 2·NCT01111149·24 enrolled

A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation

Completed· Pfizer logo

Pfizer·Phase 3·NCT00141167·250 enrolled

Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Patients After ACS

Unknown status·SSheba Medical Center·N/A·NCT02106637·300 enrolled

Methadone Maintenance Treatment and Smoking Cessation

Unknown status·VVancouver Coastal Health·Phase 2·NCT00906386·112 enrolled

Smoking Cessation Treatment for Methadone Maintenance Patients

Completed·—·Phase 4·NCT01027754·112 enrolled

A Smoking Cessation Intervention for Yale Dining Employees

Completed·YYale University·Phase 4·NCT02562521·25 enrolled

Smoking Cessation Program in the Preadmission Clinic

Unknown status·UUniversity Health Network, Toronto·Phase 4·NCT00937508·290 enrolled

Combining Varenicline and Bupropion for Smoking Cessation

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00943618·641 enrolled

Sympathovagal Balance in Smoking Cessation

Completed·IInstitut fuer anwendungsorientierte Forschung und klinische Studien GmbH·Phase 4·NCT01474265·85 enrolled

Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy

Completed·CClaudio Mendes Pannuti·N/A·NCT02744417·63 enrolled

Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial

Recruiting·MM.D. Anderson Cancer Center·Phase 4·NCT04604509·2,010 enrolled

Smoking Habits and Smoking Cessation in Young Adults

Completed·TTuula Toljamo·Phase 2/3·NCT01531049·300 enrolled

Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression

Completed· Pfizer logo

Pfizer·Phase 4·NCT01078298·525 enrolled

Pre to Postoperative Smoking Cessation

Terminated·JJohns Hopkins University·Phase 2·NCT02683161·5 enrolled

Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

Completed·MMedical University of South Carolina·Phase 2·NCT00664755·140 enrolled

What Are the Effects of Varenicline Compared With Nicotine Replacement Therapy on Long Term Smoking Cessation and Clinically Important Outcomes?

Unknown status·UUniversity of Bristol··NCT02681848·180,000 enrolled

Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease

Completed·OOttawa Heart Institute Research Corporation·Phase 4·NCT00959972·50 enrolled

Varenicline and Combined NRT for Smoking Cessation

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 4·NCT02271919·631 enrolled

Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates

Recruiting·—·Phase 4·NCT03495024·10 enrolled

Smoking18 trials

Wellness Intervention for Smoking and HIV

Recruiting·UUniversity of Arizona·N/A·NCT04725617·200 enrolled

Botswana Smoking and Abstinence Reinforcement Trial

Enrolling by invitation·UUniversity of Maryland, Baltimore·Phase 4·NCT05694637·750 enrolled

Varenicline Light Smoking Pilot

Completed·—·Phase 4·NCT04089982·11 enrolled

Show 15 more trials

Pharmacogenetics, Emotional Reactivity and Smoking

Completed·MM.D. Anderson Cancer Center·Phase 2/3·NCT00507728·646 enrolled

Effects of Varenicline on Smoking Reminders

Completed·UUniversity of Pennsylvania·Phase 2·NCT01524627·124 enrolled

ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking

Completed· Pfizer logo

Pfizer··NCT00808015·1,373 enrolled

The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior

Completed·YYale University·Phase 2·NCT00580853·62 enrolled

Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

Completed·HH. Lee Moffitt Cancer Center and Research Institute·N/A·NCT00747643·163 enrolled

PRecision Interventions for SMoking in the SCCS

Completed·VVanderbilt University Medical Center·Phase 2/3·NCT03521141·67 enrolled

The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse

Completed·YYale University·Phase 2·NCT00773422·30 enrolled

EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking

Completed·SState University of New York at Buffalo·Phase 3·NCT03262662·320 enrolled

"VIBRATIONS" - A Study In Smokers Who Are Willing And Motivated To Stop Smoking With The Aid Of Varenicline Which Will Be Prescribed According To Usual Clinical Practice In Germany

Completed· Pfizer logo

Pfizer··NCT01104636·1,177 enrolled

Effects of Smoking Environments on Craving and Smoking (CameraCue2.0)

Completed·—·N/A·NCT02551692·125 enrolled

Effect of Varenicline on Reactivity to Smoking and Drinking Cues

Completed·CCentre for Addiction and Mental Health·N/A·NCT00873535·48 enrolled

Varenicline Observational Investigation In The Cessation of Smoking

Completed· Pfizer logo

Pfizer··NCT00669240·567 enrolled

Maintaining Nonsmoking

Completed·UUniversity of California, San Francisco·Phase 3·NCT01162239·216 enrolled

Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors.

