Clinical Trials

Numerous clinical trials, ranging from Early Phase 1 through Phase 4, evaluate the therapeutic potential of Eicosapentaenoic Acid (EPA) across diverse indications, including cardiovascular diseases, atherosclerosis, morbid obesity, type 2 diabetes, major depressive disorder, CADASIL, and parenteral nutrition-associated liver disease. Conducted by academic, medical, and corporate entities such as Brigham and Women's Hospital, Fresenius Kabi, Wihuri Research Institute, and the University of Toronto, these studies encompass completed, active, and terminated recruitment statuses. Their scope spans a broad array of clinical endpoints, from adult lipid metabolism to prospective pediatric safety evaluations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07261423 RECRUITING
Childhood Asthma; Asthma Control; Asthma Exacerbation; Air Pollution, Risk Reduction Behaviors
University of Pittsburgh
 2026-02-24
NCT07575438 NOT_YET_RECRUITING
Type 2 Diabetes; Prediabetes (Insulin Resistance, Impaired Glucose Tolerance); Prediabetes / Type 2 Diabetes; Obesity & Overweight; Obesity and Diabetes Mellitus, Type 2
May Faraj, PDt, PhD
 2026-07 PHASE2
NCT06933095 RECRUITING
Eldery People; Cognitive Decline; Memory Decline; DHA CNS Delivery
University of Cincinnati
 2024-09-15
NCT06736925 RECRUITING
Subconcussive Head Impact; Omega-3 Fatty Acids
Indiana University
 2025-02-28
NCT00682318 ACTIVE_NOT_RECRUITING
Healthy
Carsten Skarke, MD
 2008-05
NCT07462013 RECRUITING
Major Depressive Disorder (MDD)
National Science and Technology Council, Taiwan
 2025-10-01
NCT06494488 RECRUITING
Lipid Metabolism Disorders; Hypertriglyceridemia
The Miriam Hospital
 2025-07-10 EARLY_PHASE1
NCT07270198 NOT_YET_RECRUITING
Diabetic Kidney Disease (DKD)
Mario Negri Institute for Pharmacological Research
 2026-02
NCT07272382 RECRUITING
Esophageal Neoplasms
Fudan University
 2025-06-05
NCT06695910 RECRUITING
Brain Fog; Cognitive Health
Samuel Fortin
 2024-11-06 PHASE4
NCT07439744 RECRUITING
Obese Adults; MDD
National Science and Technology Council, Taiwan
 2025-03-01
NCT07255066 NOT_YET_RECRUITING
Malnutrition (Calorie); Colorectal Cancer; Lung Cancer
University of Edinburgh
 2026-06
NCT06710080 RECRUITING
Inflammation; Community Acquired Pneumonia (CAP); Inflammation Plaque, Atherosclerotic
Ottawa Heart Institute Research Corporation
 2026-04-08 PHASE3
NCT07753174 RECRUITING
Omega-3 Deficiency; DHA and EPA Blood Levels; Cardiovascular Health; Cognitive Health
Revive Active
 2026-09
NCT07241377 ACTIVE_NOT_RECRUITING
Absorption of Omega-3; Omega-3 Supplementation; Healthy Participants
RDC Clinical Pty Ltd
 2025-10-27 PHASE3
NCT06629103 ACTIVE_NOT_RECRUITING
Optimal Absorption of Omega-3; Healthy
RDC Clinical Pty Ltd
 2025-08-06 PHASE4
NCT07118059 NOT_YET_RECRUITING
Tuberculosis; Inflammation Biomarkers; Liver Function Tests; Iron Status; Metabolomics; Nutritional Status; Clinical Outcomes
North-West University, South Africa
 2025-08 PHASE2
NCT05949190 ACTIVE_NOT_RECRUITING
Malnutrition in Pregnancy; Preterm Birth; Child Development; Postpartum Depression; Antepartum Depression
Washington University School of Medicine
 2023-08-18
NCT06928701 RECRUITING
Early Breast Cancer; Neoadjuvant Treatment
University of Eastern Piedmont
 2024-09-01
NCT06975241 RECRUITING
Healthy; Omega 3; Metabolism, Lipids
University of Toronto
 2025-07-29 PHASE4
NCT07673185 RECRUITING
Periodontal Disease; Periodontitis (Stage 3); Smoking Behaviors
Al-Azhar University
 2025-01-15
NCT05802797 ACTIVE_NOT_RECRUITING
Healthy Diet
Ohio State University Comprehensive Cancer Center
 2023-04-03 EARLY_PHASE1
NCT07393399 NOT_YET_RECRUITING
Lupus Erythematosus, Systemic
University of Sao Paulo
 2026-07
NCT07363551 RECRUITING
ADHD
China Medical University Hospital
 2021-06-09
NCT07461649 NOT_YET_RECRUITING
Bioavailability and Pharmacokinetics
Sichuan Credit Pharmaceutical Co., Ltd.
