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Drug ReportsGadoterate meglumine
Gadoterate meglumine
Clariscan, Dotarem, Gadoterate Meglumine (gadoterate meglumine) is a small molecule pharmaceutical. Gadoterate meglumine was first approved as Dotarem on 2013-03-20.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Clariscan, Dotarem, Gadoterate meglumine
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gadoterate meglumine
Tradename
Company
Number
Date
Products
DOTAREMGuerbetN-204781 RX2013-03-20
5 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
clariscanANDA2024-09-17
dotaremNew Drug Application2025-03-14
gadoterate meglumineANDA2025-04-16
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
V: Various drug classes in atc
V08: Contrast media
V08C: Magnetic resonance imaging contrast media
V08CA: Paramagnetic contrast media
V08CA02: Gadoteric acid
HCPCS
Code
Description
A9575
Injection, gadoterate meglumine, 0.1 ml
Clinical
Clinical Trials
81 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C61112126
Lymphatic metastasisD008207EFO_1001364111136
Magnetic resonance imagingD008279235
Brain neoplasmsD001932EFO_0003833C7111114
Renal insufficiencyD051437N1911214
Hepatocellular carcinomaD006528C22.0123
Liver neoplasmsD008113EFO_1001513C22.0123
Peripheral arterial diseaseD058729EFO_000426522
Peripheral vascular diseasesD016491EFO_0003875I73.922
Breast diseasesD001941N60-N65112
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Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Uterine cervical neoplasmsD0025832213
InflammationD007249MP_0001845112
CarcinomaD002277C80.01112
Squamous cell carcinoma of head and neckD0000771951112
Chronic renal insufficiencyD051436N181112
Hip fracturesD006620EFO_0003964S72.00112
Local anesthesiaD000772112
Endometrial neoplasmsD016889EFO_00042301112
FibrosisD005355112
Uterine neoplasmsD014594EFO_0003859C55111
Show 13 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G35112
SclerosisD012598112
FibroadenomaD01822611
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.911
Heart failureD006333EFO_0003144I5011
Left ventricular hypertrophyD017379EFO_000389611
Myocardial infarctionD009203EFO_0000612I2111
InfarctionD007238EFO_000946311
HypertrophyD006984EFO_000246011
PainD010146EFO_0003843R5211
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Indications Without Phase
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGadoterate meglumine
INN_
Description
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.
Classification
Small molecule
Drug classgadolinium derivatives (principally for diagnostic use)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID72573-82-1
RxCUI
ChEMBL IDCHEMBL2219415
ChEBI ID73727
PubChem CID158536
DrugBankDB09132
UNII IDL0ND3981AG (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,869 documents
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Safety
Black-box Warning
Black-box warning for: Clariscan, Dotarem, Gadoterate meglumine
Adverse Events
Top Adverse Reactions
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3,307 adverse events reported
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