OMEGA-3-ACID ETHYL ESTERS
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Also known as Doconexent (dha ethyl ester)DualtisIcosapent (epa ethyl ester)K-85K85LovazaNebbaroOmacorOmega-3 acid ethyl estersOmega-3 marine triglyceridesOmtrygPrestylonTAK-085Teromeg
Summary
Omega-3-Acid Ethyl Esters (CHEMBL1200711) is an approved small molecule (ATC C10AX06); indicated across 69 conditions including cardiovascular disorder and diabetes mellitus.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: C10AX06
- Indications: 69 conditions
- Clinical trials: 77
- Chemistry: 687 Da · C46H70O4
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1200711 |
| Name | OMEGA-3-ACID ETHYL ESTERS |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | no |
| PubChem CID | 9831414 |
| ATC | C10AX06 |
| Molecular formula | C46H70O4 |
| Molecular weight | 687 |
| InChIKey | DTMGIJFHGGCSLO-FIAQIACWSA-N |
SMILES: CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)OCC.CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCC(=O)OCC
IUPAC name: ethyl (4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoate;ethyl (5Z,8Z,11Z,14Z,17Z)-icosa-5,8,11,14,17-pentaenoate
Also known as: Doconexent (dha ethyl ester), Dualtis, Icosapent (epa ethyl ester), K-85, K85, Lovaza, Nebbaro, Omacor, Omega-3 acid ethyl esters, Omega-3 marine triglycerides, Omtryg, Prestylon
Patent coverage: 294 distinct patent families (696 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
69 indications (4 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| cardiovascular disorder | 4 | MONDO:0004995 | EFO:0000319 |
| diabetes mellitus | 4 | MONDO:0005015 | EFO:0000400 |
| hypothyroidism | 4 | MONDO:0005420 | EFO:0004705 |
| type 2 diabetes mellitus | 4 | MONDO:0005148 | MONDO:0005148 |
| hypertriglyceridemia | 3 | MONDO:0005347 | EFO:0004211 |
| atrial fibrillation | 3 | MONDO:0004981 | EFO:0000275 |
| myocardial infarction | 3 | MONDO:0005068 | EFO:0000612 |
| metabolic dysfunction-associated steatotic liver disease | 3 | MONDO:0013209 | EFO:0003095 |
| heart failure | 3 | MONDO:0005252 | EFO:0003144 |
| acne | 3 | MONDO:0011438 | EFO:0003894 |
| peripheral arterial disease | 3 | MONDO:0005386 | EFO:0004265 |
| familial hypercholesterolemia | 3 | MONDO:0005439 | EFO:0004911 |
| pyelonephritis | 3 | MONDO:0006939 | EFO:1001141 |
| intermittent vascular claudication | 3 | MONDO:0005295 | EFO:0003876 |
| attention deficit-hyperactivity disorder | 3 | MONDO:0007743 | EFO:0003888 |
| specific language impairment 5 | 3 | MONDO:0014184 | EFO:0005425 |
| dry eye syndrome | 3 | MONDO:0006733 | EFO:1000906 |
| myocardial ischemia | 3 | MONDO:0024644 | EFO:1001375 |
| HIV infectious disease | 3 | MONDO:0005109 | EFO:0000764 |
| hypertensive disorder | 3 | MONDO:0005044 | EFO:0000537 |
| heart disorder | 3 | MONDO:0005267 | EFO:0003777 |
| Alzheimer disease | 3 | MONDO:0004975 | MONDO:0004975 |
| metabolic disease | 3 | MONDO:0005066 | EFO:0000589 |
| endocrine system disorder | 3 | MONDO:0005151 | EFO:0001379 |
| vascular disorder | 3 | MONDO:0005385 | EFO:0004264 |
| myositis disease | 2 | MONDO:0021167 | EFO:0000783 |
| chronic kidney disease | 2 | MONDO:0005300 | EFO:0003884 |
| periodontitis | 2 | MONDO:0005076 | EFO:0000649 |
| epilepsy | 2 | MONDO:0005027 | EFO:0000474 |
| acute lymphoblastic leukemia | 2 | MONDO:0004967 | EFO:0000220 |
| autism spectrum disorder | 2 | MONDO:0005258 | EFO:0003756 |
| IgA glomerulonephritis | 2 | MONDO:0005342 | EFO:0004194 |
| psychotic disorder | 2 | MONDO:0005485 | EFO:0005407 |
| postpartum depression | 2 | MONDO:0005929 | EFO:0007453 |
| autism | 2 | MONDO:0005260 | EFO:0003758 |
| lichen planus, oral | 2 | MONDO:0043923 | EFO:0008517 |
| dysthymic disorder | 2 | MONDO:0001442 | EFO:0008623 |
| major depressive disorder | 2 | MONDO:0002009 | MONDO:0002009 |
| breast neoplasm | 2 | MONDO:0021100 | MONDO:0007254 |
| depressive disorder | 2 | MONDO:0002050 | MONDO:0002050 |
| stomatitis | 2 | MONDO:0004842 | EFO:1001904 |
| type 1 diabetes mellitus | 2 | MONDO:0005147 | MONDO:0005147 |
| bipolar disorder | 2 | MONDO:0004985 | MONDO:0004985 |
| injury | 1 | MONDO:0021178 | EFO:0000546 |
| head and neck squamous cell carcinoma | 1 | MONDO:0010150 | EFO:0000181 |
| melanoma | 1 | MONDO:0005105 | EFO:0000756 |
| exocrine pancreatic carcinoma | 1 | MONDO:0005192 | EFO:0002618 |
| non-small cell lung carcinoma | 1 | MONDO:0005233 | EFO:0003060 |
| cutaneous neuroendocrine carcinoma | 1 | MONDO:0019210 | EFO:1001471 |
| fatty liver disease | 1 | MONDO:0004790 | HP:0001397 |
| urothelial carcinoma | 1 | MONDO:0040679 | EFO:0008528 |
| non-Hodgkin lymphoma | 1 | MONDO:0018908 | EFO:0005952 |
| breast carcinoma in situ | 1 | MONDO:0004658 | MONDO:0004658 |
| ovarian cancer | 1 | MONDO:0008170 | MONDO:0008170 |
| severe acute respiratory syndrome | 1 | MONDO:0005091 | MONDO:0100096 |
| colorectal neoplasm | 1 | MONDO:0005335 | MONDO:0005575 |