 2026-03-15
NCT06981676 RECRUITING
Maternal Obesity; Obesity
Pontificia Universidad Catolica de Chile
 2023-07-25
NCT06899074 COMPLETED
Migraine
University of North Carolina, Chapel Hill
 2025-04-17
NCT07289919 ACTIVE_NOT_RECRUITING
Cardiovascular (CV) Risk; Atheroscleroses; Inflamation; Omega 3 Fatty Acids; Supplement
University of Sao Paulo
 2025-05-26
NCT07634133 ENROLLING_BY_INVITATION
Healthy Volunteers
The Jerzy Kukuczka Academy of Physical Education in Katowice
 2025-04-15
NCT06507605 COMPLETED
Prevention of Malaria Transmission and Clinical Malaria
Serum Institute of India Pvt. Ltd.
 2024-08-30 PHASE1
NCT03308916 RECRUITING
Liver Diseases, Alcoholic; Fibrosis
Maja Thiele
 2017-10-06
NCT07711444 COMPLETED
COVID - 19; Depression - Major Depressive Disorder
National Science and Technology Council, Taiwan
 2024-06-01
NCT06992323 ACTIVE_NOT_RECRUITING
Hypertriglyceridemia; Normal
National Research Council, Spain
 2025-02-17
NCT03428477 ACTIVE_NOT_RECRUITING
Liver Metastasis; Colon Cancer
Mark A Hull, PhD FRCP
 2018-05-02 PHASE3
NCT05739955 COMPLETED
Disinfection
Duke University
 2023-02-13
NCT05913973 COMPLETED
Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
 2023-08-04 PHASE1
NCT06833554 RECRUITING
Gestational Diabetes Mellitus (GDM)
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
 2023-01-01
NCT07127068 ACTIVE_NOT_RECRUITING
Omega 3 Fatty Acids; Coronary Arterial Disease (CAD); Chronic Kidney Disease(CKD)
University of Beykent
 2024-06-01
NCT06627114 COMPLETED
Non-alcoholic Fatty Liver Disease (NAFLD); Omega-3 Supplementation; Nutrition Education Program
Hawler Medical University
 2024-10-29
NCT06731400 NOT_YET_RECRUITING
Atherosclerosis Cardiovascular Disease
University of Sao Paulo
 2024-12-03
NCT06294067 COMPLETED
Nutrition, Healthy
University of Toronto
 2024-02-26 PHASE1
NCT07768423 RECRUITING
Physical Performance; Cognitive Function; Sports Nutrition
The Jerzy Kukuczka Academy of Physical Education in Katowice
 2025-01-07
NCT06758778 ENROLLING_BY_INVITATION
Bioavailability
Sichuan Credit Pharmaceutical Co., Ltd.
 2025-01-03
NCT06280976 WITHDRAWN
Coronary Artery Disease; Atherosclerosis; Heart Attack
University of Louisville
 2024-03-01 PHASE4
NCT05950204 UNKNOWN
Acute Lymphoblastic Leukemia; Vitamin d Deficiency
Coordinación de Investigación en Salud, Mexico
 2022-09-10
NCT03576989 COMPLETED
Chronic Venous Leg Ulcers
Ohio State University
 2019-04-15
NCT06735222 COMPLETED
Healthy; Young
National Research Council, Spain
 2024-11-18
NCT06157398 COMPLETED
Healthy Individuals
University of British Columbia
 2024-01-29
NCT06129526 UNKNOWN
Diabetes Type 2; Hypertriglyceridemia; Diabetes Mellitus
University of Ioannina
 2023-12 PHASE4
NCT04152291 COMPLETED
Atherosclerosis; Low-density Lipoproteins Aggregation Susceptibility; Low-density Lipoprotein Lipid Composition; Cardiovascular Diseases
Wihuri Research Institute
 2019-11-12
NCT03806426 UNKNOWN
Familial Adenomatous Polyposis
S.L.A. Pharma AG
 2018-12-05 PHASE3
NCT06840964 COMPLETED
Hypertension; Dyslipidemia
Santa Maria de la Salud, Argentina
 2023-03-23
NCT05763940 UNKNOWN
Dry Eye Syndromes; Age-Related Macular Degeneration; Omega 3 Index
Western University of Health Sciences
 2022-05-25
NCT06274788 Not yet recruiting
Parenteral Nutrition Associated Liver Disease (PNALD)|Essential Fatty Acid Deficiency|Malnutrition|Pediatric ALL
Fresenius Kabi
 2024-05-01 Phase 4
