omega-3-carboxylic acids

Trade name: epanova

Small moleculeapproved

Approved

May 5, 2014

Omega−3-carboxylic acids (Epanova) is a formerly marketed yet still not a Food and Drug Administration (FDA)-approved prescription medication–since taken off market by the manufacturer–used alongside a low fat and low cholesterol diet that lowers high triglyceride (fat) levels in adults with very high levels. This was the third class of fish oil-based drug, after omega−3-acid ethyl esters and ethyl eicosapentaenoic acid (Vascepa), to be approved for use as a drug. The first approval in the United States by the FDA was granted 05 May 2014. These fish oil drugs are similar to fish oil dietary supplements, but the ingredients are better controlled and have been tested in clinical trials. Specifically, Epanova contained at least 850 mg omega−3-acid ethyl esters per 1 g capsule. — Wikipedia

Clinical trial activity

14 trials · 16 clinical orgs · 2 marketing orgs

Phase 1
6
Phase 2
8
Phase 3
6
Phase 4
0

Earliest trial started Sep 1, 2002 (NCT00074542)

Timeline

2000s

  1. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2010

    AstraZeneca — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2013

    AstraZeneca — Earliest Phase 1 Sponsor(trial)

  3. May 5, 2014

    Omthera Pharmaceuticals — Earliest FDA Approval

  4. May 5, 2014

    AstraZeneca — Marketing Organization

  5. May 5, 2014

    AstraZeneca — NDA Secondary Org

  6. May 5, 2014

    Omthera Pharmaceuticals — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedMay 5, 2014

Chemistry & pharmacology

Loading structure…

SMILES

CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCC(=O)O.CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)O.CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCCC(=O)O.CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCCCC(=O)O.CC/C=C\C/C=C\C/C=C\C/C=C\CCCCCCC(=O)O.CC/C=C\C/C=C\C/C=C\CCCCCCCC(=O)O.CCCCC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCC(=O)O.CCCCC/C=C\C/C=C\C/C=C\CCCCC(=O)O.CCCCC/C=C\C/C=C\CCCCCCCC(=O)O
Mol. weight
2750.26 g/mol
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • azd0585
  • epanova
  • epanova
  • epanova
  • long chain omega-3 and omega-6 fatty acids
  • omega-3 carboxylic acid
  • omega-3-carboxylic acids
  • omega-3-carboxylic acids
  • omega-3-carboxylic acids
  • omega-3-carboxylic acids
  • omega-3-carboxylic acids
  • omega-3-carboxylic acids
  • omega-3-carboxylic acids

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03574142Phase 1Jun 4, 2018AstraZeneca, Capital Medical University
NCT02463071Phase 3Jun 10, 2015AstraZeneca, Koyokai Nakajima Hospital
NCT02372344Phase 1Mar 1, 2015AstraZeneca, Sugioka Memorial Hospital
NCT02370537Phase 2Mar 1, 2015AstraZeneca
NCT02359045Phase 1Feb 12, 2015AstraZeneca, Parexel
NCT02104817Phase 3Oct 30, 2014Adelaide Clinical Research, AstraZeneca, IQVIA, University of Rochester
NCT02189252Phase 1Oct 1, 2014AstraZeneca, Biofortis
NCT02209766Phase 1Aug 1, 2014AstraZeneca, CPC Clinical Trial Hospital
NCT02009865Phase 3Dec 1, 2013AstraZeneca
NCT02859129Phase 1Sep 1, 2013AstraZeneca, Celerion, Omthera Pharmaceuticals
NCT01408303Phase 3Aug 1, 2011AstraZeneca, Medpace, Inc., Omthera Pharmaceuticals
NCT01208961Phase 2Sep 1, 2010AstraZeneca, Radiant Research
NCT00613197Phase 3Jan 1, 2003Katholieke Universiteit Leuven, Tillotts Pharma
NCT00074542Phase 3Sep 1, 2002Tillotts Pharma
Showing 14 of 14 trials
Page 1 / 1

Organizations

Research & Development (16)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit121232010
Omthera PharmaceuticalsFor profit2022011
Tillotts PharmaFor profit2212002
Adelaide Clinical ResearchAcademic/Hospital1012014
BiofortisFor profit1012014
Capital Medical UniversityAcademic/Hospital1012018
CelerionFor profit1012013
CPC Clinical Trial HospitalAcademic/Hospital1012014
IQVIAFor profit1012014
Katholieke Universiteit LeuvenAcademic/Hospital1012003
Koyokai Nakajima HospitalAcademic/Hospital1012015
Medpace, Inc.For profit1012011
ParexelFor profit1012015
Radiant ResearchAcademic/Hospital1012010
Sugioka Memorial HospitalAcademic/Hospital1012015
University of RochesterAcademic/Hospital1012014
16 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
AstraZenecaFor profitMKTGMay 5, 2014
AstraZenecaFor profitNDA2May 5, 2014
Omthera PharmaceuticalsFor profitNDAMay 5, 2014