{"id":"omnic-ocas","safety":{"commonSideEffects":[{"rate":null,"effect":"Retrograde ejaculation"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Asthenia/fatigue"},{"rate":null,"effect":"Orthostatic hypotension"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tamsulosin is an alpha-1A selective antagonist that reduces smooth muscle tone in the prostate and bladder outlet, improving urine flow and reducing lower urinary tract symptoms. The Ocas (oral controlled absorption system) formulation provides sustained release of the active ingredient, allowing for once-daily dosing with improved tolerability compared to immediate-release formulations.","oneSentence":"Omnic Ocas is a once-daily oral formulation of tamsulosin that selectively blocks alpha-1A adrenergic receptors in the prostate and bladder neck to relieve urinary obstruction.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:40.033Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Benign prostatic hyperplasia with lower urinary tract symptoms"}]},"trialDetails":[{"nctId":"NCT04185441","phase":"PHASE3","title":"Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia","status":"COMPLETED","sponsor":"EMS","startDate":"2021-03-14","conditions":"Erectile Dysfunction, Benign Prostatic Hyperplasia","enrollment":295},{"nctId":"NCT07156916","phase":"PHASE1","title":"A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets, in Healthy Adult Male Subjects, Under Fasting Conditions","status":"RECRUITING","sponsor":"Berlin-Chemie AG Menarini Group","startDate":"2025-09-08","conditions":"Healthy Volunteer Male Subjects","enrollment":46},{"nctId":"NCT07146711","phase":"PHASE1","title":"A Comparative Bioavalability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tabsulosine 0.4 mg Tablets in Healthy Adult Male Subjects, at Steady State","status":"ACTIVE_NOT_RECRUITING","sponsor":"Berlin-Chemie AG Menarini Group","startDate":"2025-03-03","conditions":"Healthy Adult Males Volunteers","enrollment":33},{"nctId":"NCT07091669","phase":"PHASE1","title":"A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin 0.4 mg Tablets, in Healthy Adult Male Subjects, Under Fed Conditions","status":"ACTIVE_NOT_RECRUITING","sponsor":"Berlin-Chemie AG Menarini Group","startDate":"2025-06-16","conditions":"Healthy Volunteers, Male","enrollment":46},{"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":"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":"NCT00507455","phase":"PHASE2","title":"Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2007-06","conditions":"Lower Urinary Tract Symptoms, Bladder Outlet Obstruction","enrollment":222},{"nctId":"NCT01953887","phase":"PHASE1","title":"A Study to Compare the Amount of Drug in the Blood After a Single Tablet EC905 Containing Solifenacin and Tamsulosin is Taken by Healthy Males Compared to Separate Tablets of Solifenacin and Tamsulosin","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2010-03","conditions":"EC905, Pharmacokinetics, Healthy Subjects","enrollment":30},{"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":4,"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":"Omnic Ocas","genericName":"Omnic Ocas","companyName":"EMS","companyId":"ems","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Omnic Ocas is a once-daily oral formulation of tamsulosin that selectively blocks alpha-1A adrenergic receptors in the prostate and bladder neck to relieve urinary obstruction. Used for Benign prostatic hyperplasia with lower urinary tract symptoms.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}