Investigational Drug Details
| Drug ID: | D257 |
| Drug Name: | OMACOR |
| Synonyms: | Omega-3 fatty acid ethyl esters; Omega-3-acid ethyl esters |
| Type: | Chemical drug |
| DrugBank ID: | DB09539 |
| DrugBank Description: | Omega-3-acid ethyl esters are prescription drugs that contain eicosapentaenoic acid-ethyl ester (EPA) and docosahexaenoic acid-ethyl ester (DHA) that are used in combination with changes in diet to lower triglyceride levels in adults with severe (≥ 500 mg/dL) hypertriglyceridemia. Omega-3-acid ethyl esters are currently marketed in the US, EU, and many other regions under the brand name Lovaza. |
| PubChem ID: | 9831414 |
| CasNo: | 861006-80-6 |
| Repositioning for NAFLD: | Yes |
| SMILES: | C(=C\C/C=C\C/C=C\C/C=C\C/C=C\CC)\CCCC(=O)OCC.C(=C\C/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CC)\CCC(=O)OCC |
| Structure: |
|
| InChiKey: | DTMGIJFHGGCSLO-FIAQIACWSA-N |
| Molecular Weight: | 687.062 |
| DrugBank Targets: | Sterol regulatory element-binding protein 1 inhibitor |
| DrugBank MoA: | Omega-3-acid ethyl esters reduce triglyceride production by the liver but this mechanism is not well understood. Omega-3-acid ethyl esters inhibit acyl-CoA:1,2-diacylglycerol acyltransferase, reducing triglyceride synthesis and increasing paroxysmal beta-oxidation, which increases fatty aside metabolism. Omega-3-acid ethyl esters also inhibit the release of fatty acids by competing for enzymes involved in the synthesis of triglycerides, increase triglyceride clearance by increasing the activity of lipoprotein lipase, and decrease production of VLDL-C. |
| DrugBank Pharmacology: | Omega-3-acid ethyl esters reduce triglyceride production, increase fatty acid metabolism, inhibit the release of fatty acids, increase triglyceride clearance, and decrease production of very low density lipoprotein cholesterol(VLDL-C). |
| DrugBank Indication: | Omega-3-Acid Ethyl Esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG). |
| Targets: | -- |
| Therapeutic Category: | Hypolipidemic drug |
| Clinical Trial Progress: | Phase 3 completed (NCT01277237) |
| Latest Progress: | Under clinical trials |
| Trial ID | Source ID | Phases | Status | Study Results | Start Date | Last Update Posted | |
|---|---|---|---|---|---|---|---|
| L0001 | NCT01277237 | Phase 3 | Completed | No Results Available | September 2010 | January 23, 2014 | Details |
| L0020 | NCT00760513 | Phase 4 | Completed | Has Results | November 1, 2009 | October 25, 2019 | Details |
| L0967 | EUCTR2008-008275-34-GB | Phase 3 | Not Recruiting | No Results Available | 06/07/2009 | 25 November 2019 | Details |
| Target ID | Target Name | GENE | Action | Class | UniProtKB ID | Entry Name |
|---|
| Strategy ID | Strategy | Synonyms | Related Targets | Related Drugs |
|---|
| Article ID | PMID | Source | Title | |
|---|---|---|---|---|
| A14070 | 29603349 | J Leukoc Biol | Leukocyte extracellular vesicle concentration is inversely associated with liver fibrosis severity in NAFLD. | Details |
| A16593 | 28294174 | Eur J Clin Nutr | Docosahexaenoic acid enrichment in NAFLD is associated with improvements in hepatic metabolism and hepatic insulin sensitivity: a pilot study. | Details |
| A18472 | 27106721 | Diabetologia | Higher body fat percentage is associated with enhanced temperature perception in NAFLD: results from the randomised Wessex Evaluation of fatty Liver and Cardiovascular markers in NAFLD with OMacor thErapy trial (WELCOME) trial. | Details |
| A19121 | 26748347 | Atherosclerosis | Improvement in non-alcoholic fatty liver disease severity is associated with a reduction in carotid intima-media thickness progression. | Details |
| A19911 | 26272871 | J Hepatol | Treating liver fat and serum triglyceride levels in NAFLD, effects of PNPLA3 and TM6SF2 genotypes: Results from the WELCOME trial. | Details |
| A20341 | 26021488 | Diabetologia | Impact of high dose n-3 polyunsaturated fatty acid treatment on measures of microvascular function and vibration perception in non-alcoholic fatty liver disease: results from the randomised WELCOME trial. | Details |
| A21791 | 25043514 | Hepatology | Effects of purified eicosapentaenoic and docosahexaenoic acids in nonalcoholic fatty liver disease: results from the Welcome* study. | Details |
| A22455 | 24556343 | Contemp Clin Trials | Design and rationale of the WELCOME trial: A randomised, placebo controlled study to test the efficacy of purified long chainomega-3 fatty acid treatment in non-alcoholic fatty liver disease [corrected]. | Details |