{"id":"0-5mg-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":"0.5mg 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":"0.5mg Varenicline taken twice a day is used to treat tobacco dependence, withdrawal symptoms, and smoking cessation. Varenicline's mechanism of action involves binding to nicotinic acetylcholine receptors, which is consistent with its use in smoking cessation.","brandName":"0.5mg 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 attaching to nicotine receptors in your brain—the same receptors that nicotine normally stimulates. However, varenicline only partially activates these receptors, providing just enough stimulation to significantly reduce the intense cravings and withdrawal discomfort that smokers experience when quitting. This partial activation keeps your brain's reward system somewhat satisfied without the full \"high\" that smoking provides.\n\nThe second part of varenicline's strategy is equally important: because it occupies these same nicotine receptors, it physically blocks actual nicotine from attaching to them. If you slip and smoke a cigarette while taking varenicline, the nicotine cannot reach its target receptors as effectively, which means smoking no longer produces the satisfying and reinforcing sensation you're accustomed to. This removes much of the motivation to keep smoking.\n\nThe 0.5mg twice-daily dosing provides continuous brain coverage throughout the day, maintaining steady levels of the medication so you get consistent relief from cravings. This regular dosing schedule, combined with varenicline's two-pronged approach, makes it one of the most effective pharmaceutical aids for smoking cessation.","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":"0-5mg-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":""},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Other"],"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}}