Completed·—·Phase 4·NCT06029907·19 enrolled

Varenicline Tartrate With Telephone-Based Counseling and/or Internet-Based Counseling in Helping Adults Stop Smoking

Completed·SSRI International·N/A·NCT00301145·1,200 enrolled

Schizophrenia9 trials

Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)

Withdrawn·UUniversity of British Columbia·Phase 4·NCT00702793

Study of the Effects of Mecamylamine and Varenicline in Schizophrenia

Completed·MMassachusetts General Hospital·N/A·NCT00455650·89 enrolled

Effects of Varenicline on Smoking Lapse in Smokers With and Without Schizophrenia

Completed·CCentre for Addiction and Mental Health·Phase 4·NCT01850953·28 enrolled

Show 6 more trials

Effects of Varenicline on Plasticity in Schizophrenia

Completed·CCentre for Addiction and Mental Health·Phase 2·NCT01934023·24 enrolled

Effect of Varenicline on Cognitive Function in Cigarette Smokers With Schizophrenia

Completed·CCentre for Addiction and Mental Health·Phase 2·NCT01093365·58 enrolled

Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

Terminated·—·Phase 2·NCT03507127·5 enrolled

Varenicline Adjunctive Treatment in Schizophrenia

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT00492349·91 enrolled

Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia

Completed·SState University of New York - Upstate Medical University·Phase 4·NCT00727103·10 enrolled

Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors

Completed·NNathan Kline Institute for Psychiatric Research·Phase 4·NCT00802919·93 enrolled

Treatment8 trials

Varenicline in Drug Treatment

Completed·CCentre for Addiction and Mental Health·Phase 4·NCT01286584·33 enrolled

A Study of Varenicline in the Treatment of Visceral Sensation

Completed·MMayo Clinic·Phase 1·NCT06854406·8 enrolled

Treatment of Smoking Among Individuals With PTSD

Completed·UUniversity of Pennsylvania·Phase 2·NCT00937235·142 enrolled

Show 5 more trials

Cannabis-Tobacco Co-Use Treatment Study

Recruiting·MMedical University of South Carolina·Phase 3·NCT06883162·200 enrolled

Extended Varenicline Treatment for Smoking Among Cancer Patients

Completed·UUniversity of Pennsylvania·Phase 3·NCT01756885·207 enrolled

Varenicline Treatment for Active Alcoholic Smokers

Completed·MMayo Clinic·Phase 2/3·NCT01347112·33 enrolled

Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

Completed·—·N/A·NCT00790569·315 enrolled

Tobacco Treatment Comparison for Cancer Care

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT06218823·52 enrolled

Smokers8 trials

Understanding Disparities in Quitting in African American and White Smokers

Completed·—·Phase 4·NCT01836276·449 enrolled

Human Laboratory Study Of Varenicline in Smokers

Completed·UUniversity of Minnesota·N/A·NCT00709696·7 enrolled

The Effect of Varenicline on D2/D3 Receptor Binding in Smokers

Completed·CCentre for Addiction and Mental Health·N/A·NCT01632189·8 enrolled

Show 5 more trials

Varenicline Effects In Schizophrenic Smokers

Completed·NNathan Kline Institute for Psychiatric Research·Phase 4·NCT00548470·14 enrolled

Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Completed·RRutgers, The State University of New Jersey·N/A·NCT01308736·73 enrolled

Financial Incentives for Homeless Smokers: A Community-based RCT

Completed·MMassachusetts General Hospital·N/A·NCT04445662·184 enrolled

Varenicline for Light Smokers

Completed·MMayo Clinic·Phase 4·NCT01639560·93 enrolled

Varenicline + Prazosin for Heavy Drinking Smokers

Completed·YYale University·Phase 1·NCT02193256·5 enrolled

72 more indications

Alcohol Dependence6 trials

Varenicline For Smokers In Recovery From Alcohol Dependence

Completed·MMayo Clinic·Phase 2/3·NCT01092702·32 enrolled

Varenicline (Chantix™) for the Treatment of Alcohol Dependence

Completed·UUniversity of Pennsylvania·Phase 2·NCT00705523·40 enrolled

Varenicline for Alcohol Dependence

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT01146613·200 enrolled

Show 3 more trials

A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence

Completed·UUniversity of California, San Francisco·N/A·NCT01011907·99 enrolled

Varenicline Treatment of Alcohol Dependence in Smokers

Completed·YYale University·Phase 2·NCT01553136·131 enrolled

Varenicline for Alcohol Dependence

Unknown status·JJohannes Gutenberg University Mainz·Phase 2·NCT01071187·40 enrolled

Smokeless Tobacco3 trials

Treating Smokeless Tobacco Use in Rural Veterans

Unknown status·MMark Vander Weg·N/A·NCT02994082·123 enrolled

Varenicline for the Treatment of Smokeless Tobacco

Completed·MMayo Clinic·N/A·NCT00813917·76 enrolled

Efficacy of Varenicline for Smokeless Tobacco Use in India

Completed·UUniversity of Pennsylvania·Phase 2·NCT01098305·237 enrolled

Effectiveness3 trials

Effectiveness of Varenicline: Testing Individual Differences

Completed·TThe Mind Research Network·Phase 4·NCT01228175·218 enrolled

Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)

Terminated·UUniversity of Oklahoma·Phase 2·NCT03722966·34 enrolled

A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT01553084·1,086 enrolled

Tobacco3 trials

Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study)

Completed·QQueen Mary University of London·Phase 3·NCT01184664·117 enrolled

Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction

Completed·RRose Research Center, LLC·Phase 2/3·NCT04210180·25 enrolled

Studying Partial-agonists for Ethanol and Tobacco Elimination in Russians With HIV (St PETER HIV)

Completed·—·Phase 2/3·NCT02797587·400 enrolled

Methamphetamine Dependence3 trials

Varenicline vs Placebo for the Treatment of Methamphetamine Dependence

Completed·UUniversity of California, Los Angeles·Phase 2·NCT01011829·20 enrolled

Varenicline for Methamphetamine Dependence

Completed·UUniversity of California, Los Angeles·Phase 2·NCT01365819·52 enrolled

Varenicline as a Treatment for Methamphetamine Dependence

Completed·—·Phase 1·NCT01571167·17 enrolled

Opioid Dependence2 trials

Smoking Cessation & Opioid Dependence Treatment Integration

Completed·WWest Virginia University·Phase 2/3·NCT02854800·74 enrolled

Pilot Study of Varenicline to Treat Opioid Dependence

Completed·MMayo Clinic·Phase 1·NCT01436474·21 enrolled

Cocaine Dependence2 trials

A Phase II Trial of Varenicline for the Treatment of Cocaine Dependence

Completed·UUniversity of Pennsylvania·Phase 2·NCT01680887·156 enrolled

Chantix for Treating Cocaine Dependence

Completed·UUniversity of Pennsylvania·Phase 2·NCT00567008·37 enrolled

Depressed2 trials

Varenicline in Bipolar Depressed Patients

Completed·MMark Frye·N/A·NCT00813800·11 enrolled

Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers

Completed·—·N/A·NCT00525837·18 enrolled

Cognition2 trials

Varenicline on Reward Responses and Cognition in Adolescent Smokers

Completed·YYale University·Phase 1·NCT01624428·16 enrolled

Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease

Completed· Pfizer logo

Pfizer·Phase 2·NCT00744978·66 enrolled

Cognitive impairment2 trials

Effect of Varenicline on Tobacco Addiction and on Abstinence-induced Cognitive Impairment

Withdrawn·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT01309685

A 6-Week Multicenter Trial Of Varenicline Tartrate For Cognitive Impairment In Subjects With Schizophrenia

Withdrawn· Pfizer logo

Pfizer·Phase 2·NCT00743847

Weight Gain2 trials

Addressing Post Cessation Weight Gain

Terminated·MMayo Clinic·Phase 2/3·NCT02412631·84 enrolled

Lorcaserin for Preventing Weight Gain Among Smokers

Completed·MMayo Clinic·Phase 1/2·NCT02393547·20 enrolled

Parkinson's Disease2 trials

Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Experiments 1 & 2 - Proj #3

Completed·UUniversity of Michigan·Phase 2·NCT02933372·25 enrolled

Crossover Target Engagement Study of Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease (Project #3 - Experiment 3 [UdallP3E3])