| Chagas cardiomyopathy | 0 | MONDO:0005491 | EFO:0005529 |
| metabolic syndrome X | 0 | MONDO:0011565 | EFO:0000195 |
11 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 77.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE4 | 21 |
| PHASE1/PHASE2 | 14 |
| Not specified | 13 |
| PHASE3 | 11 |
| PHASE2 | 8 |
| PHASE1 | 4 |
| PHASE2/PHASE3 | 3 |
| EARLY_PHASE1 | 3 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00246636 | PHASE4 | COMPLETED | 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 |
| NCT00257283 | PHASE4 | COMPLETED | Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis |
| NCT00286234 | PHASE4 | COMPLETED | Niacin, N-3 Fatty Acids and Insulin Resistance |
| NCT00296153 | PHASE4 | COMPLETED | Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment |
| NCT00328536 | PHASE4 | COMPLETED | Omacor for the Treatment of Vascular Dysfunction in Patients With Type 2 Diabetes Mellitus |
| NCT00598910 | PHASE4 | TERMINATED | Effect of Omacor on Triglycerides in HIV Infected Subjects |
| NCT00678743 | PHASE4 | COMPLETED | An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin |
| NCT00760513 | PHASE4 | COMPLETED | Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids |
| NCT00791089 | PHASE4 | TERMINATED | Effects of Fish Oil on Post Ablation Arrhythmias |
| NCT00795717 | PHASE4 | COMPLETED | Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial |
| NCT00833976 | PHASE4 | COMPLETED | Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia |
| NCT00891293 | PHASE4 | COMPLETED | 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™ |
| NCT00934219 | PHASE4 | UNKNOWN | Triglyceride Lowering Study |
| NCT00941642 | PHASE4 | UNKNOWN | Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease |
| NCT01010399 | PHASE4 | COMPLETED | Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects |
| NCT01041521 | PHASE4 | COMPLETED | The Impact of Omega Three Fatty Acids on Vascular Function in HIV |
| NCT01046604 | PHASE4 | UNKNOWN | Pilot Study of Lovaza (Omega 3 Fatty Acids) to Improve Cardiac Antioxidant/Anti-inflammatory Profile Before Cardiac Surgery |
| NCT01180764 | PHASE4 | WITHDRAWN | Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia |
| NCT02010359 | PHASE4 | COMPLETED | Fish Oils and Adipose Inflammation Reduction |
| NCT02824432 | PHASE4 | COMPLETED | Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation |
| NCT02839902 | PHASE4 | COMPLETED | Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood |
| NCT00149409 | PHASE2/PHASE3 | COMPLETED | Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure |
| NCT00246701 | PHASE3 | COMPLETED | Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects |
| NCT00294216 | PHASE3 | COMPLETED | Omacor and Placebo in Carotid Plaque Stability |
| NCT00402363 | PHASE3 | COMPLETED | Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation |
| NCT00435045 | PHASE3 | COMPLETED | Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia |
| NCT00915902 | PHASE2/PHASE3 | COMPLETED | Fish Oil Study for High Triglyceride Levels in Children |
| NCT00944229 | PHASE3 | TERMINATED | The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure |
| NCT01277237 | PHASE3 | COMPLETED | The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease |
| NCT01350973 | PHASE3 | COMPLETED | Efficacy of TAK-085 in Participants With Hypertriglyceridemia |
| NCT01350999 | PHASE3 | COMPLETED | Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia |
| NCT01367145 | PHASE3 | COMPLETED | OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease |
| NCT02625870 | PHASE3 | UNKNOWN | Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides |
| NCT03018041 | PHASE3 | COMPLETED | The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation |
| NCT05281562 | PHASE2/PHASE3 | TERMINATED | Immunonutrition for Diabetic Foot Ulcers |
| NCT06195306 | PHASE2 | RECRUITING | Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction |
| NCT00515541 | PHASE2 | COMPLETED | Lovaza’s Effect on the Activation of Platelets |
| NCT00517972 | PHASE2 | WITHDRAWN | Omacor for Perimenopausal Depression |
| NCT00672633 | PHASE2 | TERMINATED | Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides |
| NCT00771914 | PHASE1/PHASE2 | COMPLETED | The Effects of Omega-3 Fatty Acids on Aspirin Resistance |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Diseases: cardiovascular disorder, diabetes mellitus, hypothyroidism, type 2 diabetes mellitus, hypertriglyceridemia, atrial fibrillation, myocardial infarction, metabolic dysfunction-associated steatotic liver disease, heart failure, acne, peripheral arterial disease, familial hypercholesterolemia, pyelonephritis, intermittent vascular claudication, attention deficit-hyperactivity disorder, specific language impairment 5, dry eye syndrome, myocardial ischemia, HIV infectious disease, hypertensive disorder, heart disorder, Alzheimer disease, metabolic disease, endocrine system disorder, vascular disorder