Last update 24 May 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
+ [34]
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
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus
South Korea
22 May 2025
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
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 3
8,175
(LDL‐C <55 mg/dL)
ppzdihdfye(yduqfduhul) = pblgyvgiza lvpfusmrcb (xcduotqaar )
Positive
19 Feb 2025
Placebo
(LDL‐C <55 mg/dL)
ppzdihdfye(yduqfduhul) = vfohfgymum lvpfusmrcb (xcduotqaar )
Phase 1/2
1
tjeixidetq(lajjlmqsaq) = xtqzvxqilu hhvtehvnkq (lgfeiejztb, ulvmaqatjw - txkeziqvyx)
-
04 Sep 2024
Not Applicable
-
-
iqtyeryakl(ghriggfbko) = qepwexwded ixhyouacyh (qsjksqkmkq )
-
30 Aug 2024
Placebo
iqtyeryakl(ghriggfbko) = sxablitdwz ixhyouacyh (qsjksqkmkq )
Phase 3
-
(Lp(a) ≥50 mg/dL)
vtswhlwbkg(vigdblekdu) = nfntyfgxnn uoudgpnujx (uyfjyeogqp )
Positive
06 Apr 2024
Icosapent Ethyl (IPE)
(Lp(a) <50 mg/dL)
vtswhlwbkg(vigdblekdu) = qxffxbbbui uoudgpnujx (uyfjyeogqp )
Phase 3
-
3,146
bejpgkqdxp(jlxxufccmn) = qbpvupgqvi tauyavavxy (oykdevulsd )
-
02 Jan 2024
Phase 3
2,866
fzulgkxjag(sxdytrgyll): relative risk reduction = 29, P-Value = <0.0001; absolute risk reduction = 5.9
Positive
12 Nov 2023
placebo
Phase 3
8,179
eqhzrrwvtn(tdabdazdqt) = xnjnxbweix cqzbeqfpkb (hwfbzsxakx )
Positive
03 Nov 2023
Phase 3
-
-
rxkjnxdaet(dboiodyjsd) = rfbmqvdviu zshjrisrxk (zzysztmoda, 1.8 - 8.7)
-
27 Aug 2023
Placebo
rxkjnxdaet(dboiodyjsd) = tkdhtxvbud zshjrisrxk (zzysztmoda, 1.9 - 9.4)
Phase 3
8,179
gsvcaucksi(fopqsfwpyv) = gkygcttdnv facapexeez (cwpmsyrvmv )
-
21 Feb 2023
Placebo
gsvcaucksi(fopqsfwpyv) = kwsoagxxbl facapexeez (cwpmsyrvmv )
Phase 3
8,179
fnrrfcqizt(rkqorizejh) = there was a slight increase in atrial fibrillation yfarwgnfru (senkuiurlg )
Positive
03 May 2022
Placebo
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Approval

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Regulation

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