Drugs / icosapent ethyl
icosapent ethyl
also known as
Vascepa · AMR101 · IPE · ethyl icosapentate · eicosapentaenoic acid ethyl ester · EPA-E · Epadel · EPADEL Capsule 300 TM · +9 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hypertriglyceridemia 2 1 milestone | |||||
| Filed | China (NMPA) | エパデールS | hypertriglyceridemia 2 | 2024-07-02 | “「エパデールS」（開発コード：MND-21、 以下 「本剤」 ）について、中国国家薬品監督管理局 （NMPA） に新薬承認申請を行いました” mochida.co.jp ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 missed | ||||||
| Phase 1 | NCT03885661 | Jan 2016 → Aug 2018 | hyperlipidemia, hypertriglyceridemia, lip disorder | University of Pennsylvania | Completed | Missed primary |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05198843 | Nov 2022 → Dec 2023 | female breast carcinoma, inflammatory breast carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04216251 | Dec 2020 → Sep 2022 | colorectal adenoma, colorectal cancer | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 25 trials · 1 missed | ||||||
| Phase 2 | NCT06466278 | Jun 2023 → Jul 2026 overdue | aortic valve stenosis | Academic Medical Center - University of Amsterdam | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04412018 | Jun → Nov 2020 | COVID-19, inflammatory disease | Canadian Medical and Surgical Knowledge Translation Research Group | Completed | No outcome recorded |
| Phase 2 | NCT02940223 | Mar 2017 → Nov 2020 | metastatic malignant neoplasm | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT02781584 | Jun 2016 → Dec 2020 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01154985 | Jun 2010 → Oct 2012 | metabolic dysfunction-associated steatohepatitis | Mochida Pharmaceutical Company, Ltd. | Completed | Missed primary |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT02719327 | Jun 2017 → Sep 2023 | Alzheimer disease | VA Office of Research and Development | Completed | Missed primary |
| Phase 38 trials · 4 met primary | ||||||
| Phase 3 | NCT06710080 | Apr → Dec 2026 expected | atherosclerosis, pneumonia | Ottawa Heart Institute Research Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT04239950 | May 2020 → Jul 2023 | hypertriglyceridemia | Mochida Pharmaceutical Company, Ltd. | Completed | Met primary |
| Phase 3 | NCT03428477 | May 2018 → Nov 2025 overdue | colon carcinoma, metastasis from malignant tumor of colon | Mark A Hull, PhD FRCP | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02708771 | Mar 2016 → Jun 2018 | heart failure | Hospital San Juan de la Cruz | Completed | No outcome recorded |
| Phase 3 | NCT02422446 | Apr 2015 → Mar 2017 | coronary artery disorder, type 2 diabetes mellitus | Brigham and Women's Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01492361 | Nov 2011 → May 2018 | cardiovascular disorder | Amarin Pharma Inc. | Completed | Met primary |
| Phase 3 | NCT01047501 | Dec 2009 → Feb 2011 | hypertriglyceridemia | Amarin Pharma Inc. | Completed | Met primary |
| Phase 3 | NCT01047683 | Dec 2009 → Oct 2010 | hypertriglyceridemia | Amarin Pharma Inc. | Completed | Met primary |
| Phase 44 trials · 3 met primary | ||||||
| Phase 4 | NCT06280976 | Mar 2024 → Jan 2025 | atherosclerosis, coronary artery disorder, myocardial infarction | University of Louisville | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04562467 | Sep 2020 → May 2023 | cardiovascular disorder, hypertriglyceridemia, type 2 diabetes mellitus | Canadian Medical and Surgical Knowledge Translation Research Group | Completed | Met primary |
| Phase 4 | NCT00839449 | Dec 2004 → Jun 2008 | intracranial vasospasm, subarachnoid hemorrhage | Yamaguchi University Hospital | Completed | Met primary |
| Phase 4 | NCT00231738 | Nov 1996 → Nov 2004 | cardiovascular disorder | Kobe University | Completed | Met primary |
