{"id":"amr101","safety":{"commonSideEffects":[{"rate":null,"effect":"Bleeding"},{"rate":null,"effect":"Atrial fibrillation"},{"rate":null,"effect":"Musculoskeletal pain"},{"rate":null,"effect":"Gout"}]},"_chembl":{"chemblId":"CHEMBL2095209","moleculeType":"Small molecule","molecularWeight":"330.51"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"AMR101 (icosapent ethyl) is a prescription-strength omega-3 fatty acid that selectively increases EPA levels in the blood. It works by reducing the production of triglycerides in the liver and promoting their clearance, thereby lowering circulating triglyceride levels in patients with elevated triglyceridemia, particularly those on statin therapy.","oneSentence":"AMR101 is a high-purity eicosapentaenoic acid (EPA) that reduces triglycerides by inhibiting hepatic triglyceride synthesis and enhancing fatty acid oxidation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:29.047Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertriglyceridemia in patients on statin therapy with elevated triglycerides"}]},"trialDetails":[{"nctId":"NCT06466278","phase":"PHASE2","title":"IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion","status":"ACTIVE_NOT_RECRUITING","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2023-06-01","conditions":"Aortic Valve Stenosis","enrollment":110},{"nctId":"NCT05198843","phase":"PHASE1, PHASE2","title":"Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2022-11-08","conditions":"Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Inflammatory Carcinoma","enrollment":1},{"nctId":"NCT04152291","phase":"NA","title":"The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism","status":"COMPLETED","sponsor":"Wihuri Research Institute","startDate":"2019-11-12","conditions":"Atherosclerosis, Low-density Lipoproteins Aggregation Susceptibility, Low-density Lipoprotein Lipid Composition","enrollment":68},{"nctId":"NCT03428477","phase":"PHASE3","title":"EPA for Metastasis Trial 2","status":"ACTIVE_NOT_RECRUITING","sponsor":"Mark A Hull, PhD FRCP","startDate":"2018-05-02","conditions":"Liver Metastasis, Colon Cancer","enrollment":418},{"nctId":"NCT06280976","phase":"PHASE4","title":"Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)","status":"WITHDRAWN","sponsor":"University of Louisville","startDate":"2024-03-01","conditions":"Coronary Artery Disease, Atherosclerosis, Heart Attack","enrollment":""},{"nctId":"NCT06758778","phase":"NA","title":"CreNeuroS™️CNS Fish Oil Plus Softgels Compared to Vascepa® Capsules and Deplin® Capsules in a Pharmacokinetic, Single Dose Evaluation on Healthy Adult Human Subjects Under Fasting Conditions","status":"ENROLLING_BY_INVITATION","sponsor":"Sichuan Credit Pharmaceutical Co., Ltd.","startDate":"2025-01-03","conditions":"Bioavailability","enrollment":14},{"nctId":"NCT06720662","phase":"NA","title":"Effect of Icosapent-ethyl Ester (IPE) to Reduce the Residual Risk Cardiovascular Disease.","status":"NOT_YET_RECRUITING","sponsor":"University of Sao Paulo","startDate":"2025-04-01","conditions":"Atherosclerosis Cardiovascular Disease","enrollment":294},{"nctId":"NCT06710080","phase":"PHASE3","title":"Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia","status":"NOT_YET_RECRUITING","sponsor":"Ottawa Heart Institute Research Corporation","startDate":"2024-12-15","conditions":"Inflammation, Community Acquired Pneumonia (CAP), Inflammation Plaque, Atherosclerotic","enrollment":168},{"nctId":"NCT04682665","phase":"","title":"Prebiotic Effect of Eicosapentaenoic Acid Treatment for Colorectal Cancer Liver Metastases","status":"COMPLETED","sponsor":"University of Leeds","startDate":"2021-09-16","conditions":"Colon Cancer Liver Metastasis","enrollment":81},{"nctId":"NCT02719327","phase":"PHASE2, PHASE3","title":"Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid","status":"COMPLETED","sponsor":"VA Office of Research and Development","startDate":"2017-06-08","conditions":"Alzheimer's Disease","enrollment":131},{"nctId":"NCT04239950","phase":"PHASE3","title":"Efficacy of Ethyl Icosapentate in Patients With Severe Hypertriglyceridemia","status":"COMPLETED","sponsor":"Mochida Pharmaceutical Company, Ltd.","startDate":"2020-05-09","conditions":"Hypertriglyceridemia","enrollment":316},{"nctId":"NCT04216251","phase":"PHASE1, PHASE2","title":"PRevention Using EPA Against coloREctal