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Omacor®
Omacor is a prescription omega-3 fatty acid formulation that reduces triglyceride levels by decreasing hepatic triglyceride synthesis and increasing fatty acid oxidation.
Omacor is a prescription omega-3 fatty acid formulation that reduces triglyceride levels by decreasing hepatic triglyceride synthesis and increasing fatty acid oxidation. Used for Hypertriglyceridemia (elevated triglycerides) as adjunctive therapy to diet, Secondary prevention in patients with coronary artery disease.
At a glance
| Generic name | Omacor® |
|---|---|
| Also known as | Lovaza, Omega-3, N-3 Fatty acids, Omega-3 fatty acids, EPA |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Drug class | Omega-3 fatty acid |
| Target | Hepatic triglyceride synthesis pathway |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Omacor contains ethyl esters of omega-3 polyunsaturated fatty acids (EPA and DHA) derived from fish oil. These fatty acids work by inhibiting acyl-CoA synthetase and reducing the availability of precursors for triglyceride synthesis in the liver, while also promoting fatty acid oxidation. This results in significant reductions in plasma triglyceride concentrations, particularly in patients with hypertriglyceridemia.
Approved indications
- Hypertriglyceridemia (elevated triglycerides) as adjunctive therapy to diet
- Secondary prevention in patients with coronary artery disease
Common side effects
- Gastrointestinal upset (nausea, dyspepsia, diarrhea)
- Fishy aftertaste or odor
- Increased bleeding tendency
- Headache
Key clinical trials
- Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers (PHASE2)
- Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers (NA)
- QUILT-3.051: NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy (PHASE1, PHASE2)
- Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes (NA)
- Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL) (PHASE3)
- Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL (PHASE3)
- A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (PHASE3)
- Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Omacor® CI brief — competitive landscape report
- Omacor® updates RSS · CI watch RSS
- Hospital Universitari Vall d'Hebron Research Institute portfolio CI