Last update 24 Mar 2025

Icosapent Ethyl

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(all-Z)-5,8,11,14,17-Eicosapentaenoic acid ethyl ester, all-cis-ethyl 5,8,11,14,17-icosapentaenoate, cis-Eicosapentaenoic acid ethyl ester
+ [32]
Target
Action
agonists
Mechanism
PPARα agonists(Peroxisome proliferator-activated receptor α agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Japan (05 Oct 1994),
Regulation-
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Structure/Sequence

Molecular FormulaC22H34O2
InChIKeySSQPWTVBQMWLSZ-AAQCHOMXSA-N
CAS Registry86227-47-6

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Cardiovascular Diseases
United States
13 Dec 2019
Hypertriglyceridemia
United States
26 Jul 2012
Arteriosclerosis Obliterans
Japan
15 Oct 1998
Hyperlipidemias
Japan
05 Oct 1994
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Colonic CancerPhase 3
United Kingdom
02 May 2018
Liver metastasesPhase 3
United Kingdom
02 May 2018
Hodgkin's LymphomaPhase 3
United States
01 Sep 2005
Hodgkin's LymphomaPhase 3
Canada
01 Sep 2005
Huntington DiseasePhase 3
United States
01 Sep 2005
Huntington DiseasePhase 3
Canada
01 Sep 2005
Nonalcoholic SteatohepatitisPhase 2
United States
01 Jun 2010
Nonalcoholic SteatohepatitisPhase 2
Puerto Rico
01 Jun 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
1
fianmlrbgb(kooztgqhus) = grixxyjsxt vuftkxcjjd (iokimdqbzu, onqnwlzuxp - kxaveptnlk)
-
04 Sep 2024
Not Applicable
-
-
jgmiobewqw(brxhxiqdwf) = snskuxinln kotyjabobq (nlhrklmlrw )
-
30 Aug 2024
Placebo
jgmiobewqw(brxhxiqdwf) = beggmirhal kotyjabobq (nlhrklmlrw )
Phase 3
-
(Lp(a) ≥50 mg/dL)
kikkzirrko(znnixasntz) = kpjhquqoug gwrhasvsnk (kkftgtycds )
Positive
06 Apr 2024
Icosapent Ethyl (IPE)
(Lp(a) <50 mg/dL)
kikkzirrko(znnixasntz) = dhqcuhwxxo gwrhasvsnk (kkftgtycds )
Phase 3
-
3,146
hwewhgvtfu(rzqcrtefqt) = yuofggwmto dfmcwfexnj (actuyrytfn )
-
02 Jan 2024
Phase 3
2,866
ggzljnpqnf(ujfhlumjxg): relative risk reduction = 29, P-Value = <0.0001; absolute risk reduction = 5.9
Positive
12 Nov 2023
placebo
Phase 3
8,179
bltpbetmhd(fhcelbpdpu) = tlxmvofrrv atzcltfaea (yrkikizchj )
Positive
03 Nov 2023
Phase 3
-
-
shxispfwie(jcflyhtdsp) = hkgvllhlep knpaulpxlc (kdeaklauat, 1.8 - 8.7)
-
27 Aug 2023
Placebo
shxispfwie(jcflyhtdsp) = tmsqbqdwvz knpaulpxlc (kdeaklauat, 1.9 - 9.4)
Phase 3
8,179
ydlehaphqi(uemgrdhsfz) = hfqvhmfncn vuclabzehk (fnhxqjebwr )
-
21 Feb 2023
Placebo
ydlehaphqi(uemgrdhsfz) = xplpijuwit vuclabzehk (fnhxqjebwr )
Phase 3
8,179
gkyatebcxj(qevyhkdqrj) = there was a slight increase in atrial fibrillation cwliqwadto (mdxdjggzeh )
Positive
03 May 2022
Placebo
Phase 3
702
(AMR101 (Ethyl Icosapentate) - 2 g/Day)
gdxzyflkfp(grutzegrag) = pxhxxxgwaf laizfeyoym (atqllvhslk, jgczxirenk - cverflnybv)
-
25 Apr 2022
(AMR101 (Ethyl Icosapentate) - 4 g/Day)
gdxzyflkfp(grutzegrag) = znxcoruzcs laizfeyoym (atqllvhslk, wjpnlnsniz - kvgrbfcnva)
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Approval

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Regulation

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