NCT05702346 WITHDRAWN
Physical Activity
Boston University Charles River Campus
 2023-12-01
NCT05198843 TERMINATED
Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Inflammatory Carcinoma
National Cancer Institute (NCI)
 2022-11-08 PHASE1; PHASE2
NCT03753334 ACTIVE_NOT_RECRUITING
Prostate Cancer
CHU de Quebec-Universite Laval
 2017-07-10 PHASE2
NCT06120985 Recruiting
Water-Related Diseases|Enteric Pathogens|Exposure to Chemical Pollution
Virginia Polytechnic Institute and State University|East Tennessee State University|University of North Carolina Chapel Hill|Ballad Health
 2023-11-19 Not Applicable
NCT05755997 Recruiting
Cadasil
Ever Neuro Pharma GmbH|idv Datenanalyse & Versuchsplanung|XClinical GmbH
 2023-11-29 Phase 2
NCT04844034 UNKNOWN
Anxiety; Depression
University of Roehampton
 2022-04-19
NCT07664007 COMPLETED
Hepatocellular Carcinoma
Instituto de Investigación Sanitaria Aragón
 2019-03-04
NCT07304921 COMPLETED
Lipid Metabolism; Omega-3 Polyunsaturated Fatty Acids; Supplementation
Riga Stradins University
 2023-04-06 PHASE1
NCT04222660 COMPLETED
Diabetic Peripheral Neuropathy
VA Office of Research and Development
 2021-06-21
NCT04562467 COMPLETED
Cardiovascular Diseases; Cardiovascular Risk Factor; Triglycerides High; Diabetes Mellitus, Type 2
Canadian Medical and Surgical Knowledge Translation Research Group
 2020-09-24 PHASE4
NCT03143075 COMPLETED
Major Depressive Disorder
Region Skane
 2017-08-01
NCT05121766 TERMINATED
COVID-19
Hackensack Meridian Health
 2022-01-10 PHASE1
NCT04897893 COMPLETED
Inflammation
SCF Pharma
 2021-04-21 PHASE4
NCT05135273 COMPLETED
Malaria,Falciparum
National Institute of Allergy and Infectious Diseases (NIAID)
 2021-10-22 PHASE1
NCT03972319 UNKNOWN
Fatty Liver; Bariatric Surgery Candidate
Khoo Teck Puat Hospital
 2019-09-17 EARLY_PHASE1
NCT04216251 COMPLETED
Colorectal Adenoma; Colorectal Cancer; Endoscopic Surgery; Eicosapentaenoic Acid; Gastrointestinal Microbiome
Massachusetts General Hospital
 2020-12-09 PHASE1; PHASE2
NCT05438173 COMPLETED
Bioavailability
Midwest Center for Metabolic and Cardiovascular Research
 2022-07-11
NCT04811404 WITHDRAWN
Bipolar Disorder
New York State Psychiatric Institute
 2021-03-19 PHASE4
NCT06738446 COMPLETED
Dry Eye Syndrome (DES)
Shih Chien Huang
 2021-09-27
NCT03040856 WITHDRAWN
Omega 3 Supplements During Pregnancy
Sheba Medical Center
 2022-02-01
NCT04743050 UNKNOWN
Fatty Acids; Alpha-Linolenic Acid; Docosahexaenoic Acids; Eicosapentaenoic Acid; Preventive Health Services; Preventive Medicine; Cardiovascular Diseases; Anti-Inflammatory Agents
Wroclaw Medical University
 2020-12-09 PHASE3
NCT04828538 WITHDRAWN
Covid19
Hospital de la Soledad
 2021-01-01
NCT04386525 UNKNOWN
Ischemic Stroke; Neurological Injury; Stroke, Acute; Inflammatory Response; Permanent Injury; Neurologic Dysfunction; Neurological Disorder; Brain Ischemia; Brain Injuries
King Fahad Medical City
 2020-09-01 PHASE4
NCT05068557 UNKNOWN
Obesity; Chronic Inflammation
University of Guadalajara
 2021-09-24
NCT04335032 UNKNOWN
SARS-CoV-2
S.L.A. Pharma AG
 2021-01-08 PHASE3
NCT03661047 WITHDRAWN
Colon Cancer
Massachusetts General Hospital
 2019-11-30 PHASE2
NCT02681601 TERMINATED
Cancer of Pancreas
Jonsson Comprehensive Cancer Center
 2016-07-19
NCT04460651 COMPLETED
COVID19
Estudios Clínicos Latino América
 2020-08-14 PHASE3
NCT03917654 COMPLETED
Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
 2019-04-24 PHASE2
NCT03345550 TERMINATED
Mild Traumatic Brain Injury
University of Michigan
 2017-09-12 PHASE2
NCT04006847 TERMINATED
Chronic Myeloid Leukemia, Chronic Phase
Milton S. Hershey Medical Center
 2020-09-14 PHASE1; PHASE2
NCT04477395 COMPLETED
Periodontitis; Therapeutics; Fatty Acids, Unsaturated
Medical University of Lodz
 2017-11-01
NCT04159532 COMPLETED
Healthy Adults
SCF Pharma
 2019-12-18 PHASE4
NCT04687124 UNKNOWN
Abdominal Cancer; Radiotherapy; Complications; Weight Loss; Energy Supply; Protein Deficiency
Jens Rikardt Andersen
 2018-02-15 PHASE4
NCT04570995 TERMINATED
Brain Health; Brain Function; Brain Development
Wake Forest University Health Sciences
 2020-11-05
NCT02333435 ACTIVE_NOT_RECRUITING
Prostate Cancer
CHU de Quebec-Universite Laval
 2015-02-12 PHASE2
NCT04412018 COMPLETED
COVID-19; Inflammatory Response
Canadian Medical and Surgical Knowledge Translation Research Group
 2020-06-04 PHASE2
NCT04301336 COMPLETED
Vaso-occlusive Crisis; Sickle Cell Disease; Sickle Cell Anemia in Children
Beni-Suef University
 2019-11-01 PHASE2; PHASE3
NCT03657758 UNKNOWN
Coronary Artery Disease; Angina Pectoris
Kobe University
 2018-09-17 PHASE4
NCT02942277 COMPLETED
Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
 2016-10-21 PHASE1
NCT05219890 WITHDRAWN
Obesity; Inflammation; Immune System Disorder
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2017-01-16
NCT02926027 COMPLETED
Hypertriglyceridemia
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
 2017-03-28 PHASE4
NCT02670382 COMPLETED
Metabolic Syndrome
Tufts University
 2016-03
NCT03796455 COMPLETED
Chronic Obstructive Pulmonary Disease
Texas A&M University
 2018-04-25
NCT03691519 COMPLETED
Alzheimer Disease
University Hospital, Toulouse
 2018-04-17 PHASE3
NCT04058002 UNKNOWN
Knee Osteoarthritis
University of Sao Paulo General Hospital
 2019-08-15
NCT04796207 COMPLETED
Traumatic Brain Injury (TBI); Chronic Traumatic Encephalopathy (CTE)
University of Arizona
 2019-05-28
NCT04496154 COMPLETED
Type 2 Diabetes; Insulin Sensitivity/Resistance; Inflammatory Response; Fatty Acids, Omega-3
May Faraj, PDt, PhD
 2013-09-05
NCT01270516 COMPLETED
Muscle Weakness
Gerald Supinski
 2014-01
NCT03483090 COMPLETED
Osteoarthritis, Knee
Swisse Wellness Pty Ltd
 2018-02-27 PHASE2
NCT03915535 TERMINATED
Healthy Athletes
Samuel Fortin
 2019-09-19 PHASE4
NCT02271230 COMPLETED
Heart Failure
Brigham and Women's Hospital
 2014-08 PHASE3
NCT03708120 COMPLETED
Tick Bites
ARCTEC
 2018-11-15
NCT03801577 UNKNOWN
Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; NASH - Nonalcoholic Steatohepatitis
BASF AS
 2019-02
NCT02498106 COMPLETED
Psychiatric Hospitalization
Leiden University Medical Center
 2015-05
NCT03598413 COMPLETED
Colorectal Cancer; Nutritional Deficiency; Infected Wound; Surgical Site Infection; Complication, Postoperative; Surgery; Surgery--Complications; Sarcopenia; Phagocytic Dysfunction
Royal Surrey County Hospital NHS Foundation Trust
 2018-07-16
NCT03735836 COMPLETED
Pharmacokinetic in Normal Population
Samuel Fortin
 2018-08-08 PHASE4
NCT02514070 COMPLETED
Lipoprotein Metabolism; PCSK9; Proteomics
National Heart, Lung, and Blood Institute (NHLBI)
 2015-10-30 PHASE2
NCT03694314 COMPLETED
Disturbances in Initiating and Maintaining Sleep; Behavior Problem
University of Pennsylvania
 2018-05-15
NCT03693131 COMPLETED
Hypertriglyceridemia
Mochida Pharmaceutical Company, Ltd.
