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AMR101
AMR101 is a high-purity eicosapentaenoic acid (EPA) that reduces triglycerides by inhibiting hepatic triglyceride synthesis and enhancing fatty acid oxidation.
AMR101 is a high-purity eicosapentaenoic acid (EPA) that reduces triglycerides by inhibiting hepatic triglyceride synthesis and enhancing fatty acid oxidation. Used for Hypertriglyceridemia in patients on statin therapy with elevated triglycerides.
At a glance
| Generic name | AMR101 |
|---|---|
| Also known as | VASCEPA, VASCEPA® (icosapent ethyl) |
| Sponsor | Massachusetts General Hospital |
| Drug class | Omega-3 fatty acid |
| Target | Hepatic triglyceride synthesis pathway |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
AMR101 (icosapent ethyl) is a prescription-strength omega-3 fatty acid that selectively increases EPA levels in the blood. It works by reducing the production of triglycerides in the liver and promoting their clearance, thereby lowering circulating triglyceride levels in patients with elevated triglyceridemia, particularly those on statin therapy.
Approved indications
- Hypertriglyceridemia in patients on statin therapy with elevated triglycerides
Common side effects
- Bleeding
- Atrial fibrillation
- Musculoskeletal pain
- Gout
Key clinical trials
- IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion (PHASE2)
- Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body (PHASE1, PHASE2)
- The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism (NA)
- EPA for Metastasis Trial 2 (PHASE3)
- Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) (PHASE4)
- CreNeuroS™️CNS Fish Oil Plus Softgels Compared to Vascepa® Capsules and Deplin® Capsules in a Pharmacokinetic, Single Dose Evaluation on Healthy Adult Human Subjects Under Fasting Conditions (NA)
- Effect of Icosapent-ethyl Ester (IPE) to Reduce the Residual Risk Cardiovascular Disease. (NA)
- Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia (PHASE3)
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:
- AMR101 CI brief — competitive landscape report
- AMR101 updates RSS · CI watch RSS
- Massachusetts General Hospital portfolio CI