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omega-3 fatty acids

Trade name: Omacor

Botanicalapproved

Approved

Nov 10, 2004

Doconexent (Docosahexaenoic acid, DHA) is an omega-3 fatty acid that is a primary structural component of the human brain, cerebral cortex, skin, and retina. DHA is widely used as a food supplement, and is beleived to support healthy brain development in young childred, prevent cardiovascular disease and cognitive decline during Alzheimer's disease. Most of these claims, however, were not supported by clinical trials. DHA spray is used as a tanner. — NCATS

Clinical trial activity

261 trials · 304 clinical orgs · 26 marketing orgs

Phase 1
20
Phase 2
57
Phase 3
31
Phase 4
20

Earliest trial started Sep 1, 1995 (NCT01422317)

Timeline

1990s

  1. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  3. Nov 10, 2004

    Abbott — Earliest FDA Approval

  4. Nov 10, 2004

    Abbott — NDA Organization

  5. Nov 10, 2004

    Woodward — Marketing Organization

  6. Nov 10, 2004

    SmithKline Beecham — Marketing Organization

  7. Nov 10, 2004

    Woodward — NDA Secondary Org

  8. Nov 10, 2004

    Waylis Therap — Marketing Organization

  9. Jun 12, 2007

    Reliant Pharmaceuticals — NDA Secondary Org

2010s

  1. Apr 7, 2014

    Teva — Marketing Organization

  2. Apr 23, 2014

    Osmotica Pharmaceutical — Marketing Organization

  3. Apr 23, 2014

    Osmotica Pharmaceutical — NDA Secondary Org

  4. Jun 24, 2014

    Par Pharmaceuticals — Marketing Organization

  5. Jun 24, 2014

    ONESOURCE SPECIALTY — Marketing Organization

  6. Sep 30, 2014

    Apotex — Marketing Organization

  7. Nov 27, 2015

    Amneal Pharmaceuticals — Marketing Organization

  8. Sep 19, 2017

    Strides Pharma Science — Marketing Organization

  9. Feb 25, 2019

    Ascent Pharmahealth — Marketing Organization

  10. Feb 25, 2019

    Allergan PLC (2015) — Marketing Organization

  11. Jun 14, 2019

    Zydus Discovery DMCC — Marketing Organization

  12. Jul 10, 2019

    Sofgen Pharmaceuticals — Marketing Organization

  13. Aug 7, 2019

    Chartwell Pharmaceuticals — Marketing Organization

  14. Aug 7, 2019

    Bionpharma Inc — Marketing Organization

2020s

  1. Jan 9, 2020

    Sun Pharmaceuticals — Marketing Organization

  2. May 12, 2020

    Shijiazhuang Pharma Group (CSPC) — Marketing Organization

  3. Jun 15, 2020

    Puracap Pharmaceutical — Marketing Organization

  4. Aug 19, 2020

    GLW Pharma — Marketing Organization

  5. Nov 15, 2021

    MannKind Corp — Marketing Organization

  6. Nov 15, 2021

    Mankind Pharma — Marketing Organization

  7. Dec 7, 2023

    Slayback Pharma Llc — Marketing Organization

  8. Dec 7, 2023

    Wilshire Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

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/C\C=C/CCC(O)=O
Mol. weight
328.4883 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

  • 22:6-4, 7,10,13,16,19
  • 22:6(n-3)
  • 22:6(n-3)
  • 4,7,10,13,16,19-docosahexaenoic acid
  • 4,7,10,13,16,19-docosahexaenoic acid
  • (4z,7z,10z,13z,16z,19z)-docosahexaenoic acid
  • (4z,7z,10z,13z,16z,19z)-docosahexaenoic acid
  • all-cis-dha
  • all-cis-dha
  • cervonic acid
  • cervonic acid
  • cervonic acid
  • dha
  • dha
  • dha
  • doconexent
  • doconexent
  • doconexent
  • doconexent
  • doconexent
  • doconexent (dha ethyl ester)
  • doconexent (dha ethyl ester)
  • docosa-4,7,10,13,16,19-hexaenoic acid
  • docosa-4,7,10,13,16,19-hexaenoic acid
  • docosahexaenoic aci
  • docosahexaenoic acid
  • docosahexaenoic acid
  • docosahexanoic acid
  • doscosahexaenoic acid
  • ir103
  • omega-3acid ethyl esters
  • remune
  • triomar