Completed·UUniversity of Michigan·Phase 2·NCT04403399·34 enrolled

Parkinson disease2 trials

Reducing Falls With Varenicline in Hypocholinergic Parkinson Disease

Recruiting·VVikas Kotagal·Phase 2·NCT06679374·102 enrolled

Varenicline for Gait and Balance Impairment in Parkinson Disease

Completed·RRush University Medical Center·Phase 2·NCT01341080·40 enrolled

Efficacy and Safety2 trials

A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

Completed· Pfizer logo

Pfizer·Phase 2·NCT00635401·30 enrolled

Efficacy and Safety of Varenicline Among HIV-infected Patients

Completed·AANRS, Emerging Infectious Diseases·Phase 3·NCT00918307·248 enrolled

Prevention2 trials

Relapse Prevention With Varenicline

Completed·JJohns Hopkins University·Phase 4·NCT00944554·104 enrolled

Smoking Relapse Prevention Among COPD Ex-smokers

Terminated·UUniversity of Auckland, New Zealand·Phase 3·NCT02888444·8 enrolled

Tobacco Cessation2 trials

The MATCH (Medication Aids for Tobacco Cessation and Health) Study

Completed·CCentre for Addiction and Mental Health·N/A·NCT02146911·968 enrolled

V+PSF-M for Tobacco Cessation in HIV Care in India

Recruiting·UUniversity of Colorado, Denver·Phase 3·NCT05786547·400 enrolled

Alcohol Use Disorder2 trials

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2

Recruiting·YYale University·Phase 2·NCT06006143·30 enrolled

Human Laboratory Study of Varenicline for Alcohol Use Disorder

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 1/2·NCT03035708·47 enrolled

Cardiovascular Disease2 trials

The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers

Unknown status·OOttawa Hospital Research Institute·Phase 3·NCT01800019·256 enrolled

Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

Completed· Pfizer logo

Pfizer·Phase 3·NCT00282984·714 enrolled

Cannabis Use Disorder2 trials

UH3 Varenicline for Cannabis Use Disorder

Completed·MMedical University of South Carolina·Phase 2·NCT03980561·174 enrolled

Varenicline Treatment for Cannabis Use Disorder

Completed·MMedical University of South Carolina·Phase 2·NCT02892110·72 enrolled

Medication Adherence2 trials

Mobile Health Interventions for Medication Adherence Among PLWH

Withdrawn·—·Phase 4·NCT04191278

Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT03538808·80 enrolled

Asthma1 trial

Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment

Completed·VVibeke Backer·Phase 4·NCT02233231·52 enrolled

Pilot Study1 trial

Pilot Study of Nicotine Nasal Spray and Varenicline on Smoking in Methadone-Maintained Patients

Terminated·UUniversity of Cincinnati·Phase 4·NCT02147132·7 enrolled

Cigarette Smoker1 trial

Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers

Completed·YYale University·Phase 1/2·NCT00502216·40 enrolled

Substance Use Disorders1 trial

Varenicline and Motivational Advice for Smokers With Substance Use Disorders

Completed·—·N/A·NCT00756275·158 enrolled

ESS1 trial

The Avenues Study: Dual Use Cessation

Recruiting·UUniversity of Wisconsin, Madison·Phase 4·NCT06474299·500 enrolled

Withdrawal1 trial

Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal

Withdrawn·VVA Boston Healthcare System·Phase 4·NCT00781755

Breast Cancer1 trial

Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)

Terminated·MMemorial Sloan Kettering Cancer Center··NCT01532232·7 enrolled

Vascular Function1 trial

Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

Unknown status·UUniversity of Athens·Phase 4·NCT02307045·600 enrolled

Complication1 trial

Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

Terminated·AAlliance for Clinical Trials in Oncology·Phase 3·NCT02856581·23 enrolled

Medication1 trial

A Novel Human Lab Model for Screening AUD Medications

Completed·UUniversity of California, Los Angeles·Phase 2·NCT04249882·53 enrolled

Methamphetamine1 trial

Varenicline-Methamphetamine Interaction Study (2008)

Withdrawn·—·Phase 1·NCT00733967

Alcohol Use Disorders1 trial

Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders

Completed·YYale University·Phase 2·NCT01000987·44 enrolled

Labor1 trial

Human Behavioral Pharmacology Laboratory Study of Varenicline's Impact on Cocaine Reinforcement

Withdrawn·JJennifer Plebani·Phase 2·NCT01143857

Mental Illness1 trial

Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

Completed·UUniversity of California, San Diego·Phase 4·NCT04011280·39 enrolled

Antiplatelet1 trial

Influence of Varenicline on the Antiplatelet Action of Clopidogrel

Unknown status·GGeneral Hospital of Chinese Armed Police Forces·N/A·NCT01308671·198 enrolled

