{"id":"antara-fenofibrate","safety":{"commonSideEffects":[{"rate":null,"effect":"Elevated liver enzymes (ALT/AST)"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Rash"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fenofibrate is a fibric acid derivative that acts as a PPARα agonist, enhancing the transcription of genes involved in lipid metabolism. This leads to increased lipolysis and elimination of triglyceride-rich particles from the bloodstream, while simultaneously raising HDL cholesterol levels. It is primarily used to treat dyslipidemia, particularly hypertriglyceridemia and mixed lipid disorders.","oneSentence":"Fenofibrate activates peroxisome proliferator-activated receptor alpha (PPARα) to reduce triglycerides and increase HDL cholesterol.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:29:52.638Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertriglyceridemia"},{"name":"Mixed dyslipidemia"},{"name":"Primary hypercholesterolemia"}]},"trialDetails":[{"nctId":"NCT07025005","phase":"PHASE4","title":"Fenofibrate Role in the Prophylaxis From Peripheral Neuropathy Induced by Bortezomib, Lenalidomide and Dexamethasone (VRd) Protocol in the Treatment of Patients With Multiple Myeloma (MM)","status":"RECRUITING","sponsor":"Tanta University","startDate":"2025-08-30","conditions":"Peripheral Neuropathy, Multiple Myeloma, Neoplasms","enrollment":44},{"nctId":"NCT03615534","phase":"PHASE4","title":"Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females","status":"COMPLETED","sponsor":"Lewai Sharki Abdulaziz, MSc PhD","startDate":"2014-10-01","conditions":"Atherogenic Dyslipidemia, Obesity Associated Disorder","enrollment":161},{"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":"NCT04661930","phase":"PHASE3","title":"Fenofibrate for Patients With COVID-19 Requiring Hospitalization","status":"UNKNOWN","sponsor":"Yaakov Nahmias","startDate":"2021-01-01","conditions":"Corona Virus Disease (COVID-19), Respiratory Distress Syndrome, SARS-CoV-2 Infection","enrollment":55},{"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":"NCT02781584","phase":"PHASE2","title":"Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-06-13","conditions":"Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD)","enrollment":220},{"nctId":"NCT04882293","phase":"PHASE3","title":"Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.","status":"UNKNOWN","sponsor":"Laboratorios Silanes S.A. de C.V.","startDate":"2022-02-15","conditions":"Dyslipidemia Associated With Type II Diabetes Mellitus","enrollment":78},{"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":"NCT00613613","phase":"","title":"Fenofibrate and Pharmacogenetic Impact in Dyslipidemia","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2008-01","conditions":"Dyslipidemia","enrollment":56},{"nctId":"NCT02984982","phase":"PHASE4","title":"Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia","status":"COMPLETED","sponsor":"Sanofi","startDate":"2016-11-15","conditions":"Hypercholesterolemia, Acute Coronary Syndrome","enrollment":206},{"nctId":"NCT02354976","phase":"PHASE2","title":"A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2015-09-01","conditions":"Non-alcoholic Fatty Liver Disease (NAFLD, Hypertriglyceridemia","enrollment":78},{"nctId":"NCT02023879","phase":"PHASE3","title":"Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2013-12-16","conditions":"Hypercholesterolemia","enrollment":233},{"nctId":"NCT02079376","phase":"NA","title":"The DIAMOND® for the Treatment of Type 2 Diabetes","status":"UNKNOWN","sponsor":"MetaCure Limited","startDate":"2013-11","conditions":"Type 2 Diabetes","enrollment":45},{"nctId":"NCT00928694","phase":"PHASE1","title":"Fenofibrate Bioequivalence Study (0767-031)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2003-02","conditions":"Dyslipidemia","enrollment":14},{"nctId":"NCT02314533","phase":"PHASE4","title":"Evaluate the Efficacy of Fenofibrate on Microalbuminuria","status":"UNKNOWN","sponsor":"Beijing Chao Yang Hospital","startDate":"2014-12","conditions":"Microalbuminuria","enrollment":200},{"nctId":"NCT02306902","phase":"NA","title":"Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fed Conditions","status":"COMPLETED","sponsor":"Ranbaxy Laboratories Limited","startDate":"2009-10","conditions":"Healthy","enrollment":24},{"nctId":"NCT02306889","phase":"NA","title":"Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fasting Conditions","status":"COMPLETED","sponsor":"Ranbaxy Laboratories Limited","startDate":"2010-01","conditions":"Healthy","enrollment":48},{"nctId":"NCT01353404","phase":"PHASE1","title":"Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)","status":"COMPLETED","sponsor":"Samyang Biopharmaceuticals Corporation","startDate":"2011-06","conditions":"Hyperlipidemia","enrollment":24},{"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":"NCT00961116","phase":"PHASE1","title":"Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)","status":"COMPLETED","sponsor":"Mutual Pharmaceutical Company, Inc.","startDate":"2007-10","conditions":"Healthy","enrollment":54},{"nctId":"NCT00960687","phase":"PHASE1","title":"Fed Bioequivalence Study of Fenofibric Acid Versus TriCor® (Fenofibrate)","status":"COMPLETED","sponsor":"Mutual Pharmaceutical Company, Inc.","startDate":"2007-10","conditions":"Healthy","enrollment":54},{"nctId":"NCT00775359","phase":"NA","title":"Bioequivalence Study of Fenofibrate 160mg Tablets Under Fed Conditions","status":"COMPLETED","sponsor":"Ranbaxy Laboratories Limited","startDate":"2002-08","conditions":"Healthy","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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)","genericName":"ANTARA® (fenofibrate)","companyName":"Ranbaxy Laboratories Limited","companyId":"ranbaxy-laboratories-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fenofibrate activates peroxisome proliferator-activated receptor alpha (PPARα) to reduce triglycerides and increase HDL cholesterol. Used for Hypertriglyceridemia, Mixed dyslipidemia, Primary hypercholesterolemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}