{"id":"antara-fenofibrate-lovaza","safety":{"commonSideEffects":[{"rate":"3-5","effect":"Myalgia or muscle pain"},{"rate":"2-4","effect":"Elevated liver enzymes (ALT/AST)"},{"rate":"5-10","effect":"Gastrointestinal upset (nausea, dyspepsia)"},{"rate":"2-3","effect":"Headache"},{"rate":"1-2","effect":"Rash"},{"rate":"1-2","effect":"Elevated creatinine/renal effects"}]},"_chembl":{"chemblId":"CHEMBL1201745","moleculeType":"Small molecule","molecularWeight":"421.92"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fenofibrate is a fibrate that activates peroxisome proliferator-activated receptor alpha (PPARα), increasing lipolysis and reducing triglyceride synthesis in the liver. Lovaza (omega-3-acid ethyl esters) provides high-dose EPA and DHA, which reduce hepatic triglyceride production and increase triglyceride clearance. Together, they provide complementary mechanisms to lower elevated triglycerides and improve lipid profiles in patients with dyslipidemia.","oneSentence":"This combination uses fenofibrate to activate PPARα and reduce triglycerides, while omega-3 fatty acids from Lovaza further lower triglycerides and reduce cardiovascular risk.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:24:20.413Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertriglyceridemia (elevated triglycerides)"},{"name":"Dyslipidemia in patients requiring combination lipid-lowering therapy"}]},"trialDetails":[{"nctId":"NCT01047501","phase":"PHASE3","title":"Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)","status":"COMPLETED","sponsor":"Amarin Pharma Inc.","startDate":"2009-12","conditions":"Hypertriglyceridemia","enrollment":702},{"nctId":"NCT01047683","phase":"PHASE3","title":"Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL","status":"COMPLETED","sponsor":"Amarin Pharma Inc.","startDate":"2009-12","conditions":"Hypertriglyceridemia","enrollment":229},{"nctId":"NCT01492361","phase":"PHASE3","title":"A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin","status":"COMPLETED","sponsor":"Amarin Pharma Inc.","startDate":"2011-11","conditions":"Cardiovascular Diseases","enrollment":8179},{"nctId":"NCT01594983","phase":"PHASE2","title":"A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-06","conditions":"Non Familial Chylocmicronemia Syndrome (Non-FCS)","enrollment":58},{"nctId":"NCT01048502","phase":"NA","title":"Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2010-01","conditions":"Cardiovascular Disease","enrollment":100},{"nctId":"NCT00891293","phase":"PHASE4","title":"A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-03","conditions":"Hypertriglyceridemia","enrollment":93},{"nctId":"NCT00246636","phase":"PHASE4","title":"Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-10","conditions":"Hypertriglyceridemia","enrollment":167}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Antara (fenofibrate) + Lovaza","genericName":"Antara (fenofibrate) + Lovaza","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination uses fenofibrate to activate PPARα and reduce triglycerides, while omega-3 fatty acids from Lovaza further lower triglycerides and reduce cardiovascular risk. Used for Hypertriglyceridemia (elevated triglycerides), Dyslipidemia in patients requiring combination lipid-lowering therapy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}