 2018-10-27 PHASE3
NCT03742492 UNKNOWN
Healthy Volunteers
Universidade do Porto
 2018-09-19 PHASE2
NCT03781557 UNKNOWN
Cognition; Brain; Neuroscience
Sulaiman AlRajhi Colleges
 2019-01-01 PHASE4
NCT03151291 UNKNOWN
Cancer; Cancer Cachexia; Weight Loss; Muscle Loss; Muscle Weakness
University of Erlangen-Nürnberg Medical School
 2016-12
NCT03159507 COMPLETED
Healthy
SCF Pharma
 2017-10-02 PHASE4
NCT02715596 COMPLETED
Squamous Cell Carcinoma of Head and Neck
Institut Català d'Oncologia
 2015-12-23 PHASE3
NCT02705430 UNKNOWN
Type 2 Diabetes
Rabin Medical Center
 2018-06-20
NCT03592251 COMPLETED
Memory Consolidation
Northumbria University
 2017-08-01
NCT02763514 COMPLETED
Cognitive Function
Northumbria University
 2016-10
NCT01351805 COMPLETED
Autoimmune Diseases; Systemic Inflammatory Process; Knee Pain Chronic; Osteoarthritis; Rheumatoid Arthritis
Brigham and Women's Hospital
 2010-07
NCT02947100 TERMINATED
Sickle Cell Disease
Robin E. Miller
 2018-01-25 PHASE1; PHASE2
NCT03906825 COMPLETED
Inflammation; Endothelial Dysfunction
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
 2018-05-17
NCT03885661 COMPLETED
Lipid Disorder; Triglycerides High; Dyslipidemias
University of Pennsylvania
 2016-01-11 PHASE1
NCT01251887 COMPLETED
Weight Gain; Healthy Subjects; Obesity; Women
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2010-11-12
NCT02553915 COMPLETED
Major Depressive Disorder; Overweight; Inflammation
Massachusetts General Hospital
 2015-12 PHASE2; PHASE3
NCT04972643 COMPLETED
Alzheimer Disease; Dementia Disorder
Taichung Veterans General Hospital
 2012-09-23
NCT01492361 COMPLETED
Cardiovascular Diseases
Amarin Pharma Inc.
 2011-11 PHASE3
NCT03443076 COMPLETED
Bioavailability
Midwest Center for Metabolic and Cardiovascular Research
 2018-02-16
NCT02321631 COMPLETED
Head and Neck Cancer
Prince of Songkla University
 2015-01
NCT03559361 COMPLETED
Sleep
Northumbria University
 2017-03-01
NCT02848469 UNKNOWN
Psychotic Disorders
University College Cork
 2013-09 PHASE2
NCT01821833 COMPLETED
Breast Cancer; Ovarian Neoplasm; Pain
New Mexico Cancer Research Alliance
 2016-05-24
NCT00420602 COMPLETED
Dominantly Inherited Stargardt's Disease (STGD3)
University of Utah
 2007-09-21
NCT03961763 COMPLETED
Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias
University of Chester
 2017-06-01
NCT04210804 COMPLETED
Bipolar Depression
National University of Ireland, Galway, Ireland
 2014-04-01 PHASE2
NCT03158545 COMPLETED
Neurovascular Coupling
Northumbria University
 2016-10-10
NCT01956188 UNKNOWN
Systemic Lupus Erythematosus; Primary Antiphospholipid Syndrome
University of Sao Paulo
 2014-05
NCT03192579 COMPLETED
Coronary Artery Disease Progression
Kobe University
 2013-07-26 PHASE4
NCT03378232 COMPLETED
Cardiovascular Disease
University of Guelph
 2017-01-05
NCT02422446 TERMINATED
Type 2 Diabetes; Coronary Artery Disease
Brigham and Women's Hospital
 2015-04 PHASE3
NCT01826422 COMPLETED
Muscular Dystrophy, Duchenne
Coordinación de Investigación en Salud, Mexico
 2013-03
NCT03317171 COMPLETED
Muscular Dystrophies; Muscle Inflammation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
 2016-02-28
NCT03017651 COMPLETED
Overweight and Obesity
Société des Produits Nestlé (SPN)
 2016-11 PHASE1
NCT02661698 COMPLETED
Lipid Absorption and Metabolism
Northumbria University
 2016-02
NCT02179372 COMPLETED
Ulcerative Colitis; Crohn's Disease
IRCCS Azienda Ospedaliero-Universitaria di Bologna
 2014-06
NCT02532023 UNKNOWN
Migraine
Tehran University of Medical Sciences
 2015-09 PHASE4
NCT01624792 COMPLETED
Chronic Obstructive Pulmonary Disease; Muscle Wasting
Texas A&M University
 2011-10-25
NCT01828502 WITHDRAWN
Pediatric Cancer
University of South Florida
 2013-10 PHASE2
NCT02637778 COMPLETED
Cardiovascular Diseases
University of Jena
 2016-02
NCT01896414 COMPLETED
Metabolic Syndrome
University of Maryland, Baltimore
 2014-07
NCT02057406 COMPLETED
Depression
Wei Jiang
 2014-05 PHASE3
NCT03499535 COMPLETED
Lung Neoplasms; Radon Exposure; Smoking; Intention; Risk Reduction Behavior
Paul Windschitl
 2015-08-07
NCT01936779 COMPLETED
NAFLD
University of Oxford
 2013-09
NCT02334462 COMPLETED
Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
 2015-01-07 PHASE1
NCT02540759 COMPLETED
Healthy
Réseau de Santé Vitalité Health Network
 2015-09 PHASE1
NCT01867463 COMPLETED
Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
 2013-03-27 PHASE1
NCT00167310 COMPLETED
Schizophrenia; Schizoaffective Disorder; Major Depression; Bipolar Disorder; Coronary Artery Disease
University of Pittsburgh
 2005-09 PHASE2
NCT02208700 UNKNOWN
Acute Lung Injury; Mechanical Ventilation Complication; Dietary Modification
Grace Hospital, Cleveland, Ohio
 2014-01
NCT02195609 COMPLETED
Menopause; Hot Flashes
Instituto Palacios
 2014-03 PHASE4
NCT02069561 COMPLETED
Ulcerative Colitis
IRCCS Azienda Ospedaliero-Universitaria di Bologna
 2014-01
NCT02359045 COMPLETED
Relative Bioavailability; AUC; Cmax; Pharmacokinetics
AstraZeneca
 2015-02-12 PHASE1
NCT01810003 COMPLETED
Cardiovascular Disease, Inflammation
Laval University
 2013-03
NCT02062528 COMPLETED
Hot Flashes; Fatty Acids; Menopause
Vivatech
 2014-03
NCT02372344 COMPLETED
Healthy
AstraZeneca
 2015-03 PHASE1
NCT02865044 COMPLETED
Healthy
Calanus
 2015-03
NCT01056133 COMPLETED
Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis
Johane Allard
 2009-10 PHASE2
NCT02615405 COMPLETED
Major Depressive Disorder
National Science and Technology Council, Taiwan
 2012-08
NCT02009865 COMPLETED
Hypertriglyceridemia
AstraZeneca
 2013-12-16 PHASE3
NCT01997268 WITHDRAWN
Severe Hypertriglyceridemia
Sancilio and Company, Inc.
