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 34 indications[4].[1]

Chantix is one of 554 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

246

Total Trials

Active Trials

553

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Nicotine DependenceCompleted

Psychiatric DisorderWithdrawn

Lung CancerApproved

Attention Deficit Hyperactivity DisorderTerminated

Friedreich AtaxiaApproved

Eye DiseaseCompleted

Smoking BehaviorCompleted

Dry Eye SyndromeApproved

Alzheimer DiseaseApproved

Coronary Artery DiseasePreclinical

Active, not recruiting

Nicotine DependenceApproved

Completed

Psychiatric DisorderApproved

Withdrawn

Lung CancerApproved

Approved

Attention Deficit Hyperactivity DisorderApproved

Terminated

Friedreich AtaxiaApproved

Approved

Eye DiseaseApproved

Completed

Smoking BehaviorApproved

Completed

Dry Eye SyndromeApproved

Approved

Alzheimer DiseaseApproved

Approved

Showing 10 of 34 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Chantix

PPrism Pharmaceuticals

Approved

1 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

Duragesic-100

CCephalon

Preclinical

2 8

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 9

Spravato

WWim Janssens

Preclinical

2 10

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Parkinson Disease

NCT06679374

N/ARecruiting

Trial

NCT05642715

Q3 2027

Phase 1Active, not recruiting

Smoking Cessation

NCT01098955

Q4 2027

Post-ApprovalRecruiting

Smoking Cessation

NCT06832085

Q1 2029

Phase 3Recruiting

Treatment

NCT06883162

Clinical

Trials by Indication[1]

Smoking Cessation58 trials

Smoking Cessation Intervention in Respiratory Inpatients

Completed·—·Phase 4·NCT02922387·101 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

Show 55 more trials

Improving Adherence to Smoking Cessation Medication Among PLWHA

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

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

Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

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

Concurrent Bupropion / Varenicline for Smoking Cessation

Completed·—·Phase 3·NCT01303861·702 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

Combining Varenicline and Naltrexone for Smoking Cessation

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

Varenicline and Smoking Cessation in Schizophrenia

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

Effects of Chantix on Relapse Prevention for Smoking Cessation

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

Long-term Varenicline Treatment for Smoking Cessation

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

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

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

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

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

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

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

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 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 Versus Cytisine for Smoking Cessation in Primary Care Setting

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

An Alternative Dosing Schedule of Varenicline for Smoking Cessation

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

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

Recruiting·—·Phase 4·NCT03495024·10 enrolled

Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder

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

Cytisine Versus Varenicline for Smoking Cessation

Completed·UUniversity of Auckland, New Zealand·Phase 3·NCT02957786·679 enrolled

Smoking Cessation Treatment for Head & Neck Cancer Patients

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

Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation

Completed·—·Phase 3·NCT01406223·282 enrolled

Genetically Informed Smoking Cessation Trial

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

Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia

Completed·UUniversity of Maryland, Baltimore·Phase 2·NCT00554840·16 enrolled

Varenicline and Combined NRT for Smoking Cessation

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

Mobile Evidence-Based Smoking Cessation for Veterans Living With HIV (MESH)

Completed·VVA Office of Research and Development·Phase 4·NCT04135937·12 enrolled

Metabolism-informed Care for Smoking Cessation

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

Clinical Trial to Evaluate the Efficacy of Smoking Cessation

Completed·JJosep Maria Ramon Torrell, PhD·Phase 4·NCT01538394·322 enrolled

Study of Varenicline (Champix) for Smoking Cessation/Reduction in Patients With Bipolar Disorder

