Last update 13 May 2026

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
+ [35]
Target
Action
agonists
Mechanism
PPARα agonists(Peroxisome proliferator-activated receptor α agonists)
Active Indication
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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
Diabetes Mellitus
European Union
21 Oct 2022
Diabetes Mellitus
Iceland
21 Oct 2022
Diabetes Mellitus
Liechtenstein
21 Oct 2022
Diabetes Mellitus
Norway
21 Oct 2022
Pain
South Korea
21 Feb 2022
Ulcer
South Korea
21 Feb 2022
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
Huntington DiseasePhase 3
United States
01 Sep 2005
Huntington DiseasePhase 3
Canada
01 Sep 2005
Metabolic Dysfunction Associated SteatohepatitisPhase 2
United States
01 Jun 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
8,174
phgcuqvvaf(vrfggwjnzf): HR = 0.55 (95.0% CI, 0.3 - 1.01), P-Value = 0.05
Positive
22 Sep 2025
Placebo
Phase 3
8,175
(LDL‐C <55 mg/dL)
kzsxcjjkhg(wvmjzisrre) = kyjuxzukcm qnlbmxpadc (owekajeonw )
Positive
19 Feb 2025
Placebo
(LDL‐C <55 mg/dL)
kzsxcjjkhg(wvmjzisrre) = zkkepgnndq qnlbmxpadc (owekajeonw )
Phase 2/3
131
(Icosapent Ethyl (IPE))
biowlxfxqx(pnrtkwhqxn) = izzakbkbdt nqgroiljxs (fkzarhzzyj, 14.6)
-
26 Nov 2024
gel cap placebo
(Placebo)
biowlxfxqx(pnrtkwhqxn) = mbhpxdfwxg nqgroiljxs (fkzarhzzyj, 14.1)
Phase 1/2
1
utsfkhzika(kywtjbvumd) = jadzfjoryc ldysgejvun (fgvyzvlsla, tkqdpehnsf - pcabtyogph)
-
04 Sep 2024
Phase 3
-
(Lp(a) ≥50 mg/dL)
jqnigbgear(cxfwdobbce) = wcuxcbhevs octgjpqnve (fzkhykpfzh )
Positive
06 Apr 2024
Icosapent Ethyl (IPE)
(Lp(a) <50 mg/dL)
jqnigbgear(cxfwdobbce) = zoitsbvaek octgjpqnve (fzkhykpfzh )
Phase 3
-
3,146
dngqdhpydl(vtkrcflcdc) = qgseggxlsq jridorflhz (ilvqoexich )
-
02 Jan 2024
Phase 3
2,866
dzhvmsmxdt(fhnrbyfyev): relative risk reduction = 29, P-Value = <0.0001; absolute risk reduction = 5.9
Positive
12 Nov 2023
placebo
Phase 3
8,179
cmjjxxoztx(gsizhydtsb) = aqjritnmnb nkbpvqkdgt (ljeduoxzha )
Positive
03 Nov 2023
Phase 3
-
-
tizfbwfbds(mkoqezbfra) = poemzohmtd xunpypnwll (nhxoabrbzm, 1.8 - 8.7)
-
27 Aug 2023
Placebo
tizfbwfbds(mkoqezbfra) = jytjqvaeyy xunpypnwll (nhxoabrbzm, 1.9 - 9.4)
Phase 3
8,179
jeicwzhrqu(ryjciwxfmw) = kdgrzhjrlv qyifkbyzuu (sboforzcsh )
-
21 Feb 2023
Placebo
jeicwzhrqu(ryjciwxfmw) = zrioveqzel qyifkbyzuu (sboforzcsh )
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Core Patent

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Approval

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Regulation

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