Cancer","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2020-12-09","conditions":"Colorectal Adenoma, Colorectal Cancer, Endoscopic Surgery","enrollment":81},{"nctId":"NCT04562467","phase":"PHASE4","title":"The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk","status":"COMPLETED","sponsor":"Canadian Medical and Surgical Knowledge Translation Research Group","startDate":"2020-09-24","conditions":"Cardiovascular Diseases, Cardiovascular Risk Factor, Triglycerides High","enrollment":70},{"nctId":"NCT04505098","phase":"PHASE4","title":"A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults","status":"TERMINATED","sponsor":"Kaiser Permanente","startDate":"2020-08-07","conditions":"Covid19, Atherosclerosis, Cardiovascular Diseases","enrollment":39600},{"nctId":"NCT05271591","phase":"","title":"Generalizability of REDUCE-IT Results to People of South Asian Descent With Atherosclerotic Cardiovascular Disease in Canada (REDUCE-IT Canada SA)","status":"COMPLETED","sponsor":"Canadian Medical and Surgical Knowledge Translation Research Group","startDate":"2022-03-05","conditions":"Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease, Myocardial Infarction","enrollment":200},{"nctId":"NCT02926027","phase":"PHASE4","title":"Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy","status":"COMPLETED","sponsor":"Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center","startDate":"2017-03-28","conditions":"Hypertriglyceridemia","enrollment":80},{"nctId":"NCT04811404","phase":"PHASE4","title":"A PET Study With [11C]PBR-28 and an Experimental Medication, Ethyl Eicosapentaenoic Acid","status":"WITHDRAWN","sponsor":"New York State Psychiatric Institute","startDate":"2021-03-19","conditions":"Bipolar Disorder","enrollment":""},{"nctId":"NCT02113163","phase":"PHASE1","title":"PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA","status":"COMPLETED","sponsor":"Thetis Pharmaceuticals LLC","startDate":"2014-03","conditions":"Diabetes Mellitus, Non-Insulin-Dependent, Hypertriglyceridemia","enrollment":32},{"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":"NCT02422446","phase":"PHASE3","title":"Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects","status":"TERMINATED","sponsor":"Brigham and Women's Hospital","startDate":"2015-04","conditions":"Type 2 Diabetes, Coronary Artery Disease","enrollment":2},{"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":"NCT04177680","phase":"PHASE2","title":"Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia","status":"COMPLETED","sponsor":"Matinas BioPharma Nanotechnologies, Inc.","startDate":"2020-06-03","conditions":"Hypertriglyceridemia","enrollment":100},{"nctId":"NCT04412018","phase":"PHASE2","title":"An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19","status":"COMPLETED","sponsor":"Canadian Medical and Surgical Knowledge Translation Research Group","startDate":"2020-06-04","conditions":"COVID-19, Inflammatory Response","enrollment":100},{"nctId":"NCT03661047","phase":"PHASE2","title":"OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer","status":"WITHDRAWN","sponsor":"Massachusetts General Hospital","startDate":"2019-11-30","conditions":"Colon Cancer","enrollment":""},{"nctId":"NCT03885661","phase":"PHASE1","title":"Vascepa to Accelerate Lipoprotein Uptake and Elimination","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2016-01-11","conditions":"Lipid Disorder, Triglycerides High, Dyslipidemias","enrollment":20},{"nctId":"NCT04460651","phase":"PHASE3","title":"PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial","status":"COMPLETED","sponsor":"Estudios Clínicos Latino América","startDate":"2020-08-14","conditions":"COVID19","enrollment":4093},{"nctId":"NCT02940223","phase":"PHASE2","title":"Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","startDate":"2017-03-16","conditions":"Advanced Malignant Neoplasm, Fatigue","enrollment":2},{"nctId":"NCT04761952","phase":"NA","title":"N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease","status":"UNKNOWN","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","startDate":"2021-02-13","conditions":"Inflammatory Bowel Diseases, Crohn Disease, Polyunsaturated Acid Lipidosis","enrollment":236},{"nctId":"NCT02708771","phase":"PHASE3","title":"Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity","status":"COMPLETED","sponsor":"Hospital San Juan de la