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
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| clariscan | ANDA | 2024-09-17 |
| dotarem | New Drug Application | 2025-03-14 |
| gadoterate meglumine | ANDA | 2024-10-27 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
Code | Description |
|---|---|
| A9575 | Injection, gadoterate meglumine, 0.1 ml |
Clinical
Clinical Trials
50 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast diseases | D001941 | — | N60-N65 | 1 | — | — | 1 | — | 2 |
| Magnetic resonance imaging | D008279 | — | — | — | — | — | 1 | 1 | 2 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 1 | 1 | 2 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 2 | — | 2 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | 1 | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | 1 | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | 1 | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 1 | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | 1 | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral arterial diseases | D002539 | EFO_1000859 | — | — | — | 2 | — | — | 2 |
| Central nervous system diseases | D002493 | — | G96.9 | — | — | 1 | — | — | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | 1 | — | — | 1 |
| Self-assessment | D012647 | — | — | — | — | 1 | — | — | 1 |
| Diagnostic self evaluation | D059026 | — | — | — | — | 1 | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | — | 1 | — | — | 1 |
| Renal artery obstruction | D012078 | EFO_1001150 | N28.0 | — | — | 1 | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Fibroadenoma | D018226 | — | — | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial perfusion imaging | D055414 | — | — | — | — | — | — | 1 | 1 |
| Brain diseases | D001927 | — | G93.40 | — | — | — | — | 1 | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 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.
|
| 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 | — |
Target
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Variants
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Financial
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Trends
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Additional graphs summarizing 2,763 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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3,149 adverse events reported
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