Last reviewed · How we verify
Icosapent ethyl (IPE)
Icosapent ethyl (IPE) is a Omega-3 fatty acid Small molecule drug developed by Estudios Clínicos Latino América. It is currently in Phase 3 development for Hypertriglyceridemia in patients on statin therapy, Cardiovascular risk reduction in patients with elevated triglycerides. Also known as: Vascepa®, Vascepa.
Icosapent ethyl is a purified ethyl ester of eicosapentaenoic acid (EPA) that reduces triglyceride levels and modulates lipid metabolism.
Icosapent ethyl is a purified ethyl ester of eicosapentaenoic acid (EPA) that reduces triglyceride levels and modulates lipid metabolism. Used for Hypertriglyceridemia in patients on statin therapy, Cardiovascular risk reduction in patients with elevated triglycerides.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Icosapent ethyl (IPE) |
|---|---|
| Also known as | Vascepa®, Vascepa |
| Sponsor | Estudios Clínicos Latino América |
| Drug class | Omega-3 fatty acid |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
IPE is an omega-3 fatty acid that acts as a substrate for lipid-lowering pathways, reducing hepatic triglyceride synthesis and increasing triglyceride clearance. It also has anti-inflammatory properties through modulation of eicosanoid production and may reduce cardiovascular risk through multiple mechanisms including effects on blood viscosity and endothelial function.
Approved indications
- Hypertriglyceridemia in patients on statin therapy
- Cardiovascular risk reduction in patients with elevated triglycerides
Common side effects
- Bleeding
- Atrial fibrillation
- Musculoskeletal pain
- Gout
Key clinical trials
- Effect of Icosapent-ethyl Ester (IPE) to Reduce the Residual Risk Cardiovascular Disease. (NA)
- Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid (PHASE2, PHASE3)
- The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk (PHASE4)
- PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial (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:
- Icosapent ethyl (IPE) CI brief — competitive landscape report
- Icosapent ethyl (IPE) updates RSS · CI watch RSS
- Estudios Clínicos Latino América portfolio CI
Frequently asked questions about Icosapent ethyl (IPE)
What is Icosapent ethyl (IPE)?
How does Icosapent ethyl (IPE) work?
What is Icosapent ethyl (IPE) used for?
Who makes Icosapent ethyl (IPE)?
Is Icosapent ethyl (IPE) also known as anything else?
What drug class is Icosapent ethyl (IPE) in?
What development phase is Icosapent ethyl (IPE) in?
What are the side effects of Icosapent ethyl (IPE)?
Related
- Drug class: All Omega-3 fatty acid drugs
- Manufacturer: Estudios Clínicos Latino América — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertriglyceridemia in patients on statin therapy
- Indication: Drugs for Cardiovascular risk reduction in patients with elevated triglycerides
- Also known as: Vascepa®, Vascepa
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing