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EPA / DHA / Alpha-Tocopherol
A combination of omega-3 fatty acids (EPA and DHA) and vitamin E that reduces inflammation and oxidative stress to support cardiovascular and metabolic health.
A combination of omega-3 fatty acids (EPA and DHA) and vitamin E that reduces inflammation and oxidative stress to support cardiovascular and metabolic health. Used for Cardiovascular disease prevention or management (Phase 3 indication under investigation).
At a glance
| Generic name | EPA / DHA / Alpha-Tocopherol |
|---|---|
| Also known as | Omacor-R |
| Sponsor | Helse Stavanger HF |
| Drug class | Nutritional supplement / Omega-3 fatty acid combination |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) are long-chain omega-3 polyunsaturated fatty acids that modulate inflammatory pathways, reduce triglycerides, and improve endothelial function. Alpha-tocopherol (vitamin E) acts as an antioxidant to reduce oxidative stress. Together, these components work synergistically to improve lipid profiles and reduce cardiovascular risk.
Approved indications
- Cardiovascular disease prevention or management (Phase 3 indication under investigation)
Common side effects
- Gastrointestinal upset
- Fishy aftertaste
- Bleeding or bruising (at high doses)
Key clinical trials
- Study of the Efficacy and Safety of EPA in Patients With Type-2 Diabetes (PHASE4)
- Impact of Omega 3 in Alcohol Use Disorder (NA)
- Effects of a High EPA Multinutrient Supplement on Negative Affect in Young Adults. (NA)
- Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer (NA)
- Diabetic Retinopathy Functional Evaluation Study: Monitoring Carotenoid Vitamins Treatment Using ERG (NA)
- NAPLS Omega-3 Fatty Acid Versus Placebo Study (PHASE1)
- Intervention Study to Prevent Obesity in Sedentary 8 Year Old Swedish Children (NA)
- The Chronic Obstructive Pulmonary Disease Fish Oil Pilot Trial (NA)
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:
- EPA / DHA / Alpha-Tocopherol CI brief — competitive landscape report
- EPA / DHA / Alpha-Tocopherol updates RSS · CI watch RSS
- Helse Stavanger HF portfolio CI