Cruz","startDate":"2016-03","conditions":"Heart Failure","enrollment":42},{"nctId":"NCT03693131","phase":"PHASE3","title":"Efficacy of MND-2119 in Participants With Hypertriglyceridemia","status":"COMPLETED","sponsor":"Mochida Pharmaceutical Company, Ltd.","startDate":"2018-10-27","conditions":"Hypertriglyceridemia","enrollment":580},{"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":"NCT02859129","phase":"PHASE1","title":"Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2013-09","conditions":"Hypertriglyceridemia","enrollment":114},{"nctId":"NCT00231738","phase":"PHASE4","title":"Protective Effect of EPA on Cardiovascular Events","status":"COMPLETED","sponsor":"Kobe University","startDate":"1996-11","conditions":"Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease","enrollment":18000},{"nctId":"NCT01817400","phase":"EARLY_PHASE1","title":"Mediators of Abnormal Reproductive Function in Obesity (MARO)","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2013-03","conditions":"Infertility, Female, Obesity","enrollment":10},{"nctId":"NCT01154985","phase":"PHASE2","title":"Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)","status":"COMPLETED","sponsor":"Mochida Pharmaceutical Company, Ltd.","startDate":"2010-06","conditions":"Steatohepatitis","enrollment":243},{"nctId":"NCT00634361","phase":"PHASE2, PHASE3","title":"Ethyl-EPA Treatment of Prodromal Patients","status":"COMPLETED","sponsor":"Yale University","startDate":"2001-09","conditions":"Schizophrenia Prodrome","enrollment":7},{"nctId":"NCT00069784","phase":"PHASE3","title":"The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2003-08","conditions":"Diabetes Mellitus, Non-Insulin-Dependent","enrollment":12537},{"nctId":"NCT01369550","phase":"NA","title":"Efficacy Study of Stearidonic Acid (SDA) Soybean Oil-containing Foods on Red Blood Cell Fatty Acid Content","status":"COMPLETED","sponsor":"Monsanto Company, LLC","startDate":"2010-08","conditions":"Healthy Volunteers, Markers of Cardiovascular Risk","enrollment":127},{"nctId":"NCT00419146","phase":"PHASE2, PHASE3","title":"Treatment of Schizophrenia With an Omega-3 Fatty Acid (EPA) and Antioxidants","status":"COMPLETED","sponsor":"University Hospital, Aker","startDate":"2001-09","conditions":"Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorder","enrollment":99},{"nctId":"NCT00839449","phase":"PHASE4","title":"Eicosapentaenoic Acid Cerebral Vasospasm Therapy Study","status":"COMPLETED","sponsor":"Yamaguchi University Hospital","startDate":"2004-12","conditions":"Subarachnoid Hemorrhage, Cerebral Vasospasm","enrollment":200},{"nctId":"NCT00692718","phase":"PHASE4","title":"N-3 Fatty Acids for the Prevention of Atrial Fibrillation in Patients With Acute Heart Failure","status":"UNKNOWN","sponsor":"Osaka General Medical Center","startDate":"2008-07","conditions":"Acute Heart Failure, Acute Myocardial Infarction","enrollment":160},{"nctId":"NCT00001146","phase":"PHASE2","title":"Omega-3 Fatty Acids in the Treatment of Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial","status":"COMPLETED","sponsor":"National Institute of Mental Health (NIMH)","startDate":"1999-10","conditions":"Bipolar Disorder, Involutional Depression, Mood Disorder","enrollment":240},{"nctId":"NCT00096798","phase":"PHASE3","title":"Ethyl Eicosapentanoic Acid (Ethyl-EPA) for Treating Major Depression","status":"COMPLETED","sponsor":"National Center for Complementary and Integrative Health (NCCIH)","startDate":"2001-09","conditions":"Depressive Disorder, Depression","enrollment":80},{"nctId":"NCT00146211","phase":"PHASE3","title":"TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease","status":"COMPLETED","sponsor":"Amarin Neuroscience Ltd","startDate":"2005-09","conditions":"Huntington Disease","enrollment":300}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["VASCEPA","VASCEPA® (icosapent ethyl)"],"phase":"phase_3","status":"active","brandName":"AMR101","genericName":"AMR101","companyName":"Massachusetts General Hospital","companyId":"massachusetts-general-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"AMR101 is a high-purity eicosapentaenoic acid (EPA) that reduces triglycerides by inhibiting hepatic triglyceride synthesis and enhancing fatty acid oxidation. Used for Hypertriglyceridemia in patients on statin therapy with elevated triglycerides.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}