24 completed, 4 terminated, 3 withdrawn, 2 active not recruiting. 16 Phase 3, 11 Phase 2, 8 Phase 4, 5 Phase 1, 2 Not applicable.
Follow eicosapentaenoic acid ethyl ester: new trials by email Literature Review of eicosapentaenoic acid ethyl ester trials Research Report on eicosapentaenoic acid ethyl ester
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Icosapent Ethyl for High-Risk Coronary Plaques Assessed by 18F-NaF PET/CT icosapent ethyl (IPE), Standard LDL-C-Lowering Therapy - Coronary Artery Disease, Hyperlipidaemia | Phase 4 | Not yet recruiting | China National Center for Cardiovascular Diseases | 100 | 2026-08-01 | 2026-08-13 |
| A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia DR10624 Subcutaneous Injection, Icosapent Ethyl Oral Capsule, Matching Placebo Subcutaneous Injection - Severe Hypertriglyceridemia | Phase 3 | Not yet recruiting | Zhejiang Doer Biologics Co., Ltd. | 378 | 2026-08-01 | 2026-07-06 |
| Targeting Vascular INflammation in Patients With Community-Acquired Pneumonia Icosapent Ethyl 1000 MG Oral Capsule [Vascepa], Placebo - Inflammation, Community Acquired Pneumonia (CAP) | Phase 3 | Recruiting | Ottawa Heart Institute Research Corporation | 168 | 2026-04-08 | 2026-05-11 |
| 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 CreNeuroS CNS Fish Oil Plus Softgel [380 mg of fish oil contains Eicosapentaenoic Acid (EPA) (as EE)342 mg; L-5- Methyltetrahydrofolate 1.875 mg; other Vitamins and Minerals], Vascepa® (Icosapent ethyl) 1000 mg Capsules, Deplin® (L-methylfolate Calcium) 7.5 mg Capsules - Bioavailability | Not applicable | Enrolling by invitation | Sichuan Credit Pharmaceutical Co., Ltd. | 14 | 2025-01-03 | 2025-01-23 |
| Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) Statin, Aspirin tablet, Nexlizet - Coronary Artery Disease, Atherosclerosis | Phase 4 | Withdrawn | University of Louisville | 2024-03-01 | 2025-03-17 | |
| IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion Icosapent ethyl, Placebo - Aortic Valve Stenosis | Phase 2 | Active not recruiting | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 110 | 2023-06-01 | 2025-10-03 |
| 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 Dasatinib, Icosapent Ethyl - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Inflammatory Carcinoma | Phase 1 / Phase 2 | Terminated | National Cancer Institute (NCI) | 1 | 2022-11-08 | 2025-10-03 |
| Prebiotic Effect of Eicosapentaenoic Acid Treatment for Colorectal Cancer Liver Metastases Icosapent Ethyl Oral Capsule, Placebo - Colon Cancer Liver Metastasis | Completed | University of Leeds | 81 | 2021-09-16 | 2024-12-04 | |
| A PET Study With [11C]PBR-28 and an Experimental Medication, Ethyl Eicosapentaenoic Acid Ethyl Eicosapentaenoic Acid - Bipolar Disorder | Phase 4 | Withdrawn | New York State Psychiatric Institute | 2021-03-19 | 2022-10-14 | |
| PRevention Using EPA Against coloREctal Cancer AMR101 - Colorectal Adenoma, Colorectal Cancer | Phase 1 / Phase 2 | Completed | Massachusetts General Hospital | 81 | 2020-12-09 | 2024-05-03 |
| The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] - Cardiovascular Diseases, Cardiovascular Risk Factor | Phase 4 | Completed | Canadian Medical and Surgical Knowledge Translation Research Group | 70 | 2020-09-24 | 2024-04-02 |
| PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial Icosapent ethyl (IPE), Placebo - COVID19 | Phase 3 | Completed | Estudios Clínicos Latino América | 4093 | 2020-08-14 | 2021-09-17 |