| Comparator or background therapy8 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 2 | NCT04177680 Comparator | Jun → Nov 2020 | hypertriglyceridemia | Matinas BioPharma Nanotechnologies, Inc. | Completed | Missed primary |
| Phase 2 | NCT03661047 Comparator | Nov 2019 → Nov 2021 | colon carcinoma | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 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 |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-01-08 | Mochida Pharmaceutical Company, Ltd. | Regulatory 中国におけるエパデールの新薬承認取得のお知らせ mochida.co.jp ↗ |
| 2024-07-02 | Mochida Pharmaceutical Company, Ltd. | Regulatory 中国におけるエパデールの新薬承認申請のお知らせ mochida.co.jp ↗ |
| 2024-04-08 | HLS Therapeutics, Inc | Results New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups hlstherapeutics.com ↗
The REDUCE-IT analysis results relating Lp(a) concentrations with CV risk were also published online today in the Journal of the American College of Cardiology (JACC). |
| 2023-11-14 | HLS Therapeutics, Inc | Results New REDUCE-IT® Analyses Show Vascepa® (Icosapent Ethyl) Associated with 29 Percent Relative Risk Reduction Compared with Placebo in Prespecified Subgroup of Patients with Metabolic Syndrome, but Without Diabetes at Baseline hlstherapeutics.com ↗
These new analyses show that among statin-treated patients in a prespecified subgroup with history of Metabolic Syndrome, but without diabetes at baseline, the addition of Vascepa (icosapent ethyl) significantly reduced the risk of first and total cardiovascular events. |
| 2023-09-23 | Halcygen Pharmaceuticals Limited | Regulatory Strides receives USFDA approval for Icosapent Ethyl Capsules strides.com ↗ |
| 2023-04-24 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Icosapent Ethyl Capsules, 0.5 g and 1 g zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Icosapent Ethyl Capsules, 0.5 g and 1 g (USRLD: Vascepa® Capsules, 0.5 g and 1 g). |
| 2022-11-07 | HLS Therapeutics, Inc | Results HLS Therapeutics Highlights Key Data on the Late Breaking RESPECT-EPA Study Presented at the American Heart Association hlstherapeutics.com ↗
And now, RESPECT-EPA is the third study that demonstrated the value of highly purified EPA in reducing cardiovascular outcomes in patients with CAD. |
| 2021-03-17 | HLS Therapeutics, Inc | Results HLS Therapeutics Announces that VASCEPA® (Icosapent Ethyl) is Found in Prespecified and Post Hoc Analyses to Significantly Reduce Stroke in At-Risk Patients in Analyses of Landmark REDUCE-IT® Study Presented at International Stroke Conference 2021 hlstherapeutics.com ↗
The findings of benefit in at-risk patients include significant reductions in overall strokes and in ischemic strokes. |
| 2020-12-14 | HLS Therapeutics, Inc | Results HLS Therapeutics Reports Efficacy and Safety Results from Pilot Study Treating COVID-19 Infected Outpatients with Vascepa® (Icosapent Ethyl) hlstherapeutics.com ↗
Vascepa administration resulted in a significant 52% reduction of the total patient-reported symptom outcome prevalence score as compared to a 24% reduction in the usual care group |
| 2020-11-16 | HLS Therapeutics, Inc | Results VASCEPA® (Icosapent Ethyl) Found to Significantly Reduce Ischemic Events in Patients with Prior Coronary Artery Bypass Grafting Procedures hlstherapeutics.com ↗
The use of VASCEPA resulted in absolute risk reductions of MACE equal to, or greater than, 6.0% in these subgroup analyses, avoiding on average one cardiac event for every 17 patients treated |
| 2020-10-22 | HLS Therapeutics, Inc | Results HLS Therapeutics Highlights Latest Icosapent Ethyl Research Presented at the Canadian Cardiovascular Congress hlstherapeutics.com ↗
Icosapent ethyl reduces cellular inflammation1, which may be a factor in plaque regression in the arteries as seen in the EVAPORATE5 trial that enrolled both diabetic and non-diabetic high-risk patients. |
