{"id":"long-term-varenicline","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT00285012","NCT00937508","NCT00143325","NCT00691483","NCT00818207","NCT00977249","NCT00828113","NCT00143286","NCT00282984","NCT01243203","NCT01370356","NCT03722966","NCT01320462","NCT00717093","NCT00141167","NCT01934023","NCT00139750","NCT00992771","NCT01162239","NCT00143364","NCT00141206","NCT03365362","NCT03262662"],"aliases":[],"patents":[],"pricing":[],"allNames":"long-term varenicline","offLabel":[],"timeline":[{"date":"2007","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase 3 trial (Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking) — Smoking Cessation"},{"date":"2009","type":"neutral","milestone":"Phase 4 Initiated","description":"Phase 4 trial (Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use) — Tobacco Use Cessation"},{"date":"2011","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Study to Determine the Safety and Tolerability of Varenicline (Chantix®) in Treating Spinocerebellar) — Spinocerebellar Ataxia Type 3"}],"aiSummary":"Long-Term Varenicline is a partial agonist of the α4β2 nicotinic acetylcholine receptor approved for smoking cessation. It reduces cravings and withdrawal symptoms while blocking the rewarding effects of nicotine by binding to receptors in the brain that nicotine normally activates. Its extended duration of action supports sustained abstinence beyond standard treatment periods.","brandName":"Long-Term Varenicline","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Varenicline tablet x 24 weeks","explanation":"When someone smokes, nicotine floods into the brain and activates specific receptor proteins called α4β2 nicotinic acetylcholine receptors. This activation releases dopamine, the brain's 'reward' chemical, which reinforces the smoking habit and creates cravings when nicotine levels drop. Varenicline works by sitting on these same receptors and partially activating them—enough to ease withdrawal symptoms and reduce cravings, but not as powerfully as nicotine itself.\n\nBy occupying these receptors, varenicline also blocks nicotine from attaching and activating them fully. This means if someone does smoke while taking the medication, they don't get the strong dopamine rush that normally rewards and reinforces smoking behavior. This dual action—reducing cravings while eliminating the satisfaction from smoking—makes quitting more tolerable and successful.\n\nThe long-term formulation extends treatment duration beyond the standard 12-week course, providing continued brain-receptor occupancy to sustain cessation benefits and reduce relapse risk. This prolonged support acknowledges that nicotine addiction involves deep brain changes that take time to normalize, and maintaining medication coverage during the critical period when relapse risk remains elevated improves long-term abstinence rates.","oneSentence":"Varenicline tablet x 24 weeks","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"long-term-varenicline","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Tobacco Use Disorder","phase":"preclinical","trialId":"","patients":null,"diseaseId":"unknown","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00285012","phase":"Phase 3","title":"Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":504,"indication":"Smoking Cessation","completionDate":"2008-07","primaryEndpoint":"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."},{"nctId":"NCT00937508","phase":"Phase 4","title":"Smoking Cessation Program in the Preadmission Clinic","status":"Unknown","sponsor":"University Health Network, Toronto","isPivotal":false,"enrollment":290,"indication":"Smoking","completionDate":"2010-07","primaryEndpoint":"This study is a randomized, double-blind, placebo-controlled clinical trial which evaluates the efficacy of preoperative smoking counseling and varenicline (a medication approved by Health Canada and "},{"nctId":"NCT00143325","phase":"Phase 3","title":"An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":730,"indication":"Smoking Cessation","completionDate":"","primaryEndpoint":"Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation."},{"nctId":"NCT00691483","phase":"Phase 4","title":"Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Ces","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":659,"indication":"Smoking Cessation","completionDate":"2009-09","primaryEndpoint":"The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment."},{"nctId":"NCT00818207","phase":"Phase 4","title":"Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1380,"indication":"Smoking Cessation","completionDate":"2010-03","primaryEndpoint":"This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated t"},{"nctId":"NCT00977249","phase":"Phase 2/3","title":"Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users","status":"Unknown","sponsor":"University Hospital, Gentofte, Copenhagen","isPivotal":false,"enrollment":200,"indication":"Tobacco Dependence","completionDate":"2011-12","primaryEndpoint":"Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?"},{"nctId":"NCT00828113","phase":"Phase 4","title":"Long-term Varenicline Treatment for Smoking Cessation","status":"Completed","sponsor":"University of Wisconsin, Madison","isPivotal":false,"enrollment":101,"indication":"Smoking","completionDate":"2010-09","primaryEndpoint":"This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation."},{"nctId":"NCT00143286","phase":"Phase 3","title":"A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of","status":"Completed","sponsor":"Pfizer","isPivotal":true,"enrollment":2000,"indication":"Smoking Cessation","completionDate":"","primaryEndpoint":"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-we"},{"nctId":"NCT00282984","phase":"Phase 3","title":"Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":714,"indication":"Smoking Cessation","completionDate":"2007-11","primaryEndpoint":"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."},{"nctId":"NCT01243203","phase":"N/A","title":"Smoking Cessation Program in the Preadmission Clinic: The Use of a Teachable Moment","status":"Completed","sponsor":"University Health Network, Toronto","isPivotal":false,"enrollment":300,"indication":"Smoking","completionDate":"2010-11","primaryEndpoint":"The Objective of this study is to introduce a practically feasible multifaceted intervention in the preadmission clinic to help reduce smoking in preoperative surgical patients."},{"nctId":"NCT01370356","phase":"Phase 4","title":"A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1510,"indication":"Smoking Cessation","completionDate":"2013-07","primaryEndpoint":"This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt."},{"nctId":"NCT03722966","phase":"Phase 2","title":"Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)","status":"Terminated","sponsor":"University of Oklahoma","isPivotal":false,"enrollment":34,"indication":"Smoking Cessation","completionDate":"2022-02","primaryEndpoint":"Varenicline is considered to be a first-line tobacco cessation treatment."},{"nctId":"NCT01320462","phase":"N/A","title":"Smoking Cessation Program in the Preadmission Clinic","status":"Completed","sponsor":"University Health Network, Toronto","isPivotal":false,"enrollment":296,"indication":"Smoking","completionDate":"2017-04","primaryEndpoint":"Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by quit line) in the preoperative clinic is more effective than the simple preoper"},{"nctId":"NCT00717093","phase":"Phase 4","title":"Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":432,"indication":"Tobacco Use Cessation","completionDate":"2009-04","primaryEndpoint":"The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco."},{"nctId":"NCT00141167","phase":"Phase 3","title":"A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Ce","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":250,"indication":"Smoking Cessation","completionDate":"","primaryEndpoint":"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."},{"nctId":"NCT01934023","phase":"Phase 2","title":"Effects of Varenicline on Plasticity in Schizophrenia","status":"Completed","sponsor":"Centre for Addiction and Mental Health","isPivotal":false,"enrollment":24,"indication":"Schizophrenia","completionDate":"2015-08","primaryEndpoint":"This laboratory pilot study will explore the effects of varenicline tartrate on long-term potentiation (LTP)-like mechanisms of (1) the motor cortex and (2) the dorsolateral prefrontal cortex (DLPFC) "},{"nctId":"NCT00139750","phase":"Phase 2","title":"12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessa","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":600,"indication":"Smoking Cessation","completionDate":"","primaryEndpoint":"The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-trea"},{"nctId":"NCT00992771","phase":"Phase 2","title":"Study to Determine the Safety and Tolerability of Varenicline (Chantix®) in Treating Spinocerebellar","status":"Completed","sponsor":"University of South Florida","isPivotal":false,"enrollment":20,"indication":"Spinocerebellar Ataxia Type 3","completionDate":"2011-04","primaryEndpoint":"Spinocerebellar ataxia (SCA) is a group of inherited disorders characterized by cerebellar degeneration leading to imbalance, incoordination, speech difficulties and problems with walking."},{"nctId":"NCT01162239","phase":"Phase 3","title":"Maintaining Nonsmoking","status":"Completed","sponsor":"University of California, San Francisco","isPivotal":false,"enrollment":216,"indication":"Nicotine Dependence","completionDate":"2016-06","primaryEndpoint":"The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful."},{"nctId":"NCT00143364","phase":"Phase 3","title":"A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1005,"indication":"Smoking Cessation","completionDate":"","primaryEndpoint":"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."},{"nctId":"NCT00141206","phase":"Phase 3","title":"A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1005,"indication":"Smoking Cessation","completionDate":"","primaryEndpoint":"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."},{"nctId":"NCT03365362","phase":"Phase 4","title":"A Trial of Directly Observed and Long-term Varenicline","status":"Completed","sponsor":"Albert Einstein College of Medicine","isPivotal":false,"enrollment":243,"indication":"Tobacco Use Disorder","completionDate":"2023-11","primaryEndpoint":"This 2 x 2 factorial, randomized, double-blind, placebo-controlled trial will test two interventions: directly observed medication therapy, and long-term therapy with varenicline among smokers with op"},{"nctId":"NCT03262662","phase":"Phase 3","title":"EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking","status":"Completed","sponsor":"State University of New York at Buffalo","isPivotal":false,"enrollment":320,"indication":"Tobacco Smoking","completionDate":"2021-04","primaryEndpoint":"Varenicline is the most effective smoking cessation therapy available."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL1076903"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Other"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":3,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}