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
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Trade Name
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Clariscan, Dotarem, Gadoterate meglumine
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| clariscan | ANDA | 2025-05-19 |
| dotarem | New Drug Application | 2025-03-14 |
| gadoterate meglumine | ANDA | 2025-04-16 |
Indications
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Agency Specific
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HCPCS
Code | Description |
|---|---|
| A9575 | Injection, gadoterate meglumine, 0.1 ml |
Clinical
Clinical Trials
84 clinical trials
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Indications Phases 4
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 1 | 1 |
| Left ventricular dysfunction | D018487 | — | — | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Myocarditis | D009205 | — | I51.4 | — | — | — | — | 1 | 1 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | — | — | 1 | 1 |
| Ventricular dysfunction | D018754 | — | — | — | — | — | — | 1 | 1 |
| Magnetic resonance imaging | D008279 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Gadoterate 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.
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| Classification | Small molecule |
| Drug class | gadolinium derivatives (principally for diagnostic use) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 72573-82-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2219415 |
| ChEBI ID | 73727 |
| PubChem CID | 158536 |
| DrugBank | DB09132 |
| UNII ID | L0ND3981AG (ChemIDplus, GSRS) |
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Additional graphs summarizing 6,104 documents
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Safety
Black-box Warning
Black-box warning for: Clariscan, Dotarem, Gadoterate meglumine
Adverse Events
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3,366 adverse events reported
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