ICOSAPENT ETHYL
ICOSAPENT ETHYL is indicated for the treatment of Hypertriglyceridemia.
Details
- Status
- Prescription
- First Approved
- 2020-05-21
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
ICOSAPENT ETHYL Approval History
What ICOSAPENT ETHYL Treats
1 indicationsICOSAPENT ETHYL is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertriglyceridemia
ICOSAPENT ETHYL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
Drugs Similar to ICOSAPENT ETHYL
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 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 |
| NCT04505098 MITIGATE | 1597940 | Ph 4 | terminated | A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults |
| 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.
ICOSAPENT ETHYL FDA Label Details
Indications & Usage
ICOSAPENT ETHYL is indicated for the treatment of Hypertriglyceridemia.
Looking for the branded version?
VASCEPA
Full clinical data, patents, trials, and competitive landscape for icosapent ethyl.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.