 PHASE3
NCT01504633 UNKNOWN
Cognitive Ability, General
Indonesia University
 2011-12
NCT01761942 UNKNOWN
Anorexia Nervosa
Institute of Psychiatry and Neurology, Warsaw
 2012-09 PHASE2
NCT01936194 WITHDRAWN
Atopic Dermatitis
Mead Johnson Nutrition
 2013-09
NCT03364699 COMPLETED
Immune Dysfunction
University of Sao Paulo
 2013-03
NCT00760760 COMPLETED
Adipose Tissue Inflammation; Morbid Obesity
Medical University of Vienna
 2008-09 PHASE2
NCT02113163 COMPLETED
Diabetes Mellitus, Non-Insulin-Dependent; Hypertriglyceridemia
Thetis Pharmaceuticals LLC
 2014-03 PHASE1
NCT02113696 COMPLETED
Morbid Obesity
Pontificia Universidade Católica do Rio Grande do Sul
 2014-05
NCT01908374 UNKNOWN
Hypertriglyceridemia
Arctic Nutrition AS
 2013-07
NCT01274910 UNKNOWN
Rheumatoid Arthritis
Rabin Medical Center
 2011-01
NCT01940679 COMPLETED
Bioavailability of Omega-3s in Military Rations
United States Army Research Institute of Environmental Medicine
 2013-09
NCT02859129 COMPLETED
Hypertriglyceridemia
AstraZeneca
 2013-09 PHASE1
NCT01692431 COMPLETED
Cardiovascular Physiological Phenomena; Endothelial Nitric Oxide Synthase; Eicosapentaenoic Acid; Docosahexaenoic Acid (All-Z Isomer)
University of East Anglia
 2012-09
NCT01434381 COMPLETED
Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
 2011-08 PHASE1
NCT00485615 COMPLETED
Social Anxiety Disorder
START Clinic for Mood and Anxiety Disorders
 2008-10 PHASE2
NCT01614249 COMPLETED
Depressive Symptoms
University of Nairobi
 2012-06
NCT01965054 WITHDRAWN
Intrahepatic Cholestasis of Pregnancy
Icahn School of Medicine at Mount Sinai
 2012-12
NCT02036307 TERMINATED
Hypertriglyceridemia
Johns Hopkins University
 2013-04 PHASE2
NCT03258840 COMPLETED
Diabetes Mellitus Type II
Tehran University of Medical Sciences
 2013-01
NCT00983983 COMPLETED
Amyotrophic Lateral Sclerosis
Massachusetts General Hospital
 2009-10 PHASE2
NCT00361374 COMPLETED
Major Depressive Disorder
Massachusetts General Hospital
 2006-07 PHASE3
NCT01554462 COMPLETED
Attention Deficit Hyperactivity Disorder; Healthy
Unilever R&D
 2009-01
NCT01320319 UNKNOWN
Colorectal Cancer
University of Nottingham
 2011-03 PHASE2; PHASE3
NCT01480687 UNKNOWN
Hypertension; Hypertriglyceridemia
Hospital Universitario Pedro Ernesto
 2011-05 PHASE4
NCT01078909 COMPLETED
Cardiovascular Disease; Inflammation
Penn State University
 2011-10 PHASE3
NCT00345176 COMPLETED
Age-related Macular Degeneration; Cataract
National Eye Institute (NEI)
 2006-09 PHASE3
NCT01154985 COMPLETED
Steatohepatitis
Mochida Pharmaceutical Company, Ltd.
