OMEGA-3-ACID ETHYL ESTERS
Omega-3-acid ethyl esters are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL). Clinical management should first include a specialized lipid-lowering diet, exercise, and weight loss, as well as the management of contributing factors such as diabetes, hypothyroidism, or medications known to exacerbate hypertriglyceridemia (e.g., beta-blockers, thiazides, estrogens). **Limitations of Use:** The effect of this medication on the risk of pancreatitis and its impact on cardiovascular mortality and morbidity have not been determined.
How OMEGA-3-ACID ETHYL ESTERS Works
The exact mechanism of action is not completely understood but involves several hepatic pathways to reduce triglyceride synthesis. Key mechanisms include the inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal β-oxidation, and decreased hepatic lipogenesis. Additionally, EPA and DHA serve as poor substrates for the enzymes responsible for triglyceride synthesis and inhibit the esterification of other fatty acids, while potentially increasing plasma lipoprotein lipase (LPL) activity. These combined effects result in a reduction of VLDL-TG secretion into the blood.
Details
- Status
- Discontinued
- First Approved
- 2014-04-07
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
OMEGA-3-ACID ETHYL ESTERS Approval History
What OMEGA-3-ACID ETHYL ESTERS Treats
1 indicationsOMEGA-3-ACID ETHYL ESTERS is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Severe hypertriglyceridemia
OMEGA-3-ACID ETHYL ESTERS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06195306 | NCI-2023-10830 NCI-2023-10830, UMICC 2024.076 | Ph 2 | recruiting | Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction |
| NCT03167164 | QUILT-3.045 | Ph 1, Ph 2 | withdrawn | QUILT-3.045: NANT Merkel Cell Carcinoma (MCC) Vaccine: Combination Immunotherapy in Subjects With MCC Who Have Progressed on or After PD-L1 Therapy |
| NCT03167177 | QUILT-3.046 | Ph 1, Ph 2 | withdrawn | QUILT-3.046: NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed On or After Chemotherapy and PD-1/PD-L1 Therapy |
| NCT00915902 results posted | GIDDING | Ph 2, Ph 3 | completed | Fish Oil Study for High Triglyceride Levels in Children |
| NCT00694746 | IIT40 | Ph 1 | terminated | Study of Fish Oil to Reduce ALT Levels in Adolescents |
| NCT01431690 | OM-EPA-006 | Ph 1 | completed | Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of the Effects of Epanova and Lovaza on Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) After Low-fat Meals |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OMEGA-3-ACID ETHYL ESTERS FDA Label Details
Indications & Usage
OMEGA-3-ACID ETHYL ESTERS is indicated for the treatment of Severe hypertriglyceridemia.
Looking for the branded version?
LOVAZA
Full clinical data, patents, trials, and competitive landscape for omega-3-acid ethyl esters.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.