{"id":"omega-3-acid-ethyl-esters-90","safety":{"commonSideEffects":[{"rate":null,"effect":"Eructation (fish-flavored burping)"},{"rate":null,"effect":"Dyspepsia"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Bleeding (minor, increased bleeding tendency)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This drug is a highly purified ethyl ester formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), omega-3 polyunsaturated fatty acids. It works by inhibiting hepatic synthesis of triglycerides and VLDL, while also enhancing the clearance of triglyceride-rich particles. The mechanism reduces circulating triglyceride concentrations, which is beneficial in managing hypertriglyceridemia and reducing cardiovascular risk.","oneSentence":"Omega-3-acid ethyl esters reduce triglyceride levels by decreasing hepatic production of triglyceride-rich lipoproteins and increasing clearance of triglycerides from the bloodstream.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:58:20.594Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertriglyceridemia (severe, typically ≥500 mg/dL)"},{"name":"Cardiovascular risk reduction in patients with elevated triglycerides"}]},"trialDetails":[{"nctId":"NCT06840964","phase":"NA","title":"Effect of Omega 3 in Hypertensive Patients","status":"COMPLETED","sponsor":"Santa Maria de la Salud, Argentina","startDate":"2023-03-23","conditions":"Hypertension, Dyslipidemia","enrollment":100},{"nctId":"NCT01821833","phase":"NA","title":"Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel","status":"COMPLETED","sponsor":"New Mexico Cancer Research Alliance","startDate":"2016-05-24","conditions":"Breast Cancer, Ovarian Neoplasm, Pain","enrollment":60},{"nctId":"NCT02899741","phase":"PHASE2","title":"Efficacy of Omega-3 as Adjunctive Therapy for Medically Intractable Epilepsy: A Prospective Open-label Pilot Study","status":"UNKNOWN","sponsor":"Seoul National University Hospital","startDate":"2016-08","conditions":"Epilepsy","enrollment":30},{"nctId":"NCT01350973","phase":"PHASE3","title":"Efficacy of TAK-085 in Participants With Hypertriglyceridemia","status":"COMPLETED","sponsor":"Takeda","startDate":"2009-11","conditions":"Hypertriglyceridemia","enrollment":611},{"nctId":"NCT01350999","phase":"PHASE3","title":"Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia","status":"COMPLETED","sponsor":"Takeda","startDate":"2009-11","conditions":"Hypertriglyceridemia","enrollment":503},{"nctId":"NCT02625870","phase":"PHASE3","title":"Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2015-12","conditions":"Hypertriglyceridemia","enrollment":240},{"nctId":"NCT01596842","phase":"PHASE4","title":"Effect of Omega-3 Fatty Acid on Vitamin D Activation","status":"COMPLETED","sponsor":"Dong-A University","startDate":"2012-05","conditions":"Hemodialysis Patients, Vitamin D Insufficiency, Vitamin D Deficiency","enrollment":17},{"nctId":"NCT02305355","phase":"PHASE4","title":"Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia","status":"COMPLETED","sponsor":"Kuhnil Pharmaceutical Co., Ltd.","startDate":"2009-02","conditions":"Diabetes Mellitus, Type 2, Hypertriglycemia","enrollment":68},{"nctId":"NCT01725646","phase":"PHASE3","title":"An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients","status":"COMPLETED","sponsor":"Excelsior","startDate":"2011-07","conditions":"Hypertriglyceridemia","enrollment":253},{"nctId":"NCT02035215","phase":"PHASE3","title":"Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb Hyperlipidemia","status":"UNKNOWN","sponsor":"Kuhnil Pharmaceutical Co., Ltd.","startDate":"2014-01","conditions":"Hyperlipidemia, Familial Combined","enrollment":80},{"nctId":"NCT00251134","phase":"PHASE3","title":"OMEGA-Study: Effect of Omega 3-Fatty Acids on the Reduction of Sudden Cardiac Death After Myocardial Infarction","status":"COMPLETED","sponsor":"Stiftung Institut fuer Herzinfarktforschung","startDate":"2003-10","conditions":"Myocardial Infarction","enrollment":3800},{"nctId":"NCT00257283","phase":"PHASE4","title":"Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis","status":"COMPLETED","sponsor":"Pronova BioPharma","startDate":"2002-11","conditions":"Kidney Failure, Chronic","enrollment":200},{"nctId":"NCT00296153","phase":"PHASE4","title":"Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment","status":"COMPLETED","sponsor":"Pronova BioPharma","startDate":"2006-02","conditions":"Human Immunodeficiency Virus, Ischemic Heart Disease","enrollment":51},{"nctId":"NCT00294216","phase":"PHASE3","title":"Omacor and Placebo in Carotid Plaque Stability","status":"COMPLETED","sponsor":"Pronova BioPharma","startDate":"2003-08","conditions":"Cardiovascular Disease","enrollment":121}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":9,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Omacor versus placebo"],"phase":"marketed","status":"active","brandName":"Omega-3-acid ethyl esters 90","genericName":"Omega-3-acid ethyl esters 90","companyName":"Pronova BioPharma","companyId":"pronova-biopharma","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Omega-3-acid ethyl esters reduce triglyceride levels by decreasing hepatic production of triglyceride-rich lipoproteins and increasing clearance of triglycerides from the bloodstream. Used for Hypertriglyceridemia (severe, typically ≥500 mg/dL), Cardiovascular risk reduction in patients with elevated triglycerides.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}