{"id":"vesomni","safety":{"commonSideEffects":[{"rate":null,"effect":"Retrograde ejaculation"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Nasopharyngitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Silodosin relaxes smooth muscle in the prostate and bladder neck by blocking alpha-1A adrenergic receptors, reducing urinary obstruction. Mirabegron relaxes the detrusor muscle via beta-3 adrenergic agonism, increasing bladder capacity and reducing overactive bladder symptoms. The combination targets complementary pathways to improve both lower urinary tract obstruction and urgency/frequency symptoms.","oneSentence":"Vesomni is a combination of silodosin (alpha-1A adrenergic antagonist) and mirabegron (beta-3 adrenergic agonist) that addresses both obstructive and storage symptoms of benign prostatic hyperplasia.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:40:33.241Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Benign prostatic hyperplasia with lower urinary tract symptoms (obstructive and storage symptoms)"}]},"trialDetails":[{"nctId":"NCT01018511","phase":"PHASE3","title":"Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2010-01-11","conditions":"Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms","enrollment":1334},{"nctId":"NCT06546735","phase":"PHASE3","title":"Efficacy and Safety of Two Fixed-dose Combinations in Men with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. (BENIPRO)","status":"NOT_YET_RECRUITING","sponsor":"Eurofarma Laboratorios S.A.","startDate":"2026-11-30","conditions":"Benign Prostatic Hyperplasia with Lower Urinary Tract Symptoms","enrollment":816},{"nctId":"NCT02634489","phase":"PHASE1","title":"EC905 Pharmacokinetic Profile Study","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2009-03","conditions":"Phase 1, Healthy, Benign Prostatic Hyperplasia","enrollment":46},{"nctId":"NCT01953861","phase":"PHASE1","title":"A Study to Evaluate Whether Food Has an Effect on the Uptake of Solifenacin and Tamsulosin When Administered in a Combination Tablet","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2010-04","conditions":"EC905, Pharmacokinetics, Healthy Subjects","enrollment":52}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Vesomni®","genericName":"Vesomni®","companyName":"Eurofarma Laboratorios S.A.","companyId":"eurofarma-laboratorios-s-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Vesomni is a combination of silodosin (alpha-1A adrenergic antagonist) and mirabegron (beta-3 adrenergic agonist) that addresses both obstructive and storage symptoms of benign prostatic hyperplasia. Used for Benign prostatic hyperplasia with lower urinary tract symptoms (obstructive and storage symptoms).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}