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icosapent ethyl

Trade name: vascepa

Small moleculeapproved

Approved

Nov 10, 2004

Icosapent is an important polyunsaturated fatty acid found in fish oils. It serves as the precursor for the prostaglandin-3 and thromboxane-3 families. A diet rich in eicosapentaenoic acid lowers serum lipid concentration, reduces incidence of cardiovascular disorders, prevents platelet aggregation, and inhibits arachidonic acid conversion into the thromboxane-2 and prostaglandin-2 families. EPA can be used for lowering elevated triglycerides in those who are hyperglyceridemic. In addition, EPA may play a therapeutic role in patients with cystic fibrosis by reducing disease severity and may play a similar role in type 2 diabetics in slowing the progression of diabetic nephropathy. — NCATS

Clinical trial activity

562 trials · 495 clinical orgs · 19 marketing orgs

Phase 1
66
Phase 2
202
Phase 3
128
Phase 4
93

Earliest trial started Dec 1, 1986 (NCT00000461)

Timeline

1980s

  1. Jan 1, 1986

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1989

    Earliest Phase 3 Sponsor(trial)

1990s

  1. Jan 1, 1995

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Nov 10, 2004

    Earliest FDA Approval

  2. Nov 10, 2004

    SmithKline Beecham — NDA Secondary Org

  3. Jul 14, 2008

    Amarin — IND Organization

  4. Jul 14, 2008

    Amarin — IND Organization

2010s

  1. Jul 26, 2012

    Amarin — First NDA Organization

  2. Jul 26, 2012

    Amarin — NDA Secondary Org

  3. Jul 26, 2012

    Amarin — NDA Organization

  4. Apr 7, 2014

    Teva — Marketing Organization

  5. Apr 23, 2014

    Osmotica Pharmaceutical — NDA Secondary Org

  6. Jun 24, 2014

    Par Pharmaceuticals — Marketing Organization

  7. Sep 30, 2014

    Apotex — Marketing Organization

  8. Nov 27, 2015

    Amneal Pharmaceuticals — Marketing Organization

  9. Sep 19, 2017

    Strides Pharma Science — Marketing Organization

  10. Feb 25, 2019

    Ascent Pharmahealth — Marketing Organization

  11. Jun 14, 2019

    Zydus Discovery DMCC — Marketing Organization

  12. Jul 10, 2019

    Sofgen Pharmaceuticals — Marketing Organization

2020s

  1. May 21, 2020

    Hikma — Marketing Organization

  2. Aug 7, 2020

    Dr. Reddy's Laboratories — Marketing Organization

  3. Sep 22, 2023

    ONESOURCE SPECIALTY — Marketing Organization

  4. Dec 22, 2023

    Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization

  5. Nov 20, 2024

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

  6. Dec 20, 2024

    PHARMOBEDIENT — Marketing Organization

  7. Dec 20, 2024

    Torrent Pharmaceuticals Limited — Marketing Organization

  8. Aug 6, 2025

    LP Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

    Mode of action not fully understood; it seems to increase beta-oxidation, inhibit acyl-CoA:1,2-diacylglycerol acyltransferase (EC 2.3.1.20), decreas lipogenesis in the liver, and increase plasma lipoprotein lipase activity

