icosapent ethyl
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Vazkepa | — | 2021-03-26 | europa.eu ↗ |
| Label expansion | US (FDA) | VASCEPA | — | 2019-12-13 | fda.gov ↗ |
| Approved | US (FDA) | VASCEPA | — | 2012-07-26 | fda.gov ↗ |
Trials 21 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02113163 Comparator | Mar → Jun 2014 | hypertriglyceridemia, type 2 diabetes mellitus | Thetis Pharmaceuticals LLC | Completed | No outcome recorded |
| Phase 1 | NCT02859129 Comparator | Sep → Nov 2013 | hypertriglyceridemia | AstraZeneca | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04177680 Comparator | Jun → Nov 2020 | hypertriglyceridemia | Matinas BioPharma Nanotechnologies, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03661047 Comparator | Nov 2019 → Nov 2021 | colon carcinoma | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07680829 Background | Aug 2026 → Jun 2030 expected | — | Zhejiang Doer Biologics Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04460651 Comparator | Aug 2020 → Aug 2021 | COVID-19 | Estudios Clínicos Latino América | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04505098 Comparator | Aug 2020 → Dec 2022 | COVID-19, atherosclerosis, respiratory tract infectious disorder | Kaiser Permanente | Terminated | No outcome recorded |
| Phase 4 | NCT02926027 Comparator | Mar 2017 → May 2020 | hypertriglyceridemia | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-03-01 | CSL Behring | CSL Seqirus and Amarin sign licensing agreement to commercialise Vazkepa (icosapent ethyl) in Australia and New Zealand csl.com ↗ |
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | icosapent ethyl | “AMR101 (icosapent ethyl \[ethyl-EPA\]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular...” NCT01492361 ↗18“We evaluated the safety and efficacy of icosapent ethyl (Vascepa) and fenofibrate to mitigate triglyceride elevations in patients with NASH treated with CILO and FIR.” PMID 34999207 ↗ Jan 2022 “Icosapent ethyl is an omega-3 fatty acid and in a class of medications called antilipemic or lipid-regulating agents.” NCT05198843 ↗ “Icosapent ethyl (IPE; formerly AMR101) is a high-purity prescription form of eicosapentaenoic acid ethyl ester.” PMID 23312052 ↗ Jul 2012 “AMR101 is commercially available in the US as VASCEPA (icosapent ethyl).” NCT03661047 ↗ “AMR101 is commercially available in the US as VASCEPA (icosapent ethyl)” NCT04216251 ↗ “icosapent ethyl or Vascepa” NCT02113163 ↗ |
| Known as | AMR101 | “Icosapent ethyl (IPE; formerly AMR101) is a high-purity prescription form of eicosapentaenoic acid ethyl ester.” PMID 23312052 ↗ Jul 2012 |
| Known as | Eicosapentaenoic acid ethyl ester | “Each capsule contains: 460 mg eicosapentaenoic acid ethyl ester and 380 mg docosahexaenoic acid ethyl ester.” NCT02708771 ↗ |
| Known as | EPA-E | “This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).” NCT01154985 ↗ |
| Known as | Epadel | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095209 ↗ |
| Known as | EPADEL Capsule 300 TM | “Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM)” NCT00231738 ↗ |
| Known as | EPADEL S900 TM (EPA ethyl ester, purity >98%) | “EPADEL S900 TM (EPA ethyl ester, purity >98%)” NCT00839449 ↗ |
| Known as | Ethyl icosapent | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095209 ↗ |
| Known as | ethyl icosapentate | “This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).” NCT01154985 ↗ |
| Known as | ethyl-EPA | “AMR101 (icosapent ethyl \[ethyl-EPA\]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular...” NCT01492361 ↗ |
| Known as | Icosapent ethyl ester | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095209 ↗ |
| Known as | IPE | “The EPA for Metastasis Trial 2 trial is a randomised, double-blind, placebo-controlled, phase 3 trial of 4 g EPA ethyl ester (icosapent ethyl (IPE; Vascepa)) daily in patients...” PMID 38030258 ↗ Nov 20234“Icosapent ethyl (IPE; formerly AMR101) is a high-purity prescription form of eicosapentaenoic acid ethyl ester.” PMID 23312052 ↗ Jul 2012 “Icosapent ethyl (IPE), an omega-3 fatty acid, demonstrates both pro-resolving and cardioprotective properties.” PMID 41781043 ↗ Mar 2026 “purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE)” NCT02719327 ↗ “Icosapent ethyl (IPE) is a safe, well-tolerated oral therapy” NCT04460651 ↗ |
| Known as | MND-21 | “MND-21, a highly purified form of ethyl icosapentate” PMID 41500861 ↗ Dec 2025 |
| Known as | NSC-759597 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095209 ↗ |
| Known as | Timnodonic acid ethyl ester | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095209 ↗ |
| Known as | Vascepa | “We evaluated the safety and efficacy of icosapent ethyl (Vascepa) and fenofibrate to mitigate triglyceride elevations in patients with NASH treated with CILO and FIR.” PMID 34999207 ↗ Jan 20229“pre-treatment with icosapent ethyl (IPE), also known as Vascepa®, compared to usual standard of care” NCT04505098 ↗ “AMR101 is commercially available in the US as VASCEPA (icosapent ethyl).” NCT03661047 ↗ “Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]” NCT06710080 ↗ “Icosapent Ethyl 1000 MG [Vascepa]” NCT03885661 ↗ “icosapent ethyl or Vascepa” NCT02113163 ↗ “Vascepa” NCT04412018 ↗ |
| Known as | VASCEPA (icosapent ethyl) | “VASCEPA® (icosapent ethyl)” NCT01047683 ↗ |
| Known as | Vazkepa | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095209 ↗ |
| Modality | Small molecule | “Ethyl-eicosapentanoic acid (EPA-E) is a synthetic polyunsaturated fatty acid that reduces hypertriglyceridemia.” PMID 24818764 ↗ May 2014 |
| Route | Oral | “Patients in the group A are orally administered eicosapentaenoic acid ethyl ester.” NCT00839449 ↗ |