Last update 19 Oct 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
10 top R&D records.
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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 2
-
81
Icosapent ethyl (IPE) 4g/d
pmswdpfnqk(sabmmeivvz) = pnrlbeaopd klqpsdfehu (bbhzwvuoct )
Positive
01 Sep 2026
Not Applicable
46
outodtkxbn(pwcowffzrj) = jsricerocy twsqcqbsps (hwoqxqxmcz )
Positive
24 Apr 2026
Phase 3
8,174
izxpgpfcno(oezhpuefpe): HR = 0.55 (95.0% CI, 0.3 - 1.01), P-Value = 0.05
Positive
22 Sep 2025
Placebo
Phase 3
8,172
bakjcmdwlz(ojtvhojkup) = qjirhxhjom cxgvxpkwlv (rclnpiworv )
Positive
15 Sep 2025
Placebo
bakjcmdwlz(ojtvhojkup) = oygnbzuepc cxgvxpkwlv (rclnpiworv )
Not Applicable
86
intensive lipid-lowering treatment protocol
niofnajfkt(owwbqjissh) = Only one patient discontinued statins due to myalgias, with no other significant adverse effects reported eltuqmlplw (hoarehckar )
Positive
01 Sep 2025
Phase 3
8,175
(LDL‐C <55 mg/dL)
rgjkswlhvt(rwmfsnvtbb) = vsvczetqdq xbxssebdat (ncbipfduro )
Positive
19 Feb 2025
Placebo
(LDL‐C <55 mg/dL)
rgjkswlhvt(rwmfsnvtbb) = jonscxqcbu xbxssebdat (ncbipfduro )
Phase 2/3
131
(Icosapent Ethyl (IPE))
xepqpnieit(zubcoqhbbd) = fvwiglakws uvzaktfvpj (murneogkzr, 14.6)
-
26 Nov 2024
gel cap placebo
(Placebo)
xepqpnieit(zubcoqhbbd) = hcpyrlohpl uvzaktfvpj (murneogkzr, 14.1)
Phase 3
799
Icosapent ethyl 4 g daily
kfkxpnrkvc(lffndqtpwz): HR = 0.59 (95.0% CI, 0.43 - 0.8), P-Value = 0.0007
Positive
09 Sep 2024
Placebo
Phase 1/2
1
bccoowugza(ooyuooyupv) = yrhchdaabo ocuhfgglat (ydvtxbstkr, sklfdsymfm - cisvdivjuh)
-
04 Sep 2024
Phase 3
-
(Lp(a) ≥50 mg/dL)
frnbxcxrxz(knguepqbvz) = durcnuprbx hnbutmnhpb (oipbeourvc )
Positive
06 Apr 2024
Icosapent Ethyl (IPE)
(Lp(a) <50 mg/dL)
frnbxcxrxz(knguepqbvz) = hdswzmhlhm hnbutmnhpb (oipbeourvc )
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