| A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults Icosapent ethyl - Covid19, Atherosclerosis | Phase 4 | Terminated | Kaiser Permanente | 39600 | 2020-08-07 | 2023-07-18 |
| An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19 Icosapent ethyl - COVID-19, Inflammatory Response | Phase 2 | Completed | Canadian Medical and Surgical Knowledge Translation Research Group | 100 | 2020-06-04 | 2021-12-22 |
| Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia Omega 3 pentaenoic acid, icosapent ethyl - Hypertriglyceridemia | Phase 2 | Completed | Matinas BioPharma Nanotechnologies, Inc. | 100 | 2020-06-03 | 2022-03-04 |
| OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer AMR101 (VASCEPA, icosapent ethyl) - Colon Cancer | Phase 2 | Withdrawn | Massachusetts General Hospital | 2019-11-30 | 2021-11-17 | |
| The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism Ethyl-Eicosapentaenoic Acid (E-EPA) - Atherosclerosis, Low-density Lipoproteins Aggregation Susceptibility | Not applicable | Completed | Wihuri Research Institute | 68 | 2019-11-12 | 2025-09-22 |
| Efficacy of MND-2119 in Participants With Hypertriglyceridemia Icosapent (MND-2119), Icosapent (EPADEL CAPSULES 300) - Hypertriglyceridemia | Phase 3 | Completed | Mochida Pharmaceutical Company, Ltd. | 580 | 2018-10-27 | 2019-08-01 |
| EPA for Metastasis Trial 2 Icosapent Ethyl, Placebo - Liver Metastasis, Colon Cancer | Phase 3 | Active not recruiting | Mark A Hull, PhD FRCP | 418 | 2018-05-02 | 2025-04-18 |
| Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid icosapent ethyl (IPE), gel cap placebo - Alzheimer's Disease | Phase 2 / Phase 3 | Completed | VA Office of Research and Development | 131 | 2017-06-08 | 2024-11-26 |
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Hypertriglyceridemia (15) · Dyslipidemias (5) · Cardiovascular Diseases (4) · Coronary Artery Disease (4) · Atherosclerosis (3) · COVID-19 (3) · Colonic Neoplasms (3) · Diabetes Mellitus, Type 2 (3) · Bipolar Disorder (2) · Colorectal Neoplasms (2) · Vascular Diseases (2) · Acute Coronary Syndrome (1) · Alzheimer Disease (1) · Angina Pectoris (1) · Aortic Valve Stenosis (1)
Amarin Pharma Inc. (3) · Canadian Medical and Surgical Knowledge Translation Research Group (2) · Massachusetts General Hospital (2) · Takeda (2) · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (1) · Amarin Neuroscience Ltd (1) · AstraZeneca (1) · Brigham and Women's Hospital (1) · China National Center for Cardiovascular Diseases (1) · Estudios Clínicos Latino América (1) · Kaiser Permanente (1) · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (1) · M.D. Anderson Cancer Center (1) · Mark A Hull, PhD FRCP (1) · Matinas BioPharma Nanotechnologies, Inc. (1)
United States (20) · Canada (5) · India (3) · Netherlands (3) · China (2) · Finland (2) · Japan (2) · Russia (2) · South Africa (2) · Ukraine (2) · United Kingdom (2) · Argentina (1) · Australia (1) · Denmark (1) · Germany (1)
Associate Professor, Clinical Cell Biology and Medicine (2) · Mark Hull (2) · Subodh Verma, MD, PhD (2) · Andrew T. Chan, MD, MPH (1) · Blair Leavitt, MD (1) · Christopher Ross, MD, PhD (1) · Cynthia M. Carlsson, MD MS (1) · David A Hess, PhD (1) · David Mischoulon, MD, PhD (1) · Deepak L Bhatt, MD, MPH (1) · Deepak L. Bhatt, MD, MPH (1) · Dinesh Kalra, MD (1) · Ira Shoulson, MD (1) · Jianping Li (1)
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