fish oil

Trade name: Omegavan

Animal productapprovedOrphan Drug FDA

Approved

Jul 13, 2016

Fish oil is oil derived from the tissues of oily fish. Fish oils contain the omega−3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), precursors of certain eicosanoids that are known to reduce inflammation in the body and improve hypertriglyceridemia. There has been a great deal of controversy in the 21st century about the role of fish oil in cardiovascular disease, with recent meta-analyses reaching different conclusions about its potential impact. — Wikipedia

Clinical trial activity

390 trials · 379 clinical orgs · 1 marketing orgs

Phase 1
33
Phase 2
109
Phase 3
58
Phase 4
30

Earliest trial started Nov 1, 1989 (NCT01353807)

Timeline

1990s

  1. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  3. Feb 27, 2008

    Orphan Drug Designation

2010s

  1. Jul 13, 2016

    Fresenius — Earliest FDA Approval

  2. Jul 13, 2016

    Fresenius — NDA Organization

  3. Jul 27, 2018

    Fresenius — NDA Secondary Org

Indications

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Supplement

  • UnclearUnclear

    Unclear unclear

Combination products

Approval history

  • approvedJul 13, 2016

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
Mol. weight
328.5 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • docosahexaenoic acid
  • docosahexaenoic acid
  • docosahexaenoic acid
  • docosahexaenoic acid
  • efalex
  • fish oil
  • fish oil
  • fish oil triglycerides
  • omegavan
  • omegaven
  • omegaven

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06665464N/ANov 30, 2025Wageningen University
NCT07241377Phase 3Oct 27, 2025RDC Clinical Pty Ltd
NCT07086573N/ASep 22, 2025Nutricia, Utrecht University, Wageningen University
NCT06992726Phase 4Aug 1, 2025Capital Medical University
NCT06629103Phase 4Jan 31, 2025RDC Clinical Pty Ltd
NCT06758778N/AJan 3, 2025SICHUAN CREDIT PHARMACEUTICAL CO., LTD.
NCT06695910Phase 4Nov 6, 2024Institut de recherche clinique du littoral (IRCL), SCF Pharma
NCT06424860Phase 1Oct 1, 2024Heart and Stroke Foundation of Canada, University of Alberta
NCT06531460N/AJul 25, 2024Government of Mexico, Instituto Nacional de Enfermedades Respiratorias
NCT06877494Phase 2Jul 21, 2024Shanghai Eye Disease Prevention and Treatment Center
NCT06492694N/AJun 10, 2024doTERRA
NCT06659068N/AMay 16, 2024Universitas Sriwijaya
NCT06279793Phase 2Feb 15, 2024GCP-Service International Ltd. & Co. KG, Humboldt University, Johannes Gutenburg University, Julius-Maximilians University, Universitaetsklinikum Schleswig-Holstein, University of Augsburg, University of Bonn, University of Goettingen, University of Hamburg, University of Munster
NCT06233825N/AFeb 1, 2024Queen's University, Belfast
NCT06074250Phase 2/Phase 3 (Phase 3)Jan 31, 2024Lotte & John Hecht Memorial Foundation, The Canadian College of Naturopathic Medicine, University of Toronto
NCT06005454N/ASep 1, 2023Cairo University
NCT05971147N/AAug 1, 2023Queen's University, Belfast
NCT05822141N/AJun 12, 2023Indiana University
NCT05869526N/AMay 1, 2023University of Glasgow
NCT05613803Phase 3Jan 31, 2023University of East Anglia
Showing 20 of 390 trials
Page 1 / 20

Organizations

Research & Development (379)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Harvard UniversityAcademic/Hospital322652004
National Center for Complementary and Integrative Health (NCCIH)Government13542003
National Heart, Lung, and Blood Institute (NHLBI)Government12352006
DSMFor profit10342003
Vanderbilt UniversityAcademic/Hospital9832007
University of CincinnatiAcademic/Hospital8532007
University of CopenhagenAcademic/Hospital8732008
University of KansasAcademic/Hospital7732006
Canadian Institutes of Health Research (CIHR)Academic/Hospital6042009
Oregon Health and Science UniversityAcademic/Hospital6432004
UnileverFor profit6312009
United States Department of AgricultureGovernment6422001
Government of MexicoGovernment5542009
National Cancer Institute (NCI)Government5142010
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government5132005
National Institutes of Health (NIH)Government5031989
NestleFor profit5411995
Ohio State UniversityAcademic/Hospital5232007
University of AlbertaAcademic/Hospital5332005
University of California, DavisAcademic/Hospital5222006
379 organizations
Page 1 / 19

Marketing (2)

OrganizationOrg typeRelationshipDate
FreseniusFor profitNDA2Jul 27, 2018
FreseniusFor profitNDAJul 13, 2016