Completed·CCentre for Addiction and Mental Health·N/A·NCT01093937·30 enrolled

Combining Varenicline and Guanfacine for Smoking Cessation

Completed·YYale University·Phase 2·NCT04198116·165 enrolled

Smoking Habits and Smoking Cessation in Young Adults

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

New Approaches to Smoking Cessation in Heavy Drinkers

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

Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers

Completed·NNorthwestern University·Phase 4·NCT02378714·300 enrolled

A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

Completed· Pfizer logo

Pfizer·Phase 4·NCT01244061·498 enrolled

A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

Withdrawn· Pfizer logo

Pfizer·Phase 2·NCT00741884

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

Completed· Pfizer logo

Pfizer·Phase 3·NCT00143364·1,005 enrolled

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

Completed· Pfizer logo

Pfizer·Phase 3·NCT00141206·1,005 enrolled

An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation

Completed· Pfizer logo

Pfizer·Phase 3·NCT00143325·730 enrolled

A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

Completed· Pfizer logo

Pfizer·Phase 3·NCT00143286·2,000 enrolled

Smoking Cessation Treatment for Head and Neck Cancer Patients

Terminated·YYale University·Phase 1·NCT00931021·7 enrolled

Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation

Recruiting·OOttawa Heart Institute Research Corporation·Phase 4·NCT06832085·150 enrolled

Tailored Smoking Cessation Treatment for LIVE FOR LIFE® Participants

Terminated·—·Phase 2/3·NCT01560507·19 enrolled

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

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

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

Completed· Pfizer logo

Pfizer·Phase 4·NCT01078298·525 enrolled

Varenicline for Adolescent Smoking Cessation

Completed·MMedical University of South Carolina·Phase 3·NCT01509547·157 enrolled

Smoking14 trials

Wellness Intervention for Smoking and HIV

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

Show 11 more trials

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

Effects of Varenicline on Smoking Reminders

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

Pharmacogenetics, Emotional Reactivity and Smoking

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

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

Treatment12 trials

Varenicline in Drug Treatment

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

Tobacco Treatment Comparison for Cancer Care

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

A Study of Varenicline in the Treatment of Visceral Sensation

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

Show 9 more trials

Varenicline Treatment for Active Alcoholic Smokers

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

Extended Varenicline Treatment for Smoking Among Cancer Patients

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

UW Quitting Using Intensive Treatment Study (QUITS)

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT03176784·1,251 enrolled

Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

Completed·JJoseph Valentino, MD·Phase 2·NCT04634071·126 enrolled

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

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

Cannabis-Tobacco Co-Use Treatment Study

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

Treatment of Smoking Among Individuals With PTSD

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

Pharmacogenetics of Nicotine Addiction Treatment

Completed·UUniversity of Pennsylvania·Phase 3·NCT01314001·1,246 enrolled

STARS (Smoking Treatment And Remote Sampling) Study

Completed·MMedical University of South Carolina·Phase 1/2·NCT04525755·652 enrolled

Smokers8 trials

Varenicline Effects In Schizophrenic Smokers

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

Varenicline for Light Smokers

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

Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

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

Show 5 more trials

Human Laboratory Study Of Varenicline in Smokers

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

Varenicline + Prazosin for Heavy Drinking Smokers

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

Effects of Varenicline in Heavy Drinking Smokers

Withdrawn·UUniversity of California, Los Angeles·Phase 4·NCT02488889

Financial Incentives for Homeless Smokers: A Community-based RCT

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

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

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

Schizophrenia8 trials

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

Effects of Varenicline on Plasticity in Schizophrenia

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

Show 5 more trials

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

Effect of Varenicline on Cognitive Function in Cigarette Smokers With Schizophrenia

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

The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia

Completed·IInje University·Phase 3·NCT00523445·120 enrolled

70 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 Treatment of Alcohol Dependence in Smokers

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

Show 3 more trials

Varenicline for Alcohol Dependence

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

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

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

Varenicline for Alcohol Dependence

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

Efficacy and Safety3 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

Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)

Completed·MMaastricht University Medical Center·Phase 2·NCT00995033·558 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

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

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

Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction

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

Methamphetamine Dependence3 trials

Varenicline as a Treatment for Methamphetamine Dependence

Completed·—·Phase 1·NCT01571167·17 enrolled

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

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

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

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

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

Effectiveness2 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

Smokeless Tobacco2 trials

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

Tobacco Dependence2 trials

Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

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

Using Non-invasive Brain Stimulation (tDCS) With Varenicline for Treating Tobacco Dependence