AIN1 trial

Effects of Varenicline on Brain Activity During Nicotine Abstinence

Completed·UUniversity of Pennsylvania·N/A·NCT00602927·38 enrolled

Nicotine Dependence1 trial

Varenicline for Nicotine Dependence Among Those With HIV/AIDS

Completed·UUniversity of Pennsylvania·Phase 3·NCT01710137·179 enrolled

Hypertensive1 trial

Smoking Study With Behavioral Therapy for Hypertensive Patients

Completed·UUConn Health·Phase 4·NCT00879177·203 enrolled

Efficacy1 trial

Efficacy of Varenicline in Ambivalent Smokers

Completed·UUniversity of Vermont Medical Center·Phase 2·NCT00595868·220 enrolled

Terminated·MMayo Clinic·Phase 3·NCT01169610·1 enrolled

Interaction1 trial

Varenicline and Nicotine Interactions in Humans (VA)

Completed·YYale University·N/A·NCT00606892·37 enrolled

Alcohol1 trial

Human Behavioral Pharmacology Laboratory (HBPL) Study of Varenicline's Impact on Cocaine and Alcohol Craving

Completed·UUniversity of Pennsylvania·Phase 2·NCT01151813·15 enrolled

Metabolism1 trial

Metabolism Informed Smoking Treatment: The MIST RCT

Completed·VVanderbilt-Ingram Cancer Center·Phase 3·NCT04590404·606 enrolled

Methamphetamine Use1 trial

Dopamine D2/D3 Receptor Upregulation by Varenicline in Methamphetamine Users

Terminated·UUniversity of California, Los Angeles·Phase 1·NCT03059563·62 enrolled

Smoking Behavior1 trial

Measuring Smoking Behaviors While Using Varenicline

Completed·UUniversity of Pennsylvania·Phase 4·NCT00948155·48 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Efficacy of Varenicline on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease

Completed·UUniversity Hospital, Brest·Phase 3·NCT01694732·83 enrolled

Acute Coronary Syndrome1 trial

Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) Trial

Completed·MMark Eisenberg·Phase 3·NCT00794573·302 enrolled

Veterans1 trial

Tailored Tobacco Quitline for Rural Veterans

Completed·IIowa City Veterans Affairs Medical Center·Phase 2·NCT01592695·63 enrolled

Ataxia1 trial

Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia

Terminated·UUniversity of South Florida·Phase 2/3·NCT00803868·28 enrolled

Smoking Reduction1 trial

Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?

Completed·SShaare Zedek Medical Center·Phase 4·NCT02634281·242 enrolled

Lung Cancer1 trial

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

Completed·TThomas Jefferson University·N/A·NCT04694846·19 enrolled

Excessive Daytime Sleepiness1 trial

Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease

Terminated·AAmsterdam UMC, location VUmc·Phase 4·NCT02473562·22 enrolled

Trial1 trial

Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes

Recruiting·MMontefiore Medical Center·N/A·NCT05642715·400 enrolled

Adolescent1 trial

A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers

Completed· Pfizer logo

Pfizer·Phase 1·NCT00463918·73 enrolled

Alcohol Consumption1 trial

Varenicline to Reduce Alcohol Consumption in Heavy Drinkers

Completed·—·Phase 1/2·NCT00695500·50 enrolled

Craving1 trial

Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

Withdrawn·—·N/A·NCT00525928

Vaping Cessation1 trial

Feasibility of Treatment for Vaping Cessation

Withdrawn·MMayo Clinic·Phase 1·NCT04317300

Magnetic Resonance Imaging1 trial

Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers

Completed·MMedical University of South Carolina·N/A·NCT00934024·21 enrolled

Drug1 trial

Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)

Completed· Pfizer logo

Pfizer··NCT00772941·3,939 enrolled

Irritability1 trial

Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo

Completed· Pfizer logo

Pfizer·Phase 4·NCT00749944·110 enrolled

Pregnancy1 trial

Varenicline Pregnancy Cohort Study

Completed· Pfizer logo

Pfizer··NCT01290445·885,185 enrolled

Bipolar Disorder1 trial

A Study of Varenicline for Prevention of Relapse to Smoking in Patients With Schizophrenia or Bipolar Disorder