 2010-06 PHASE2
NCT01797757 COMPLETED
Obesity
Société des Produits Nestlé (SPN)
 2012-01
NCT00711971 COMPLETED
Depression
University of Michigan
 2008-09 PHASE2; PHASE3
NCT00891826 COMPLETED
Bipolar Disorders
Ludwig-Maximilians - University of Munich
 2009-04
NCT01241474 COMPLETED
Metabolic Syndrome X; Type 2 Diabetes Mellitus; Sarcopenia
University of Aberdeen
 2009-02
NCT01544855 COMPLETED
Healthy
Université de Sherbrooke
 2011-02
NCT01486433 COMPLETED
Hypertriglyceridemia
AstraZeneca
 2011-11 PHASE1
NCT01202812 UNKNOWN
Sickle Cell Disease; HEMOGLOBIN SS; Hemoglobin S Beta-0 Thalassemia; Inflammation; Quality of Life
Thomas Jefferson University
 2010-10 PHASE2
NCT01399216 COMPLETED
Low Basal Body Temperature
Hiroshima University
 2011-07
NCT01048463 UNKNOWN
Gastric Cancer; Colorectal Cancer; Chemotherapy
Sun Yat-sen University
 2009-12 PHASE3
NCT01138774 COMPLETED
Obesity; Body Fat; Insulin Resistance
Clinica Universidad de Navarra, Universidad de Navarra
 2010-01
NCT00323414 COMPLETED
Fatty Liver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2006-04 PHASE2
NCT01431690 COMPLETED
Hypertriglyceridemia
AstraZeneca
 2011-08 PHASE1
NCT00621829 COMPLETED
Asthma
University of California, Davis
 2008-02
NCT01070355 COMPLETED
Colorectal Cancer
University of Leeds
 2010-04 PHASE2
NCT01154400 COMPLETED
Chronic Obstructive Pulmonary Disease
Texas A&M University
 2009-05
NCT01308710 COMPLETED
Hyperlipidemia
University of California, San Francisco
 2010-01 PHASE1
NCT01400490 UNKNOWN
Heart Disease
Cardiovascular Research Associates
 2010-09
NCT01992809 COMPLETED
Fatty Liver
University of Sao Paulo General Hospital
 2009-09 PHASE3
NCT00871377 COMPLETED
Epilepsy
National Center for Complementary and Integrative Health (NCCIH)
 2008-05 PHASE2
NCT01749202 COMPLETED
Sudden Cardiac Death; Sudden Cardiac Arrest; Cardiovascular Disease
Solae, LLC
 2010-08
NCT01216982 UNKNOWN
Mood Disorders; Depression; Combat Disorders; Stress Disorders
United States Department of Defense
 2010-11 PHASE2
NCT01350999 COMPLETED
Hypertriglyceridemia
Takeda
 2009-11 PHASE3
NCT00517036 COMPLETED
Depression
Cedars-Sinai Medical Center
 2006-07 PHASE3
NCT01369550 COMPLETED
Healthy Volunteers; Markers of Cardiovascular Risk
Monsanto Company, LLC
 2010-08
NCT01350973 COMPLETED
Hypertriglyceridemia
Takeda
 2009-11 PHASE3
NCT01208961 COMPLETED
Severe Hypertriglyceridemia
AstraZeneca
 2010-09 PHASE2
NCT01092377 COMPLETED
Iron Deficiency; Anemia
North-West University, South Africa
 2010-02
NCT00598325 COMPLETED
Smoking
Nabi Biopharmaceuticals
 2008-01 PHASE1; PHASE2
NCT00790140 UNKNOWN
Esophageal Cancer
University of Dublin, Trinity College
 2005-07 PHASE4
NCT00692718 UNKNOWN
Acute Heart Failure; Acute Myocardial Infarction
Osaka General Medical Center
 2008-07 PHASE4
NCT01028274 COMPLETED
LDL Cholesterol; Triglycerides
Nordic Pharma, USA
 2009-09 PHASE1; PHASE2
NCT01048970 UNKNOWN
Lung Cancer
National Institute of Cancerología
 2009-10 PHASE2; PHASE3
NCT00487097 COMPLETED
Pressure Sores; Intensive Care
Rabin Medical Center
 2007-09
NCT01735357 COMPLETED
Healthy
King's College London
 2009-06
NCT00815685 COMPLETED
Cancer Cachexia
H. Lee Moffitt Cancer Center and Research Institute
 2007-07
NCT01038440 COMPLETED
Sudden Cardiac Death; Sudden Cardiac Arrest; Cardiovascular Disease
Solae, LLC
 2009-08
NCT00804427 COMPLETED
Hypertriglyceridemia
Stanford University
 2008-12
NCT00988585 COMPLETED
Heart Disease
Cardiovascular Research Associates
 2009-04 PHASE1
NCT00290056 UNKNOWN
Coronary Artery Disease; Arrhythmia
Sheba Medical Center
 2005-11 PHASE4
NCT00585390 COMPLETED
Schizophrenia; Fatty Acid Deficiency
University of Cincinnati
 2008-01 PHASE2; PHASE3
NCT00886704 COMPLETED