Approval history

  • approvedNov 10, 2004

Chemistry & pharmacology

Loading structure…

SMILES

CC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CCCC(O)=O
Mol. weight
302.451 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 5,8,11,14,17-eicosapentaenoic acid
  • 5,8,11,14,17-eicosapentaenoic acid
  • 5,8,11,14,17-eicosapentaenoic acid, ethyl ester, (5z,8z,11z,14z,17z)-
  • 5,8,11,14,17-icosapentaenoic acid
  • 5,8,11,14,17-icosapentaenoic acid
  • (5z,8z,11z,14z,17z)-5,8,11,14,17-eicosapentaenoic acid
  • (5z,8z,11z,14z,17z)-5,8,11,14,17-eicosapentaenoic acid
  • (5z,8z,11z,14z,17z)-eicosapentaenoate
  • (5z,8z,11z,14z,17z)-eicosapentaenoate
  • (5z,8z,11z,14z,17z)-eicosapentaenoic acid
  • (5z,8z,11z,14z,17z)-eicosapentaenoic acid
  • (5z,8z,11z,14z,17z)-icosapentaenoic acid
  • (5z,8z,11z,14z,17z)-icosapentaenoic acid
  • all-cis-4,7,10,13,16,19-docosahexaenoic acid
  • all-cis-4,7,10,13,16,19-docosahexaenoic acid
  • all-cis-5,8,11,14,17-eicosapentaenoic acid
  • all-cis-5,8,11,14,17-eicosapentaenoic acid
  • all-cis-5,8,11,14,17-icosapentaenoic acid
  • all-cis-5,8,11,14,17-icosapentaenoic acid
  • all-cis-icosa-5,8,11,14,17-pentaenoic acid
  • all-cis-icosa-5,8,11,14,17-pentaenoic acid
  • (all-z)-5,8,11,14,17-eicosapentaenoic acid
  • (all-z)-5,8,11,14,17-eicosapentaenoic acid
  • amr101
  • amr-101
  • amr-101
  • amr-101
  • cis-5,8,11,14,17-eicosapentaenoic acid
  • cis-5,8,11,14,17-eicosapentaenoic acid
  • cis-5,8,11,14,17-epa
  • cis-5,8,11,14,17-epa
  • cis, cis, cis, cis, cis-eicosa-5,8,11,14,17-pentaenoic acid
  • cis-delta(5,8,11,14,17)-eicosapentaenoic acid
  • cis-delta(5,8,11,14,17)-eicosapentaenoic acid
  • dualtis
  • eicosapentaenoic acid
  • eicosapentaenoic acid
  • eicosapentaenoic acid
  • eicosapentaenoic acid
  • eicosapentaenoic acid
  • eicosapentaenoic acid
  • eicosapentaenoic acid
  • eicosapentaenoic acid
  • eicosapentaenoic acid ethyl ester
  • eicosapentaenoic acid ethyl ester
  • eicosapentaenoic acid ethyl ester
  • eicosapentanoic acid
  • eicosapentanoic acid
  • epa
  • epa
  • epadel
  • epa-e
  • ethyl (5z,8z,11z,14z,17z)-icosa-5,8,11,14,17-pentaenoate
  • ethyl all-cis-5,8,11,14,17-icosapentaenoate
  • ethyl eicosapent
  • ethyl-eicosapent
  • ethyl-eicosapent
  • ethyl-eicosapent
  • ethyl-eicosapent
  • ethyl-eicosapent
  • ethyl eicosapentaenoate
  • ethyl eicosapentaenoate
  • ethyl eicosapentaenoate
  • ethyl eicosapentaenoate
  • ethyl eicosapentaenoic acid
  • ethyl-eicosapentaenoic acid
  • ethyl-eicosapentaenoic acid
  • ethyl-eicosapentaenoic acid
  • ethyl-eicosapentaenoic acid
  • ethyl-eicosapentaenoic acid
  • ethyl-epa
  • ethyl-epa
  • ethyl-epa
  • ethyl icosapentaenoate
  • ethyl icosapentate
  • ethyl icosapentate
  • ethyl icosapentate
  • ethyl icosapentate
  • ethyl icosapentate
  • gsk2212836
  • icosapent
  • icosapent
  • icosapent
  • icosapent
  • icosapent
  • icosapent
  • icosapent
  • icosapentaenoic acid
  • icosapentaenoic acid
  • icosapentaenoic acid
  • icosapent (epa ethyl ester)
  • icosapent (epa ethyl ester)
  • icosapent ethyl
  • icosapent ethyl
  • icosapent ethyl
  • icosapent ethyl
  • icosapent ethyl
  • icosapent ethyl
  • icosapent ethyl
  • icosapent ethyl
  • icosapent ethyl
  • icosapent ethyl
  • icosapento
  • icosapento
  • icosapentum
  • icosapentum
  • k85
  • lovaza
  • lovaza
  • lovaza
  • lovaza
  • n-3 fatty acids
  • n-3 fatty acids
  • n-6 fatty acids
  • n-6 fatty acids
  • nebbaro
  • omacor
  • omacor
  • omacor
  • omacor, lovaza
  • omega 3
  • omega-3
  • omega-3 acid
  • omega-3-acid ethyl ester
  • omega-3 acid ethyl esters
  • omega-3 acid ethyl esters
  • omega-3 acid triglycerides
  • omega-3 acid triglycerides
  • omega-3 ethyl ester 90
  • omega-3-ethyl esters
  • omega 3 fatty acid
  • omega 3 fatty acid
  • omega 3-fatty acid
  • omega 3-fatty acid
  • omega-3 fatty acid
  • omega-3 fatty acid
  • omega-3 fatty acid
  • omega-3-fatty acid
  • omega-3-fatty acid
  • omega 3 fatty acides
  • omega 3 fatty acids
  • omega 3 fatty acids
  • omega 3 fatty acids
  • omega-3 fatty acids
  • omega-3 fatty acids
  • omega-3 fatty acids
  • omega-3 marine triglycerides
  • omega-3 marine triglycerides
  • omega-3 phospholipids
  • omega-3 polyunsaturated fatty acids
  • omega-3 polyunsaturated fatty acids
  • omega-3 polyunsaturates
  • omega-3 polyunsaturates
  • phospholipids
  • phospholipids
  • p-om3 adjunct
  • prestylon
  • teromeg
  • timnodonic acid
  • timnodonic acid
  • timnodonic acid
  • timnodonic acid ethyl ester
  • vascepa
  • vascepa
  • vascepa
  • vascepa
  • vascepa
  • vascepa
  • ω-3 fatty acids
  • ω-3 fatty acids