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07288619N/AOct 15, 2025University of Health Sciences Lahore
NCT07255326N/AOct 1, 2025University of Faisalabad
NCT07134140N/ASep 30, 2025European University Cyprus
NCT07050524Phase 2Sep 1, 2025Nanjing Medical University, Nanjing University, Suzhou Medical College, Xuzhou Medical University
NCT06881966N/ASep 1, 2025Rouen Normandy University
NCT07118059Phase 2Aug 31, 2025North-West University, University of the Witwatersrand
NCT07136519Phase 2Aug 22, 2025Guangdong Medical University
NCT07078344Phase 1Jul 31, 2025Georgetown University, National Center for Complementary and Integrative Health (NCCIH), University of Arizona
NCT06845046N/AJul 15, 2025Department of Veteran Affairs
NCT07048860N/AJul 9, 2025University of Toulouse
NCT07272382N/AJun 5, 2025Fudan University
NCT07289919N/AMay 26, 2025University of Sao Paulo
NCT07162688Phase 1/Phase 2 (Phase 2)May 16, 2025Fujian Medical University
NCT06971445N/AMay 14, 2025Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
NCT07133477N/AApr 30, 2025Epax Norway AS
NCT07036952N/AApr 22, 2025Bangladesh Medical University
NCT06629103Phase 4Jan 31, 2025RDC Clinical Pty Ltd
NCT07054762N/AJan 10, 2025Muğla Sıtkı Koçman University
NCT06749028N/ADec 17, 2024Fundacion del Caribe para la Investigacion Biomedica, Naturmega
NCT06698588N/ANov 7, 2024Swansea University
Showing 20 of 261 trials
Page 1 / 14

Organizations

Research & Development (304)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Applied Science Private University, Amman -JordanAcademic/Hospital8812016
Government of MexicoGovernment8732005
Harvard UniversityAcademic/Hospital7652006
Instituto Mexicano del Seguro SocialGovernment6032005
University of ArizonaAcademic/Hospital6332019
University of ManitobaAcademic/Hospital6412015
Beni Suef UniversityAcademic/Hospital4422019
Cairo UniversityAcademic/Hospital4332015
Canadian Institutes of Health Research (CIHR)Academic/Hospital4122004
NantWorksFor profit4412017
National Institutes of Health (NIH)Government4012009
University of CopenhagenAcademic/Hospital4412011
University of PennsylvaniaAcademic/Hospital4232009
Ain Shams UniversityAcademic/Hospital3322015
Government of SingaporeGovernment3222009
Maternity and Children Hospital, MakkahAcademic/Hospital3012019
Texas Tech UniversityAcademic/Hospital3312019
Universidad Nacional Andres BelloAcademic/Hospital3112016
University of BergenAcademic/Hospital3221995
University of ChicagoAcademic/Hospital3322009
304 organizations
Page 1 / 16

Marketing (32)

OrganizationOrg typeRelationshipDate
AbbottFor profitNDANov 10, 2004
Allergan PLC (2015)For profitMKTGFeb 25, 2019
Amneal PharmaceuticalsFor profitMKTGNov 27, 2015
ApotexFor profitMKTGSep 30, 2014
Ascent PharmahealthFor profitMKTGFeb 25, 2019
Bionpharma IncFor profitMKTGAug 7, 2019
Bionpharma IncFor profitSYNAug 7, 2019
Chartwell PharmaceuticalsFor profitMKTGAug 7, 2019
GLW PharmaFor profitMKTGAug 19, 2020
Mankind PharmaFor profitMKTGNov 15, 2021
MannKind CorpFor profitMKTGNov 15, 2021
ONESOURCE SPECIALTYFor profitMKTGJun 24, 2014
Osmotica PharmaceuticalFor profitSYNApr 23, 2014
Osmotica PharmaceuticalFor profitMKTGApr 23, 2014
Osmotica PharmaceuticalFor profitNDA2Apr 23, 2014
Par PharmaceuticalsFor profitMKTGJun 24, 2014
Puracap PharmaceuticalFor profitMKTGJun 15, 2020
Reliant PharmaceuticalsFor profitNDA2Jun 12, 2007
Shijiazhuang Pharma Group (CSPC)For profitMKTGMay 12, 2020
Shijiazhuang Pharma Group (CSPC)For profitSYNMay 12, 2020
Slayback Pharma LlcFor profitMKTGDec 7, 2023
SmithKline BeechamFor profitMKTGNov 10, 2004
Sofgen PharmaceuticalsFor profitMKTGJul 10, 2019
Strides Pharma ScienceFor profitMKTGSep 19, 2017
Sun PharmaceuticalsFor profitMKTGJan 9, 2020
TevaFor profitMKTGApr 7, 2014
Waylis TherapFor profitMKTGNov 10, 2004
Wilshire PharmaceuticalsFor profitMKTGDec 7, 2023
WoodwardFor profitMKTGNov 10, 2004
WoodwardFor profitNDA2Nov 10, 2004
Zydus Discovery DMCCFor profitSYNJun 14, 2019
Zydus Discovery DMCCFor profitMKTGJun 14, 2019