| 2020-08-31 | HLS Therapeutics, Inc | Results VASCEPA® (Icosapent Ethyl) Reported to Significantly Reduce Coronary Plaque in EVAPORATE Study Final Results Presented at ESC Congress 2020 hlstherapeutics.com ↗
VASCEPA® (icosapent ethyl) demonstrated significant, 17% regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT) compared with placebo over 18 months. |
| 2020-07-20 | HLS Therapeutics, Inc | Regulatory HLS Therapeutics welcomes both CADTH's recommendation to reimburse Vascepa® (icosapent ethyl) for patients with established cardiovascular disease and PMPRB's notification on its introductory price hlstherapeutics.com ↗
CADTH recommends Vascepa be reimbursed for patients with established cardiovascular disease under certain conditions. |
| 2020-01-06 | HLS Therapeutics, Inc | Regulatory HLS Therapeutics Announces 8 Years of Data Protection for Vascepa® hlstherapeutics.com ↗
HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, announces that today Vascepa® was added to Health Canada's Register of Innovative Drugs and as a result it will benefit from data protection for a term of eight years from the date of the issuance of the notice of compliance. |
| 2019-12-31 | HLS Therapeutics, Inc | Regulatory HLS Therapeutics Announces Health Canada Approval for Vascepa® to Reduce the Risk of Cardiovascular Events hlstherapeutics.com ↗ |
| 2019-11-15 | HLS Therapeutics, Inc | Regulatory HLS Therapeutics Reports on U.S. FDA Advisory Committee Recommendation for Vascepa hlstherapeutics.com ↗ |
| 2019-04-29 | HLS Therapeutics, Inc | Regulatory HLS Therapeutics Files New Drug Submission for Vascepa® in Canada hlstherapeutics.com ↗
HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focused on central nervous system and cardiovascular markets, announces that it has filed a New Drug Submission ("NDS") with Health Canada for Vascepa®. |
| 2019-03-29 | HLS Therapeutics, Inc | Regulatory HLS Therapeutics Granted Priority Review Status from Health Canada for Vascepa® hlstherapeutics.com ↗
HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a specialty pharmaceutical company focused on central nervous system and cardiovascular markets, announces that Health Canada has granted priority review status for its New Drug Submission ("NDS") for Vascepa®, which seeks to reduce the risk of ischemic cardiovascular events in statin-treated patients with elevated triglycerides and other risk factors. |
| 2019-03-19 | HLS Therapeutics, Inc | Results HLS Therapeutics Announces Vascepa® (icosapent ethyl) Showed 30% Reduction in Total Cardiovascular Events Including Recurrent Events in REDUCE-IT™ hlstherapeutics.com ↗ |
| 2018-11-12 | HLS Therapeutics, Inc | Results HLS Therapeutics Announces that Amarin's Vascepa ® (icosapent ethyl) Demonstrates 26% Reduction in Key Secondary Composite Endpoint of Cardiovascular Death, Heart Attack and Stroke in REDUCE-IT™, which Supports 25% Overall Reduction in Five-Point Major Adverse Cardiovascular Event Primary Composite Endpoint hlstherapeutics.com ↗
REDUCE-IT primary results confirmed 25% relative risk reduction ("RRR") for the topline primary endpoint result with multiple robust demonstrations of efficacy, including 20% reduction in cardiovascular death. |
| 2018-09-24 | HLS Therapeutics, Inc | Results HLS Therapeutics Announces that Amarin's REDUCE-IT™ Cardiovascular Outcomes Study of Vascepa® (icosapent ethyl) Capsules Met Primary Endpoint hlstherapeutics.com ↗ |
| 2015-06-15 | Matinas BioPharma Nanotechnologies, Inc. | Results Matinas BioPharma's MAT9001 Demonstrates Superiority in Reducing Triglycerides, Lipids, Apolipoproteins and PCSK9 Levels in Head-to-Head Study With Vascepa(R) matinasbiopharma.com ↗ |
All press releases naming this drug 46 releases
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 ↗ |