Completed·MMassachusetts General Hospital·Phase 4·NCT00621777·247 enrolled

Tobacco Use1 trial

Optimizing Tobacco Use Treatment for PLWHA

Recruiting·UUniversity of Pennsylvania·Phase 3·NCT04176172·340 enrolled

Methadone1 trial

Efficacy of Varenicline in Methadone-Stabilized Cocaine Users

Completed·YYale University·N/A·NCT00567320·31 enrolled

Elderly1 trial

Evaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00694044·50 enrolled

E-cigarette Use1 trial

Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use

Recruiting·YYale University·Phase 1·NCT06027840·40 enrolled

Relapse1 trial

Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

Recruiting·YYale University·Phase 2·NCT06609369·114 enrolled

Tobacco Dependence1 trial

Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT02202499·86 enrolled

Safety and Efficacy1 trial

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets

Completed· Pfizer logo

Pfizer··NCT00483002·3,719 enrolled

Unspecified7 trials

Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)

Completed· Pfizer logo

Pfizer··NCT01061710·20 enrolled

Health Systems Reach Interventions Project

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT04199117·210 enrolled

Effects of Varenicline on Cigarette Self Administration

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00731055·16 enrolled

Show 4 more trials

Use of Varenicline for 4-weeks Prior to Quitting

Completed·QQueen Mary University of London·Phase 3·NCT00789074·101 enrolled

Varenicline In-Patient Study

Completed·SStanford University·Phase 2·NCT01413516·17 enrolled

Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users

Unknown status·UUniversity Hospital, Gentofte, Copenhagen·Phase 2/3·NCT00977249·200 enrolled

Tailoring Varenicline to Individual Needs (TVIN Study)

Completed·QQueen Mary University of London·Phase 3·NCT01206010·200 enrolled

Regulatory

FDA Approval Timeline[5]

May 10, 2006

CHANTIX

NDA NDA021928

Oct 15, 2021

TYRVAYA

NDA NDA213978

Sources

References

[1]
ClinicalTrials.gov — 243 trial records for varenicline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Chantix drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — varenicline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for varenicline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213978). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Chantix. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Prism Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Neuronal Acetylcholine Receptor; Alpha4/beta2 Agonist; Alpha4/beta2 Partial Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPrism Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Oct 19, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11224598Oct 19, 2035

10456396Oct 19, 2035

9597284Oct 19, 2035

9532944Oct 19, 2035

9504644Oct 19, 2035

6 more patents

11911380Oct 19, 2035

11903943Oct 19, 2035

11903941Oct 19, 2035

9504645Oct 19, 2035

11903942Oct 19, 2035

12576080Oct 19, 2035

Chantix

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Smoking Cessation51 trials

Smoking18 trials

Schizophrenia9 trials

Treatment8 trials

Smokers8 trials

Alcohol Dependence6 trials

Smokeless Tobacco3 trials

Effectiveness3 trials

Tobacco3 trials

Methamphetamine Dependence3 trials

Opioid Dependence2 trials

Cocaine Dependence2 trials

Depressed2 trials

Cognition2 trials

Cognitive impairment2 trials

Weight Gain2 trials

Parkinson's Disease2 trials

Parkinson disease2 trials

Efficacy and Safety2 trials

Prevention2 trials

Tobacco Cessation2 trials

Alcohol Use Disorder2 trials

Cardiovascular Disease2 trials

Cannabis Use Disorder2 trials

Medication Adherence2 trials

Asthma1 trial

Pilot Study1 trial

Cigarette Smoker1 trial

Substance Use Disorders1 trial

ESS1 trial

Withdrawal1 trial

Breast Cancer1 trial

Vascular Function1 trial

Complication1 trial

Medication1 trial

Methamphetamine1 trial

Alcohol Use Disorders1 trial

Labor1 trial

Mental Illness1 trial

Antiplatelet1 trial

AIN1 trial

Nicotine Dependence1 trial

Hypertensive1 trial

Efficacy1 trial

Tobacco Use Disorder1 trial

Psychiatric Disorder1 trial

Addiction1 trial

Interaction1 trial

Alcohol1 trial

Metabolism1 trial

Methamphetamine Use1 trial

Smoking Behavior1 trial

Chronic Obstructive Pulmonary Disease1 trial

Acute Coronary Syndrome1 trial

Veterans1 trial

Ataxia1 trial

Smoking Reduction1 trial

Lung Cancer1 trial

Excessive Daytime Sleepiness1 trial

Trial1 trial

Adolescent1 trial

Alcohol Consumption1 trial

Craving1 trial

Vaping Cessation1 trial

Magnetic Resonance Imaging1 trial

Drug1 trial

Irritability1 trial

Pregnancy1 trial

Bipolar Disorder1 trial

Tobacco Use1 trial

Methadone1 trial

Elderly1 trial