gadodiamide

Trade name: Omniscan

Small moleculeapproved

Approved

Jan 8, 1993

Gadodiamide is a nonionic, low-osmolar gadolinium-based contrast agent for diagnostic contrast-enhanced magnetic resonance imaging (MRI). — NCATS

Clinical trial activity

6 trials · 11 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
2
Phase 3
2
Phase 4
3

Earliest trial started Sep 1, 2003 (NCT00209391)

Timeline

1990s

  1. Jan 8, 1993

    General Electric — Earliest FDA Approval

  2. Jan 8, 1993

    General Electric — NDA Secondary Org

  3. Jan 8, 1993

    General Electric — NDA Organization

2000s

  1. Jan 1, 2003

    General Electric — Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

  • Unspecified targetOTHER

    Diagnostic agent

  • UnclearUnclear

    Unclear unclear

Approval history

  • approvedJan 8, 1993

Chemistry & pharmacology

Loading structure…

SMILES

[Gd+3].CNC(=O)CN(CCN(CCN(CC([O-])=O)CC(=O)NC)CC([O-])=O)CC([O-])=O
Mol. weight
573.66 g/mol
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • amersham brand of gadodiamide
  • gadodiamide
  • gadodiamide
  • gadodiamide
  • gadodiamide
  • gadodiamide
  • gadodiamide
  • gadodiamide
  • gadodiamide
  • gadodiamide anhydrous
  • gadodiamide anhydrous
  • gadolinium, aqua(5,8-bis(carboxymethyl)-11-(2-(methylamino)-2-oxoethyl)-3-oxo-2,5,8,11-tetraazatridecan-13-oato(3-))-, hydrate
  • gd-dtpa bis-(methylamide)
  • gd-dtpa-bma
  • gddtpa-bma
  • gddtpa-bma
  • nycomed brand of gadodiamide
  • omniscan
  • omniscan
  • omniscan
  • omniscan
  • omniscan
  • omniscan
  • omniscan
  • omniscan unique softpack
  • s-041
  • s-041
  • sanofi winthrop brand of gadodiamide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04776187Phase 4Mar 1, 2021Hengrui Therapeutics, Inc., The Central Hospital of Lishui City
NCT04373564Phase 4Jul 1, 2020Bayer, Bracco, General Electric, Guerbet, IQVIA
NCT02501759N/AMay 1, 2015Medical Research Foundation, Oregon, National Cancer Institute (NCI), Oregon Health and Science University
NCT00908310Phase 4May 1, 2009General Electric, Optum
NCT00209443Phase 3Sep 1, 2004General Electric
NCT00209391Phase 3Sep 1, 2003General Electric
Showing 6 of 6 trials
Page 1 / 1

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
General ElectricFor profit4322003
BayerFor profit1012020
BraccoFor profit1012020
GuerbetFor profit1112020
Hengrui Therapeutics, Inc.For profit1012021
IQVIAFor profit1012020
Medical Research Foundation, OregonAcademic/Hospital1012015
National Cancer Institute (NCI)Government1012015
OptumFor profit1012009
Oregon Health and Science UniversityAcademic/Hospital1112015
The Central Hospital of Lishui CityAcademic/Hospital1112021
11 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
General ElectricFor profitNDA2Jan 8, 1993
General ElectricFor profitNDAJan 8, 1993