Atherosclerosis
Ludwig-Maximilians - University of Munich
 2009-04
NCT00634686 UNKNOWN
Osteoporosis; Frailty
Donaghue Medical Research Foundation
 2007-01 PHASE4
NCT00817622 COMPLETED
Diabetes Mellitus
Tehran University of Medical Sciences
 2007-01 PHASE4
NCT01061554 COMPLETED
Healthy
Ayanda AS
 2009-03 PHASE1
NCT02537236 COMPLETED
Human Immunodeficiency Virus
Instituto Mexicano del Seguro Social
 2009-01 PHASE3
NCT00455416 UNKNOWN
Follicular Lymphoma
Oslo University Hospital
 2007-04 PHASE2
NCT00351533 COMPLETED
Respiratory Distress Syndrome, Adult; Acute Lung Injury; Acute Respiratory Distress Syndrome
University of Washington
 2006-07 PHASE2
NCT00329680 COMPLETED
Sepsis; Severe Sepsis; Septic Shock
Fernandes Tavora Hospital
 2007-06 PHASE4
NCT01075919 COMPLETED
Cognitive Function; Mood
Northumbria University
 2007-12
NCT00839449 COMPLETED
Subarachnoid Hemorrhage; Cerebral Vasospasm
Yamaguchi University Hospital
 2004-12 PHASE4
NCT00432913 COMPLETED
Adenomatous Polyps
S.L.A. Pharma AG
 2006-10 PHASE2; PHASE3
NCT00014027 COMPLETED
Healthy
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2001-04-04 PHASE1
NCT00510692 COMPLETED
Familial Adenomatous Polyposis Coli; FAP
S.L.A. Pharma AG
 2006-11 PHASE2; PHASE3
NCT00398333 TERMINATED
Colorectal Neoplasms
Hospital Clinic of Barcelona
 2005-06 PHASE4
NCT00256412 COMPLETED
Major Depression
University of Iowa
 2005-10
NCT00146211 COMPLETED
Huntington Disease
Amarin Neuroscience Ltd
 2005-09 PHASE3
NCT00096798 COMPLETED
Depressive Disorder; Depression
National Center for Complementary and Integrative Health (NCCIH)
 2001-09 PHASE3
NCT00578578 TERMINATED
Coronary Artery Disease; Inflammatory Response; Atherosclerosis
The Cleveland Clinic
 2005-09 PHASE4
NCT00678067 COMPLETED
Hypercholesterolemia
University of Milan
 2005-06
NCT00402389 COMPLETED
Depression; Depression, Postpartum
University of Arizona
 2004-06 PHASE2
NCT01087710 COMPLETED
Asthma
Abbott Nutrition
 2004-07 PHASE2
NCT00634361 COMPLETED
Schizophrenia Prodrome
Yale University
 2001-09 PHASE2; PHASE3
NCT00312455 COMPLETED
Substance-related Disorders
National Institute on Drug Abuse (NIDA)
 2004-07 PHASE2
NCT00628017 COMPLETED
Alzheimer's Disease; Mild Cognitive Impairment
Taipei City Psychiatric Center, Taiwan
 2003-01
NCT00419146 COMPLETED
Schizophrenia; Schizophreniform Disorders; Schizoaffective Disorder; Psychotic Disorders
University Hospital, Aker
 2001-09 PHASE2; PHASE3
NCT00031707 COMPLETED
Anorexia; Cachexia
Alliance for Clinical Trials in Oncology
 2000-03 PHASE3
NCT01422317 COMPLETED
Coronary Disease; Myocardial Infarction
Helse Stavanger HF
 1995-09 PHASE3
NCT00231738 COMPLETED
Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease
Kobe University
 1996-11 PHASE4
NCT00001146 COMPLETED
Bipolar Disorder; Involutional Depression; Mood Disorder
National Institute of Mental Health (NIMH)
 1999-10 PHASE2
NCT00114595 COMPLETED
Dyskinesia; Schizophrenia
University of Stellenbosch
 2003-04 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-02-27)

Check the Eicosapentaenoic Acid (EPA) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an omega-3 polyunsaturated fatty acid, eicosapentaenoic acid incorporates into cellular membrane phospholipids and competitively inhibits cyclooxygenase and lipoxygenase enzymes, thereby suppressing the synthesis of pro-inflammatory arachidonic acid-derived eicosanoids. This enzyme inhibition attenuates downstream inflammatory signaling cascades and endothelial cell activation, ultimately mitigating lipid aggregation and vascular inflammation in clinical conditions such as cardiovascular disease and atherosclerosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.