Last update 23 Jan 2025

Gadoterate Meglumine

Overview

Basic Info

Drug Type
Contrast agent, Small molecule drug
Synonyms
DOTA-Gd meglumine, DOTA-gadolinium meglumine, GD-DOTA
+ [16]
Target-
Mechanism
Magnetic resonance imaging enhancers
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
JP (22 Sep 2000),
Regulation-
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Structure/Sequence

Molecular FormulaC23H42GdN5O13
InChIKeyRYHQMKVRYNEBNJ-BMWGJIJESA-K
CAS Registry92943-93-6

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Vascular Diseases
US
20 Mar 2013
Contrast agents
JP
22 Sep 2000
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Renal Artery ObstructionPhase 1
US
01 Apr 2009
vascular arterial diseasePhase 1
US
01 Apr 2009
Central Nervous System DiseasesPreclinical
GB
01 Sep 2010
Central Nervous System DiseasesPreclinical
KR
01 Sep 2010
Central Nervous System DiseasesPreclinical
DE
01 Sep 2010
Central Nervous System DiseasesPreclinical
CL
01 Sep 2010
Central Nervous System DiseasesPreclinical
IT
01 Sep 2010
Central Nervous System DiseasesPreclinical
AR
01 Sep 2010
Central Nervous System DiseasesPreclinical
FR
01 Sep 2010
Cerebral Arterial DiseasesPreclinical
US
01 Oct 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
37
gnonkmbwcp(upqtgepeqd) = ajqkvjfdjf vgufifmkth (ruxkdmjgjd, kszozdsodc - kewscsoqki)
-
08 Aug 2019
Phase 4
-
51
bcoectuvuh(mewwncqxbq) = adkizgckuq xxidrbwvjw (cmouharbuy, wxxbiezylc - ieiyiwklpv)
-
09 Mar 2017
Phase 4
179
(MultiHance 0.1 mmol/kg Arm (Reader 1))
dxpmdqferm(ikqlxginkj) = dooypgyhax efnxrfkcpv (zylumsbsjn, rtnyevzqlf - zhiyiqughk)
-
10 Jan 2017
(MultiHance 0.1 mmol/kg Arm (Reader 2))
dxpmdqferm(ikqlxginkj) = agipdicvzc efnxrfkcpv (zylumsbsjn, cwzcdkoxix - jlaghcejfg)
Phase 3
416
(Dotarem (Gadoterate Meglumine ))
bnfmujtdmd(sheutmbyav) = qdvocrzybk ugoidzsryt (aylxylsrxe, ymwbakvwta - zsvsbjrsyl)
-
29 May 2014
(Magnevist (Gadopentetate Dimeglumine))
bnfmujtdmd(sheutmbyav) = efmictmpvy ugoidzsryt (aylxylsrxe, cdamalnljv - xdhkcjvgxd)
Phase 1
-
10
oseniybdfd(oqdsgqttfd) = No Aes related to gadoterate were reported. No Aes occurred at the injection site during the observation period. There were no clinically relevant changes in mean laboratory values and vital signs. No cases of Nephrogenic Systemic Fibrosis have been reported so far. kpqescqsyk (aozmdlmwdb )
Positive
05 Nov 2013
Phase 4
189
Gadovist
(Gadovist)
yokckblgrj(gzykgpkpap) = adihglnilm gpnvmctqgg (mbnhlxwuua, ylejbstcdj - bthblvjsrh)
-
11 Dec 2012
(Dotarem, Interventional)
yokckblgrj(gzykgpkpap) = djhbkmnsxj gpnvmctqgg (mbnhlxwuua, kxenpxjzij - nxfssrnwqj)
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Approval

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Regulation

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