VASCEPA (icosapent ethyl)
Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adults with elevated triglyceride levels (≥150 mg/dL) and either established cardiovascular disease or diabetes mellitus plus two or more additional cardiovascular risk factors. It is also indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
How VASCEPA Works
Icosapent ethyl is a purified ethyl ester of the omega-3 fatty acid EPA. It reduces hepatic very low-density lipoprotein triglyceride (VLDL-TG) synthesis and secretion while enhancing TG clearance from circulating VLDL particles. Specific mechanisms include increased β-oxidation, inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT), decreased hepatic lipogenesis, and increased plasma lipoprotein lipase activity. The mechanism for cardiovascular event reduction is likely multifactorial, involving an increased EPA/arachidonic acid ratio and improved EPA lipid composition in carotid plaques; it may also involve the inhibition of platelet aggregation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-07-26
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- CAPSULE
VASCEPA Approval History
What VASCEPA Treats
4 indicationsVASCEPA is approved for 4 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cardiovascular Disease
- Diabetes
- Hypertriglyceridemia
- Unstable Angina
VASCEPA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in VASCEPA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VASCEPA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to VASCEPA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06466278 SALVAGE | NL81780.018.22 | Ph 2 | active not recruiting | IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion |
| NCT03428477 EMT2 | MO16/053 | Ph 3 | active not recruiting | EPA for Metastasis Trial 2 |
| NCT06280976 ARTCAP | 23.0001 | Ph 4 | withdrawn | Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) |
| NCT04505098 MITIGATE | 1597940 | Ph 4 | terminated | A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults |
| NCT02926027 EVAPORATE results posted | 21733-01 | Ph 4 | completed | Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy |
| NCT02422446 results posted | 2013D003968 | Ph 3 | terminated | Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects |
| NCT04177680 ENHANCE-IT results posted | MAT-002 | Ph 2 | completed | Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia |
| NCT04412018 | Pro00043601 | Ph 2 | completed | An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VASCEPA FDA Label Details
Indications & Usage
FDA Label (PDF)VASCEPA is indicated for the treatment of Cardiovascular Disease; Diabetes; Hypertriglyceridemia; Unstable Angina.
VASCEPA Patents & Exclusivity
Patents (63 active)
Pro Intelligence Preview
Deep insights for VASCEPA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 256 active patents
Trial Analysis
- • 8 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment