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gadoteric acid

Trade name: Dotarem

Small moleculeapprovedImaging agent

Approved

Mar 20, 2013

Gadoteric acid, sold under the brand name Dotarem among others, is a macrocycle-structured gadolinium-based MRI contrast agent (GBCA). It consists of the organic acid DOTA as a chelating agent, and gadolinium (Gd3+), and is used in form of the meglumine salt (gadoterate meglumine). The paramagnetic property of gadoteric acid reduces the T1 relaxation time (and to some extent the T2 and T2* relaxation times) in MRI, which is the source of its clinical utility. Because it has magnetic properties, gadoteric acid develops a magnetic moment when put under a magnetic field, which increases the signal intensity (brightness) of tissues during MRI imaging. — Wikipedia

Clinical trial activity

37 trials · 35 clinical orgs · 5 marketing orgs

Phase 1
7
Phase 2
12
Phase 3
8
Phase 4
15

Earliest trial started Mar 1, 2006 (NCT00447889)

Timeline

2000s

  1. Jan 1, 2009

    Guerbet — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Guerbet — Earliest Phase 1 Sponsor(trial)

  2. Mar 20, 2013

    Guerbet — Earliest FDA Approval

  3. Mar 20, 2013

    Guerbet — NDA Secondary Org

  4. Mar 20, 2013

    Guerbet — NDA Organization

  5. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  6. Nov 1, 2019

    General Electric — Marketing Organization

  7. Nov 1, 2019

    Danaher — Marketing Organization

2020s

  1. Apr 11, 2022

    Hengrui Therapeutics, Inc. — Marketing Organization

  2. Jun 17, 2024

    Hainan Poly Pharm — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Diagnostic agent

  • gadoliniumSupplementation

    gadolinium supplementation

Approval history

  • approvedPriority reviewMar 20, 2013

Chemistry & pharmacology

Mol. weight
753.86 g/mol
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

  • [2,2',2'',2'''-(1,4,7,10-tetraazacyclododecane-1,4,7,10-tetrayl-κ4n1,n4,n7,n10)tetraacetato(3−)]gadolinium
  • [2,2',2'',2'''-(1,4,7,10-tetraazacyclododecane-1,4,7,10-tetrayl-κ4n1,n4,n7,n10)tetraacetato(3−)]gadolinium
  • dota-gd
  • dota-gd
  • dotarem
  • dotarem
  • dotarem
  • dotarem
  • dotarem
  • gadolinate(1-), (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetato(4-)-
  • gadolinium 1,4,7,10-tetraazacyclododecane-n,n',n'',n'''-tetraacetate
  • gadolinium dota
  • gadoterate
  • gadoterate
  • gadoterate
  • gadoterate
  • gadoterate dimeglumine
  • gadoterate meglumine
  • gadoterate meglumine
  • gadoterate meglumine
  • gadoterate meglumine
  • gadoterate meglumine
  • gadoterate sodium
  • gadoteric acid
  • gadoteric acid
  • gadoteric acid
  • gadoteric acid
  • gadoteric acid
  • gd-dota
  • gd-dota
  • gd-dota
  • gd-dota
  • gd-dota meglumine
  • magnescope
  • meglumine gadoterate
  • meglumine gadoterate
  • p-449
  • p-449

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06731738Phase 2Nov 22, 2024IC Targets
NCT06704932Phase 1Nov 20, 2024Sanofi
NCT06600880Phase 1Oct 1, 2024Columbia University
NCT06057168Phase 3Sep 7, 2023Guerbet
NCT05915702Phase 3Jul 24, 2023Bayer
NCT05915728Phase 3Jul 24, 2023Bayer
NCT05417776Phase 2Sep 1, 2022Boehringer Ingelheim, Harvard University
NCT04776187Phase 4Mar 1, 2021Hengrui Therapeutics, Inc., The Central Hospital of Lishui City
NCT04341129Early Phase 1 (Phase 1)Aug 31, 2020Guerbet, University of Chicago
NCT04373564Phase 4Jul 1, 2020Bayer, Bracco, General Electric, Guerbet, IQVIA
NCT03730051Phase 4Jun 30, 2019Boston University
NCT03602339Phase 4Sep 30, 2018Bayer
NCT03091803N/AApr 4, 2017National Cancer Institute (NCI), University of Southern California
NCT02899377Phase 1Nov 18, 2016GlaxoSmithKline, IQVIA
NCT03057561N/AOct 1, 2016Guerbet, Methodist Cancer Center, Houston, Texas, The Methodist Hospital System
NCT02718976Phase 2Mar 1, 2016Aarhus University, AP Moeller Foundation
NCT02529475Phase 4Feb 1, 2016University of Grenoble
NCT02593370Phase 1Oct 1, 2015Aarhus University, AP Moeller Foundation
NCT02431598Phase 4Jun 1, 2015Duke University, University of California, San Diego, University of Wisconsin
NCT02364193N/AMar 1, 2015Eindhoven University of Technology, Maastricht University
Showing 20 of 37 trials
Page 1 / 2

Organizations

Research & Development (35)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GuerbetFor profit171442006
BayerFor profit5422008
Aarhus UniversityAcademic/Hospital2222015
AP Moeller FoundationAcademic/Hospital2022015
BraccoFor profit2112014
IQVIAFor profit2022016
University of ParisAcademic/Hospital2122008
University of WashingtonAcademic/Hospital2022010
Boehringer IngelheimFor profit1012022
Boston UniversityAcademic/Hospital1112019
Columbia UniversityAcademic/Hospital1112024
Duke UniversityAcademic/Hospital1112015
Eindhoven University of TechnologyAcademic/Hospital1012015
Fundação de Amparo à Pesquisa do Estado de São PauloAcademic/Hospital1012012
General ElectricFor profit1012020
GlaxoSmithKlineFor profit1112016
Government of FranceGovernment1012014
Harvard UniversityAcademic/Hospital1112022
Hengrui Therapeutics, Inc.For profit1012021
IC TargetsFor profit1112024
35 organizations
Page 1 / 2

Marketing (6)

OrganizationOrg typeRelationshipDate
DanaherFor profitMKTGNov 1, 2019
General ElectricFor profitMKTGNov 1, 2019
GuerbetFor profitNDA2Mar 20, 2013
GuerbetFor profitNDAMar 20, 2013
Hainan Poly PharmFor profitMKTGJun 17, 2024
Hengrui Therapeutics, Inc.For profitMKTGApr 11, 2022