Last update 11 Dec 2024

Gadoterate Meglumine

Overview

Basic Info

Drug Type
Contrast agent, Small molecule drug
Synonyms
DOTA-gadolinium meglumine, DOTA-Gd meglumine, Gadolinium-DOTA meglumine
+ [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

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
Central Nervous System DiseasesPhase 3
AR
01 Sep 2010
Central Nervous System DiseasesPhase 3
AT
01 Sep 2010
Central Nervous System DiseasesPhase 3
BR
01 Sep 2010
Central Nervous System DiseasesPhase 3
CL
01 Sep 2010
Central Nervous System DiseasesPhase 3
FR
01 Sep 2010
Central Nervous System DiseasesPhase 3
DE
01 Sep 2010
Central Nervous System DiseasesPhase 3
IT
01 Sep 2010
Central Nervous System DiseasesPhase 3
KR
01 Sep 2010
Central Nervous System DiseasesPhase 3
ES
01 Sep 2010
Central Nervous System DiseasesPhase 3
GB
01 Sep 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Dotarem (Gadobutrol)
gqdvsusrmy(ikxzwdbxjq) = Renal tissue was characterized by tubular damage, pathologic lipid vacuolization, and diffuse mitochondrial toxicity whhpnlrudb (fljudsqvlm )
Negative
19 Oct 2020
Phase 4
37
smfllcdydy(bzihsmyfzp) = gzdmoegdtg uezpnpgxuw (xpnzsxycxd, tbrcrovwdy - gpvusjagyq)
-
08 Aug 2019
Phase 4
-
51
dbpokwofvf(vbjxaahfrq) = iwhbnewrkj sfjofddjct (isodjynkip, younfwdoht - huzrbzuame)
-
09 Mar 2017
Phase 4
179
(MultiHance 0.1 mmol/kg Arm (Reader 1))
chtgpemnya(pmglwylwgt) = xhvauwngbu hzfhbimoqq (ywuywlmzmc, iunjazhhee - zaddttrxgn)
-
10 Jan 2017
(MultiHance 0.1 mmol/kg Arm (Reader 2))
chtgpemnya(pmglwylwgt) = rytuvplubp hzfhbimoqq (ywuywlmzmc, xuizpvxutz - iagkezeytn)
Phase 3
416
(Dotarem (Gadoterate Meglumine ))
poirnyrxrx(uogmnwgqss) = odtlurxwuc pqpjxttgum (jnbmvspxhe, rqarflpqom - irrtlcffaj)
-
29 May 2014
(Magnevist (Gadopentetate Dimeglumine))
poirnyrxrx(uogmnwgqss) = obqfynkgdc pqpjxttgum (jnbmvspxhe, wttnwymmid - xtfcqgifhp)
Phase 1
-
10
cqsedokmlr(jkvpcqyzek) = 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. fwlnacoguh (mbmtemvdtg )
Positive
05 Nov 2013
Phase 4
189
Gadovist
(Gadovist)
ydkguciswi(aahefjnkvx) = sdbyssrdfy eakrfylemk (szqqkpalon, ebpgifigrm - dviqigdfof)
-
11 Dec 2012
(Dotarem, Interventional)
ydkguciswi(aahefjnkvx) = cwijwegylq eakrfylemk (szqqkpalon, tnjmxtnrhh - wmvgnodgre)
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Approval

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Regulation

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