gadoteridol

Trade name: prohance

Small moleculeapproved

Approved

Nov 16, 1992

Gadoteridol (INN) is a gadolinium-based MRI contrast agent, used particularly in the imaging of the central nervous system. It is sold under the brand name ProHance. Gadoteridol is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment produced by the paramagnetic agent results in a relatively large local magnetic field, which can enhance the relaxation rates of water protons in the vicinity of the paramagnetic agent. In magnetic resonance imaging (MRI), visualization of normal and pathologic brain tissue depends in part on variations in the radiofrequency signal intensity that occur with 1) differences in proton density; 2) differences of the spin-lattice or longitudinal relaxation times (T1); and 3) differences in the spin-spin or transverse relaxation time (T2). When placed in a magnetic field, gadoteridol decreases T1 relaxation times in the target tissues. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences. Gadoteridol does not cross the intact blood-brain barrier and, therefore, does not accumulate in normal brain or in lesions that have a normal blood-brain barrier, e.g., cysts, mature post-operative scars, etc. However, disruption of the blood-brain barrier or abnormal vascularity allows accumulation of gadoteridol in lesions such as neoplasms, abscesses, and subacute infarcts. The pharmacokinetics of ProHance in various lesions is not known. — NCATS

Clinical trial activity

10 trials · 11 clinical orgs · 2 marketing orgs

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

Earliest trial started Aug 1, 2007 (NCT00522951)

Timeline

1990s

  1. Nov 16, 1992

    Bracco — Earliest FDA Approval

  2. Nov 16, 1992

    Bracco — NDA Secondary Org

  3. Nov 16, 1992

    Bracco — NDA Organization

2000s

  1. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Jan 1, 2020

    Earliest Phase 1 Sponsor(trial)

  2. Feb 11, 2025

    Hainan Poly Pharm — Marketing Organization

Indications

Mechanism of action

  • Unspecified targetOTHER

    Diagnostic agent

  • contrast mediumRadiopaque

    contrast medium radiopaque

Approval history

  • approvedNov 16, 1992

Chemistry & pharmacology

Loading structure…

SMILES

[Gd+3].CC(O)CN1CCN(CC([O-])=O)CCN(CC([O-])=O)CCN(CC([O-])=O)CC1
Mol. weight
558.68 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

  • gadolinium 1,4,7-tris(carboxymethyl)-10-(2'-hydroxypropyl)-1,4,7,10-tetraazacyclododecane
  • gadolinium 1,4,7-triscarboxymethyl-1,4,7,10-tetraazacyclododecane
  • gadolinium 2,2',2''-[10-(2-hydroxypropyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triyl]triacetate
  • gadolinium 2,2',2''-[10-(2-hydroxypropyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triyl]triacetate
  • gadolinium hp-do3a
  • gadolinium-hp-do3a
  • gadolinium-hp-do3a
  • gadolinium-hp-do 3a
  • gadoteridol
  • gadoteridol
  • gadoteridol
  • gadoteridol
  • gadoteridol
  • gadoteridol
  • gadoteridol
  • gadoteridol
  • gadoteridol
  • gadoteridolum
  • gadoteridolum
  • gd(do3a)
  • gd-hp-d03a
  • gdhpdo3a
  • gd-hpdo3a
  • gd-hpdo3a
  • gd-hpdo3a
  • gd-hp-do3a
  • gd-hp-do 3a
  • gd-hp-do 3a
  • gd-hydroxypropyl-d03a
  • prohance
  • prohance
  • prohance
  • prohance
  • prohance
  • prohance multipack
  • prohance multipack
  • sq 32692
  • sq 32,692
  • sq-32692
  • sq-32692
  • sq-32692

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05915728Phase 3Jul 24, 2023Bayer
NCT05915702Phase 3Jul 24, 2023Bayer
NCT05357833Early Phase 1 (Phase 1)Jun 1, 2022University of Utah
NCT04608812Phase 1Oct 31, 2020Infuseon Therapeutics, Inc., OncoSynergy, Inc.
NCT04373564Phase 4Jul 1, 2020Bayer, Bracco, General Electric, Guerbet, IQVIA
NCT02481882N/AJan 1, 2017University of Nottingham
NCT02359097N/AJan 6, 2015National Cancer Institute (NCI), Oregon Health and Science University
NCT01613417Phase 4Aug 1, 2012Bracco
NCT00709852Phase 3Jun 1, 2008Bayer
NCT00522951Phase 3Aug 1, 2007Bayer
Showing 10 of 10 trials
Page 1 / 1

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BayerFor profit5422007
BraccoFor profit2112012
General ElectricFor profit1012020
GuerbetFor profit1112020
Infuseon Therapeutics, Inc.For profit1012020
IQVIAFor profit1012020
National Cancer Institute (NCI)Government1012015
OncoSynergy, Inc.For profit1112020
Oregon Health and Science UniversityAcademic/Hospital1112015
University of NottinghamAcademic/Hospital1112017
University of UtahAcademic/Hospital1112022
11 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
BraccoFor profitNDA2Nov 16, 1992
BraccoFor profitNDANov 16, 1992
Hainan Poly PharmFor profitMKTGFeb 11, 2025