iodixanol

Trade name: visipaque

Small moleculeapproved

Approved

Mar 22, 1996

Iodixanol (brand name VISIPAQUE) is an iodine-containing nonionic dimeric hydrophilic contrast agent for intravascular (intravenous and intra-arterial) use during coronary angiography. Pharmacodynamics studies indicated that iodixanol had fewer cardiovascular effects, caused less renal damage and were associated with similar or smaller changes to the blood-brain barrier and neurological function when compared with nonionic contrast media. It is known, that the organic iodine compounds attenuate x-rays as they pass through the body, thereby allowing the body structures containing iodine to be delineated in contrast to those structures that do not contain iodine. The degree of opacity produced by these compounds is directly proportional to the total amount (concentration and volume) of the iodinated contrast agent in the path of the x-rays. Thus, after intravascular administration, iodixanol makes opaque those internal structures in its path of flow, allowing their visualization until significant hemodilution and elimination occur. — NCATS

Clinical trial activity

42 trials · 39 clinical orgs · 2 marketing orgs

Phase 1
5
Phase 2
6
Phase 3
4
Phase 4
28

Earliest trial started Jan 1, 2004 (NCT00247325)

Timeline

1990s

  1. Mar 22, 1996

    General Electric — Earliest FDA Approval

  2. Mar 22, 1996

    General Electric — NDA Secondary Org

  3. Mar 22, 1996

    General Electric — NDA Organization

2000s

  1. Jan 1, 2006

    General Electric — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2009

    General Electric — Earliest Phase 1 Sponsor(trial)

2020s

  1. May 19, 2022

    Hengrui Therapeutics, Inc. — Marketing Organization

Indications

Mechanism of action

  • Unspecified targetOTHER

    Diagnostic agent

  • contrast mediumRadiopaque

    contrast medium radiopaque

Approval history

  • approvedMar 22, 1996

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)N(CC(O)CN(C(C)=O)C1=C(I)C(C(=O)NCC(O)CO)=C(I)C(C(=O)NCC(O)CO)=C1I)C2=C(I)C(C(=O)NCC(O)CO)=C(I)C(C(=O)NCC(O)CO)=C2I
Mol. weight
1550.1819 g/mol
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 1,3-benzenedicarboxamide, 5,5'-((2-hydroxy-1,3-propanediyl)bis(acetylimino))bis(n,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo)-, (16alpha)-
  • 2-541o-3a
  • 2-541o-3a
  • 5,5'-((2-hydroxytrimethylene)bis(acetylimino))bis(n,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide)
  • 5,5'-((2-hydroxytrimethylene)bis(acetylimino))bis(n,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide)
  • contrast media 2-5410-3
  • indixanol
  • indixanol
  • iodixanol
  • iodixanol
  • iodixanol
  • iodixanol
  • iodixanol
  • iodixanol
  • iodixanol
  • iodixanol
  • iodixanol
  • iodixanol
  • iodixanol-320
  • iodixanolum
  • iodixanolum
  • nasapaque
  • pegylated liposomal iodixanol
  • visiopaque
  • visipaque
  • visipaque
  • visipaque
  • visipaque
  • visipaque
  • visipaque
  • visipaque
  • visipaque 270
  • visipaque 270
  • visipaque 320
  • visipaque 320
  • visipaque 320
  • visipaque unique softpac

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05490381Phase 1Jan 5, 2023Guerbet, University of Washington
NCT05065073Phase 4Sep 30, 2021Minneapolis Heart Institute
NCT03631771Phase 4Feb 28, 2019Bayer, Duke University, General Electric
NCT03119662Phase 4Jun 1, 2017General Electric, INC Research
NCT02718521N/AMar 1, 2016People's Liberation Army of China
NCT01935141N/AJan 1, 2016Department of Veteran Affairs
NCT02377895Phase 1/Phase 2 (Phase 2)Mar 1, 20153E Therapeutics Corporation, ORA, Inc.
NCT02063594Phase 1Mar 1, 2014IQVIA, Marval Pharma Ltd.
NCT02405377N/AFeb 1, 2014People's Liberation Army of China
NCT01908309Early Phase 1 (Phase 1)Apr 1, 2013Azienda Sanitaria Locale 9, Grosseto
NCT01843426N/AFeb 1, 2013General Electric, Medical University of South Carolina, University of South Carolina
NCT01848899Phase 4Feb 1, 2013Guerbet, New York University
NCT03333330Phase 3Apr 30, 2012University of Milan, Vita-Salute University of Milano. Italy
NCT01580046Phase 4Apr 1, 2012Peking University
NCT01475097Phase 4Oct 1, 2011General Electric, Optum
NCT01376089Phase 4May 1, 2011General Electric, Optum
NCT01137786Phase 4Dec 1, 2010Bracco
NCT01136876Phase 4Nov 1, 2010Bracco
NCT01136915Phase 4Nov 1, 2010Bracco
NCT01075217Phase 4Apr 1, 2010Bracco
Showing 20 of 42 trials
Page 1 / 3

Organizations

Research & Development (39)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
General ElectricFor profit131142005
BraccoFor profit6612008
People's Liberation Army of ChinaGovernment4322008
GuerbetFor profit3122006
OptumFor profit3022009
Department of Veteran AffairsGovernment2222008
Duke UniversityAcademic/Hospital2122008
IQVIAFor profit2022005
Seoul National UniversityAcademic/Hospital2212004
University of MilanAcademic/Hospital2122008
3E Therapeutics CorporationFor profit1112015
ABX-CROFor profit1012005
Aptiv SolutionsFor profit1012005
Azienda Sanitaria Locale 9, GrossetoGovernment1112013
BayerFor profit1012019
CovanceFor profit1012005
Examination Management Services Inc.For profit1012005
INC ResearchFor profit1012017
MallinckrodtFor profit1112009
Marval Pharma Ltd.For profit1112014
39 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
General ElectricFor profitNDA2Mar 22, 1996
General ElectricFor profitNDAMar 22, 1996
Hengrui Therapeutics, Inc.For profitMKTGMay 19, 2022