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Vascepa (ICOSAPENT ETHYL)
Vascepa (icosapent ethyl) is a small molecule modality developed by Amarin Pharmaceuticals, targeting Diacylglycerol O-acyltransferase 1. It is an FDA-approved medication for treating hyperlipidemia and hypertriglyceridemia, with a half-life of 89 hours. Vascepa is currently owned by Amarin Pharmaceuticals and has 11 generic manufacturers. The commercial status of Vascepa is not explicitly stated, but it is likely to be off-patent given its 2012 FDA approval. Key safety considerations include its potential effects on cardiovascular health.
At a glance
| Generic name | ICOSAPENT ETHYL |
|---|---|
| Sponsor | Amarin Pharms |
| Drug class | icosapent ethyl |
| Target | Diacylglycerol O-acyltransferase 1 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2012 |
Approved indications
- Hyperlipidemia
- Hypertriglyceridemia
Common side effects
- Atrial Fibrillation
- Musculoskeletal pain
- Peripheral edema
- Constipation
- Gout
- Arthralgia
- Oropharyngeal pain
- Diarrhea
- Blood triglycerides increased
- Abdominal discomfort
- Pain in the extremities
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vascepa CI brief — competitive landscape report
- Vascepa updates RSS · CI watch RSS
- Amarin Pharms portfolio CI