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Omega-3-acid ethyl esters 90
Omega-3-acid ethyl esters reduce triglyceride levels by decreasing hepatic production of triglyceride-rich lipoproteins and increasing clearance of triglycerides from the bloodstream.
Omega-3-acid ethyl esters reduce triglyceride levels by decreasing hepatic production of triglyceride-rich lipoproteins and increasing clearance of triglycerides from the bloodstream. Used for Hypertriglyceridemia (severe, typically ≥500 mg/dL), Cardiovascular risk reduction in patients with elevated triglycerides.
At a glance
| Generic name | Omega-3-acid ethyl esters 90 |
|---|---|
| Also known as | Omacor versus placebo |
| Sponsor | Pronova BioPharma |
| Drug class | Fibrate-like lipid-lowering agent / Omega-3 fatty acid |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
This drug is a highly purified ethyl ester formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), omega-3 polyunsaturated fatty acids. It works by inhibiting hepatic synthesis of triglycerides and VLDL, while also enhancing the clearance of triglyceride-rich particles. The mechanism reduces circulating triglyceride concentrations, which is beneficial in managing hypertriglyceridemia and reducing cardiovascular risk.
Approved indications
- Hypertriglyceridemia (severe, typically ≥500 mg/dL)
- Cardiovascular risk reduction in patients with elevated triglycerides
Common side effects
- Eructation (fish-flavored burping)
- Dyspepsia
- Nausea
- Bleeding (minor, increased bleeding tendency)
Key clinical trials
- Effect of Omega 3 in Hypertensive Patients (NA)
- Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel (NA)
- Efficacy of Omega-3 as Adjunctive Therapy for Medically Intractable Epilepsy: A Prospective Open-label Pilot Study (PHASE2)
- Efficacy of TAK-085 in Participants With Hypertriglyceridemia (PHASE3)
- Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia (PHASE3)
- Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides (PHASE3)
- Effect of Omega-3 Fatty Acid on Vitamin D Activation (PHASE4)
- Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia (PHASE4)
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:
- Omega-3-acid ethyl esters 90 CI brief — competitive landscape report
- Omega-3-acid ethyl esters 90 updates RSS · CI watch RSS
- Pronova BioPharma portfolio CI