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07056439Phase 1/Phase 2 (Phase 2)Jul 31, 2025Hengrui Therapeutics, Inc.
NCT06720662N/AApr 1, 2025University of Sao Paulo
NCT06758778N/AJan 3, 2025SICHUAN CREDIT PHARMACEUTICAL CO., LTD.
NCT06710080Phase 3Dec 15, 2024University of Ottawa
NCT06466278Phase 2Jun 1, 2023University of Amsterdam
NCT05198843Phase 1/Phase 2 (Phase 2)Mar 25, 2022National Cancer Institute (NCI), University of Texas at Houston
NCT04811404Phase 4Mar 19, 2021Columbia University
NCT04562467Phase 4Sep 24, 2020Canadian Medical and Surgical Knowledge Translation Research Group, Harvard University, HLS Therapeutics, Inc, Unity Health Toronto, University of Toronto, University of Western Ontario
NCT04460651Phase 3Aug 14, 2020Amarin, Estudios Clínicos Latino América
NCT04505098Phase 4Aug 7, 2020Amarin, Kaiser Permanente
NCT04412018Phase 2Jun 30, 2020Amarin, Canadian Medical and Surgical Knowledge Translation Research Group, HLS Therapeutics, Inc
NCT04177680Phase 2Feb 29, 2020Matinas Biopharma, Inc, MB Clinical Research and Consulting LLC
NCT04221217Phase 3Feb 1, 2020Mochida Pharmaceutical Company, Ltd.
NCT04216251Phase 1/Phase 2 (Phase 2)Jan 31, 2020Harvard University, National Institutes of Health (NIH)
NCT04239950Phase 3Jan 20, 2020Mochida Pharmaceutical Company, Ltd., Sumitomo
NCT04172636Phase 2Jan 1, 2020Harvard University
NCT03598309Phase 2Nov 30, 2018James and Esther King Biomedical Research Program, University of South Florida
NCT03693131Phase 3Oct 31, 2018Mochida Pharmaceutical Company, Ltd.
NCT03661047Phase 2Sep 30, 2018Harvard University
NCT03657758Phase 4Sep 17, 2018Kobe University
Showing 20 of 562 trials
Page 1 / 29

Organizations

Research & Development (495)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit45752005
Harvard UniversityAcademic/Hospital413341986
National Heart, Lung, and Blood Institute (NHLBI)Government18441986
Pronova BioPharmaFor profit16651995
National Institutes of Health (NIH)Government15041997
National Cancer Institute (NCI)Government14341995
AstraZenecaFor profit111032001
National Center for Complementary and Integrative Health (NCCIH)Government11242000
National Institute of Mental Health (NIMH)Government11141999
Ohio State UniversityAcademic/Hospital11942006
Tel Aviv UniversityAcademic/Hospital11832004
AmarinFor profit9442005
Government of TaiwanGovernment9522003
Isfahan UniversityAcademic/Hospital9822007
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government9341997
Aalborg UniversityAcademic/Hospital8542006
Department of Veteran AffairsGovernment8342004
Friedrich Schiller UniversityAcademic/Hospital8822004
Reliant PharmaceuticalsFor profit8032006
University of GuelphAcademic/Hospital8542004
495 organizations
Page 1 / 25

Marketing (24)

OrganizationOrg typeRelationshipDate
AmarinFor profitNDA2Jul 26, 2012
AmarinFor profitNDAJul 26, 2012
AmarinFor profitINDJul 14, 2008
Amneal PharmaceuticalsFor profitMKTGNov 27, 2015
ApotexFor profitMKTGSep 30, 2014
ApotexFor profitSYNJun 30, 2021
Ascent PharmahealthFor profitMKTGFeb 25, 2019
Dr. Reddy's LaboratoriesFor profitMKTGAug 7, 2020
HikmaFor profitMKTGMay 21, 2020
HikmaFor profitSYNMay 21, 2020
LP PharmaceuticalsFor profitMKTGAug 6, 2025
ONESOURCE SPECIALTYFor profitMKTGSep 22, 2023
Osmotica PharmaceuticalFor profitNDA2Apr 23, 2014
PHARMOBEDIENTFor profitMKTGDec 20, 2024
Par PharmaceuticalsFor profitMKTGJun 24, 2014
Qilu Pharmaceutical Co., Ltd.For profitMKTGNov 20, 2024
SmithKline BeechamFor profitNDA2Nov 10, 2004
Sofgen PharmaceuticalsFor profitMKTGJul 10, 2019
Strides Pharma ScienceFor profitMKTGSep 19, 2017
TevaFor profitMKTGApr 7, 2014
Torrent Pharmaceuticals LimitedFor profitMKTGDec 20, 2024
Yichang Humanwell Pharmaceutical Co.,LtdFor profitMKTGDec 22, 2023
Zydus Discovery DMCCFor profitMKTGJun 14, 2019
Zydus Discovery DMCCFor profitSYNApr 20, 2023