{"id":"combodart","safety":{"commonSideEffects":[{"rate":"5-10","effect":"Erectile dysfunction"},{"rate":"3-8","effect":"Decreased libido"},{"rate":"5-15","effect":"Retrograde ejaculation"},{"rate":"2-5","effect":"Dizziness"},{"rate":"2-4","effect":"Headache"},{"rate":"1-3","effect":"Asthenia/fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Dutasteride inhibits both type I and type II 5-alpha reductase enzymes, reducing conversion of testosterone to dihydrotestosterone and shrinking the prostate gland. Tamsulosin relaxes smooth muscle in the prostate and bladder neck via alpha-1A receptor antagonism, improving urine flow. Together, these agents address both the obstructive and dynamic components of benign prostatic hyperplasia symptoms.","oneSentence":"Combodart combines dutasteride (a 5-alpha reductase inhibitor) and tamsulosin (an alpha-1A adrenergic receptor antagonist) to reduce prostate size and improve urinary symptoms in benign prostatic hyperplasia.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:06:55.550Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Benign prostatic hyperplasia with lower urinary tract symptoms"}]},"trialDetails":[{"nctId":"NCT07270432","phase":"PHASE3","title":"Efficacy/ Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia","status":"NOT_YET_RECRUITING","sponsor":"Ache Laboratorios Farmaceuticos S.A.","startDate":"2026-01","conditions":"Prostatic Hyperplasia, Benign","enrollment":218},{"nctId":"NCT02869971","phase":"PHASE3","title":"Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2016-08","conditions":"Benign Prostatic Hyperplasia","enrollment":90}],"_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":"Combodart®","genericName":"Combodart®","companyName":"Ache Laboratorios Farmaceuticos S.A.","companyId":"ache-laboratorios-farmaceuticos-s-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Combodart combines dutasteride (a 5-alpha reductase inhibitor) and tamsulosin (an alpha-1A adrenergic receptor antagonist) to reduce prostate size and improve urinary symptoms in benign prostatic hyperplasia. Used for Benign prostatic hyperplasia with lower urinary tract symptoms.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}