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soybean oil

Trade name: Intralipid

Botanicalapproved

Approved

Oct 7, 1975

Soybean oil is a vegetable oil extracted from soybean legumes. It is one of the most widely consumed cooking oils and the second most consumed vegetable oil. As a drying oil, processed soybean oil is also used as a base for printing inks and oil paints. — Wikipedia

Clinical trial activity

109 trials · 112 clinical orgs · 6 marketing orgs

Phase 1
11
Phase 2
25
Phase 3
20
Phase 4
23

Earliest trial started Mar 1, 2003 (NCT00892684)

Timeline

1970s

  1. Oct 7, 1975

    Fresenius — Earliest FDA Approval

  2. Oct 7, 1975

    Fresenius — NDA Secondary Org

  3. Oct 7, 1975

    Fresenius — NDA Organization

1980s

  1. Feb 26, 1982

    Baxter — NDA Secondary Org

  2. Jun 29, 1983

    Alpha Therapeutic Corporation — NDA Secondary Org

  3. Aug 27, 1984

    Hospira — NDA Secondary Org

  4. Aug 19, 1985

    Baxalta — NDA Secondary Org

1990s

  1. May 28, 1993

    B. Braun — NDA Secondary Org

2000s

  1. Jan 1, 2006

    B. Braun — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2008

    B. Braun — Earliest Phase 3 Sponsor(trial)

2010s

  1. Oct 3, 2013

    Baxalta — Marketing Organization

  2. Aug 25, 2014

    Fresenius — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedOct 7, 1975

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • intrafat
  • intralipid
  • intralipid
  • intralipid
  • intralipid
  • lipofundin
  • lipofundin
  • liposyn iii
  • liposyn iii
  • liposyn iii
  • nutrilipid
  • soyacal
  • soy bean oil
  • soybean oil
  • soybean oil
  • soybean oil
  • soybean oil
  • soybean oil, phospholipid emulsion
  • travamulsion
  • travamulsion
  • travamulsion

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06736925Phase 2Jan 31, 2025Indiana University, National Institute of Neurological Disorders and Stroke (NINDS)
NCT06625372N/AOct 12, 2024Shahid Beheshti University of Medical Sciences
NCT05553405Phase 1Jan 1, 2023Yale University
NCT05199948N/AMay 2, 2022Ohio State University
NCT04832009Early Phase 1 (Phase 1)Jan 1, 2022University of Kansas
NCT04975763N/AJul 19, 2021Ohio State University
NCT04807634N/AMar 10, 2021Ain Shams University
NCT04466618Phase 3Dec 31, 2020Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT04555044Phase 4Nov 19, 2020Baxalta
NCT04584983Phase 2Nov 1, 2020University of Texas at Houston
NCT04806425Phase 4Oct 1, 2020Ain Shams University
NCT04558190N/ASep 2, 2020University of Copenhagen
NCT04328337Phase 1/Phase 2 (Phase 2)Jul 1, 2020Yale University
NCT04393103Phase 2/Phase 3 (Phase 3)May 31, 2020Assiut University
NCT04274803Phase 4Apr 1, 2020Tanta University
NCT04120220N/ANov 30, 2019United States Department of Agriculture
NCT04242004Phase 1/Phase 2 (Phase 2)Oct 30, 2019Fudan University
NCT03998709Phase 4Oct 1, 2019Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT04084522N/ASep 30, 2019Institute of Liver and Biliary Sciences, India
NCT04067323N/ASep 8, 2019National Institute of Nutrition, Vietnam
Showing 20 of 109 trials
Page 1 / 6

Organizations

Research & Development (112)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Emory UniversityAcademic/Hospital6632004
Ain Shams UniversityAcademic/Hospital5442012
Harvard UniversityAcademic/Hospital5432006
University of TorontoAcademic/Hospital5542004
BaxaltaFor profit4222008
B. BraunFor profit4432006
FreseniusFor profit4232009
Mayo ClinicAcademic/Hospital4432018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government4032008
Assiut UniversityAcademic/Hospital3322012
Cairo UniversityAcademic/Hospital3222012
American Diabetes AssociationAcademic/Hospital2012004
Indiana UniversityAcademic/Hospital2222018
Institute of Liver and Biliary Sciences, IndiaAcademic/Hospital2212016
Jiao Tong UniversityAcademic/Hospital2212012
National Center for Complementary and Integrative Health (NCCIH)Government2022008
Office of Dietary Supplements (ODS)Government2022008
Ohio State UniversityAcademic/Hospital2212021
Radboud UniversityAcademic/Hospital2222005
United States Department of AgricultureGovernment2212015
112 organizations
Page 1 / 6

Marketing (9)

OrganizationOrg typeRelationshipDate
Alpha Therapeutic CorporationFor profitNDA2Jun 29, 1983
B. BraunFor profitNDA2May 28, 1993
BaxaltaFor profitMKTGOct 3, 2013
BaxaltaFor profitNDA2Aug 19, 1985
BaxterFor profitNDA2Feb 26, 1982
FreseniusFor profitMKTGAug 25, 2014
FreseniusFor profitNDA2Oct 7, 1975
FreseniusFor profitNDAOct 7, 1975
HospiraFor profitNDA2Aug 27, 1984