Completed·CCentre for Addiction and Mental Health·N/A·NCT03841292·41 enrolled

Nicotine Dependence2 trials

Varenicline for Nicotine Dependence Among Those With HIV/AIDS

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

Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

Completed·UUniversity of Minnesota·Phase 2/3·NCT00749658·121 enrolled

Tobacco Cessation2 trials

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

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

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

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

Alcohol Use Disorder2 trials

Human Laboratory Study of Varenicline for Alcohol Use Disorder

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

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

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

Alcohol Consumption2 trials

Varenicline to Reduce Alcohol Consumption in Heavy Drinkers

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

Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

Completed·SSahlgrenska University Hospital·Phase 2·NCT00846859·162 enrolled

Addiction2 trials

Varenicline and Alcohol in Inpatient Addictions Program (IAP)

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

Translational Neuropsychopharmacology Research of Nicotine Addiction

Completed·MMedical University of South Carolina·Phase 2·NCT02723162·67 enrolled

Eye Disease2 trials

A Randomized, Controlled, Double-masked, Investigator-initiated Trial to Evaluate Tear Film Quality and Stability in Subjects With Dry Eye Disease Using OC-01 (Varenicline Solution) Nasal Spray 0.03 mg as Compared to Vehicle Control Nasal Spray

Unknown status·SStephenson Eye Associates·Phase 4·NCT05514041·60 enrolled

Nasal Spray Study in Sjogren's Dry Eye Disease

Completed·UUniversity of Pennsylvania·Phase 4·NCT05700422·39 enrolled

Depressed1 trial

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

Completed·—·N/A·NCT00525837·18 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

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

Cognition1 trial

Varenicline on Reward Responses and Cognition in Adolescent Smokers

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

Asthma1 trial

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

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

Cigarette Smoker1 trial

Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers

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

Weight Gain1 trial

Lorcaserin for Preventing Weight Gain Among Smokers

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

Substance Use Disorders1 trial

Varenicline and Motivational Advice for Smokers With Substance Use Disorders

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

Cognitive impairment1 trial

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

Withdrawn· Pfizer logo

Pfizer·Phase 2·NCT00743847

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

Methadone1 trial

Efficacy of Varenicline in Methadone-Stabilized Cocaine Users

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

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

Labor1 trial

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

Withdrawn·JJennifer Plebani·Phase 2·NCT01143857

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

Mental Illness1 trial

Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

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

Medication Adherence1 trial

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

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

Safety and Efficacy1 trial

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

Completed· Pfizer logo

Pfizer··NCT00483002·3,719 enrolled

AIN1 trial

Effects of Varenicline on Brain Activity During Nicotine Abstinence

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

Opioid Dependence1 trial

Pilot Study of Varenicline to Treat Opioid Dependence

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

E-cigarette Use1 trial

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

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

Vaping Cessation1 trial

Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents

Terminated·MMassachusetts General Hospital·Phase 4·NCT04602494·5 enrolled

Relapse1 trial

Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

Recruiting·YYale University·Phase 2·NCT06609369·114 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

Cocaine Dependence1 trial

Chantix for Treating Cocaine Dependence

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

Parkinson's Disease1 trial

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

Hypertensive1 trial

Smoking Study With Behavioral Therapy for Hypertensive Patients

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

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

Efficacy1 trial

Efficacy of Varenicline in Ambivalent Smokers

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

Tobacco Use Disorder1 trial

Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans

Withdrawn·VVA Office of Research and Development·Phase 2·NCT05294263

Cannabis1 trial

Cannabis and Tobacco Co-use Study

Completed·MMedical University of South Carolina·Phase 4·NCT04228965·181 enrolled

Psychiatric Disorder1 trial

Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders

Withdrawn·HHospital Universitari Vall d'Hebron Research Institute·Phase 4·NCT03809897

Schizoaffective Disorder1 trial

Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder

Completed· Pfizer logo

Pfizer·Phase 3·NCT00644969·128 enrolled

Attention Deficit Hyperactivity Disorder1 trial

Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)

