{"id":"1-0mg-varenicline-b-i-d","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT03557294"],"aliases":[],"patents":[],"pricing":[],"allNames":"1.0mg varenicline b.i.d.","offLabel":[],"timeline":[{"date":"2022","type":"neutral","milestone":"Phase 4 Initiated","description":"Phase 4 trial (Varenicline OTC Trial on Efficacy and Safety) — Tobacco Dependence"}],"aiSummary":"Varenicline 1.0mg twice daily is a nicotinic receptor partial agonist approved for smoking cessation. It reduces nicotine cravings and withdrawal symptoms while blocking the rewarding effects of cigarettes, making it one of the most effective pharmacologic aids for quitting smoking.","brandName":"1.0mg Varenicline b.i.d.","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both t","explanation":"Varenicline works by binding to specific receptors in your brain called nicotinic acetylcholine receptors—the same receptors that nicotine normally activates. As a partial agonist, varenicline acts like a weak version of nicotine, providing just enough stimulation to reduce the intense cravings and withdrawal discomfort that make quitting smoking so difficult. This approach is gentler than nicotine replacement therapy because it delivers a controlled, steady signal rather than mimicking the dramatic spikes from smoking.\n\nSimultaneously, varenicline blocks nicotine from attaching to these same receptors. If you do smoke while taking the medication, nicotine can't activate the reward pathways in your brain as strongly, making cigarettes far less satisfying. This dual action—reducing cravings while eliminating the pleasure from smoking—addresses both the physical addiction and the reinforcing cycle that keeps people smoking.\n\nAt the standard dose of 1.0mg twice daily, varenicline reaches levels in your bloodstream that effectively occupy these brain receptors for most of the day. Over the typical 12-week treatment course, this allows your brain chemistry to gradually normalize while you break the behavioral habits of smoking, significantly improving your chances of successfully quitting.","oneSentence":"Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both t","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"1-0mg-varenicline-b-i-d","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Tobacco Dependence","phase":"preclinical","trialId":"","patients":null,"diseaseId":"unknown","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03557294","phase":"Phase 4","title":"Varenicline OTC Trial on Efficacy and Safety","status":"Completed","sponsor":"Arizona State University","isPivotal":false,"enrollment":313,"indication":"Tobacco Dependence","completionDate":"2022-04","primaryEndpoint":"The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL1076903"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Hematology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":3,"trialStats":{"total":1,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}