{"id":"vi-0521-top-dose","safety":{"commonSideEffects":[{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Dry mouth"},{"rate":null,"effect":"Increased heart rate"},{"rate":null,"effect":"Elevated blood pressure"},{"rate":null,"effect":"Nervousness or anxiety"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL6060199","moleculeType":null,"molecularWeight":"383.88"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"VI-0521 Top Dose contains phentermine, which stimulates the release of norepinephrine in the central nervous system, leading to appetite suppression and increased metabolic rate. This mechanism helps reduce caloric intake and promote weight loss when combined with diet and exercise modifications.","oneSentence":"VI-0521 is a phentermine-based combination product that acts as a sympathomimetic amine to suppress appetite and increase energy expenditure for weight management.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:15:15.300Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Obesity management in patients with BMI ≥30 kg/m² or BMI ≥27 kg/m² with weight-related comorbidities"}]},"trialDetails":[{"nctId":"NCT05215418","phase":"PHASE4","title":"A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects","status":"COMPLETED","sponsor":"VIVUS LLC","startDate":"2022-01-25","conditions":"Blood Pressure","enrollment":565},{"nctId":"NCT03922945","phase":"PHASE4","title":"A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity","status":"COMPLETED","sponsor":"VIVUS LLC","startDate":"2019-05-02","conditions":"Adolescent Obesity, Obesity in Adolescence, Adolescent Overweight","enrollment":223},{"nctId":"NCT02714062","phase":"PHASE4","title":"A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents","status":"COMPLETED","sponsor":"VIVUS LLC","startDate":"2016-03","conditions":"Pediatric Obesity, Childhood Obesity","enrollment":42},{"nctId":"NCT00563368","phase":"PHASE3","title":"A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults","status":"COMPLETED","sponsor":"VIVUS LLC","startDate":"2007-12","conditions":"Obesity","enrollment":756},{"nctId":"NCT00554216","phase":"PHASE3","title":"Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults","status":"COMPLETED","sponsor":"VIVUS LLC","startDate":"2007-11","conditions":"Obesity","enrollment":1267},{"nctId":"NCT00553787","phase":"PHASE3","title":"Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions","status":"COMPLETED","sponsor":"VIVUS LLC","startDate":"2007-11","conditions":"Obesity, Type 2 Diabetes","enrollment":2487}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Phentermine/Topiramate"],"phase":"marketed","status":"active","brandName":"VI-0521 Top Dose","genericName":"VI-0521 Top Dose","companyName":"VIVUS LLC","companyId":"vivus-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"VI-0521 is being studied in clinical trials for its effects on ambulatory blood pressure in overweight or obese subjects, as well as for its potential benefits in treating conditions such as type 2 diabetes and obesity. The study compares VI-0521 to phentermine and a placebo in a randomized, double-blind trial.","enrichmentLevel":3,"visitCount":8,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}