Terminated·MMassachusetts General Hospital·Phase 4·NCT00907218·2 enrolled

Cancer1 trial

Hollings Cancer Center Varenicline Sampling Study

Completed·MMedical University of South Carolina·Phase 1·NCT03742154·99 enrolled

Interaction1 trial

Varenicline and Nicotine Interactions in Humans (VA)

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

Craving1 trial

Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

Withdrawn·—·N/A·NCT00525928

Spinocerebellar ataxia type 31 trial

Study to Determine the Safety and Tolerability of Varenicline (Chantix®) in Treating Spinocerebellar Ataxia Type 3

Completed·UUniversity of South Florida·Phase 2·NCT00992771·20 enrolled

Unspecified7 trials

Varenicline In-Patient Study

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

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

Completed· Pfizer logo

Pfizer··NCT01061710·20 enrolled

Tailoring Varenicline to Individual Needs (TVIN Study)

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

Show 4 more trials

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

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

A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline

Completed· Pfizer logo

Pfizer·Phase 3·NCT00143299·375 enrolled

Smoke-Free Living Study

Completed·UUniversity of British Columbia·Phase 1·NCT00832806·100 enrolled

Effects of Varenicline on Cigarette Self Administration

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

Regulatory

FDA Approval Timeline[5]

May 10, 2006

CHANTIX

NDA NDA021928

May 10, 2006

CHANTIX

NDA NDA021928

Nov 20, 2007

CHANTIX

NDA NDA021928

Jan 31, 2008

CHANTIX

NDA NDA021928

May 16, 2008

CHANTIX

NDA NDA021928

Jul 1, 2009

CHANTIX

NDA NDA021928

Jul 1, 2009

CHANTIX

NDA NDA021928

Oct 19, 2009

CHANTIX

NDA NDA021928

Feb 4, 2010

CHANTIX

NDA NDA021928

Apr 22, 2010

CHANTIX

NDA NDA021928

Apr 22, 2010

CHANTIX

NDA NDA021928

Dec 17, 2010

CHANTIX

NDA NDA021928

Feb 17, 2011

CHANTIX

NDA NDA021928

Jun 29, 2011

CHANTIX

NDA NDA021928

Jul 22, 2011

CHANTIX

NDA NDA021928

Jul 22, 2011

CHANTIX

NDA NDA021928

Jul 22, 2011

CHANTIX

NDA NDA021928

Nov 9, 2011

CHANTIX

NDA NDA021928

Jan 20, 2012

CHANTIX

NDA NDA021928

Dec 11, 2012

CHANTIX

NDA NDA021928

Feb 19, 2013

CHANTIX

NDA NDA021928

Jul 28, 2014

CHANTIX

NDA NDA021928

Sep 19, 2014

CHANTIX

NDA NDA021928

Sep 19, 2014

CHANTIX

NDA NDA021928

Sep 19, 2014

CHANTIX

NDA NDA021928

Oct 15, 2014

CHANTIX

NDA NDA021928

Oct 15, 2014

CHANTIX

NDA NDA021928

Oct 15, 2014

CHANTIX

NDA NDA021928

Aug 12, 2016

CHANTIX

NDA NDA021928

Aug 12, 2016

CHANTIX

NDA NDA021928

Dec 16, 2016

CHANTIX

NDA NDA021928

Oct 16, 2017

CHANTIX

NDA NDA021928

Jun 1, 2018

CHANTIX

NDA NDA021928

Jun 1, 2018

CHANTIX

NDA NDA021928

Feb 22, 2019

CHANTIX

NDA NDA021928

Oct 15, 2021

TYRVAYA

NDA NDA213978

Jun 24, 2025

CHANTIX

NDA NDA021928

Sources

References

[1]
ClinicalTrials.gov — 246 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 NDA021928). 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 18, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12653824Oct 18, 2035

10456396Oct 19, 2035

9597284Oct 19, 2035

9532944Oct 19, 2035

9504644Oct 19, 2035

7 more patents

11911380Oct 19, 2035

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11903943Oct 19, 2035