Gadoterate meglumine
Dotarem (gadoterate meglumine) is a small molecule pharmaceutical. Gadoterate meglumine was first approved as Dotarem on 2013-03-20.
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Therapeutic Areas
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Trade Name
FDA
EMA
Dotarem (generic drugs available since 2019-11-01)
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 |
|---|---|---|---|---|
| DOTAREM | Guerbet | N-204781 RX | 2013-03-20 | 5 products, RLD, RS |
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
60 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 neoplasms | D001943 | EFO_0003869 | C50 | — | 3 | 1 | 1 | 1 | 6 |
| Magnetic resonance imaging | D008279 | — | — | 2 | 1 | 1 | 4 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | 1 | 1 | 1 | 4 |
| Positron-emission tomography | D049268 | — | — | — | 1 | — | 1 | ||
| Cognition | D003071 | EFO_0003925 | — | — | — | 1 | — | 1 | |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | — | — | 1 | — | 1 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Central nervous system diseases | D002493 | HP_0002011 | G96.9 | — | — | 3 | — | 2 | 5 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | 1 | 2 | — | — | 3 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | 1 | 1 | — | — | 2 | |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 1 | — | — | 1 |
| Intracranial arteriosclerosis | D002537 | EFO_1000860 | I67.2 | — | — | 1 | — | — | 1 |
| Cardiovascular abnormalities | D018376 | EFO_0003848 | — | — | 1 | — | — | 1 | |
| Renal artery obstruction | D012078 | EFO_1001150 | N28.0 | — | — | 1 | — | — | 1 |
| Pathologic constriction | D003251 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | — | 2 | — | — | 2 | 4 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | — | — | 1 | 2 |
| Ductal carcinoma | D044584 | — | 1 | — | — | — | 1 | ||
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | — | — | — | 1 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 1 | — | — | — | 1 |
| Coronary artery disease | D003324 | I25.1 | — | 1 | — | — | — | 1 | |
| Magnetic resonance angiography | D018810 | — | 1 | — | — | — | 1 | ||
| Prostatic neoplasms | D011471 | C61 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | 2 | — | — | — | 1 | 3 | |
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Central nervous system neoplasms | D016543 | — | — | — | — | 3 | 3 | ||
| Meniere disease | D008575 | EFO_0006862 | H81.0 | — | — | — | — | 2 | 2 |
| Renal cell carcinoma | D002292 | — | — | — | — | 1 | 1 | ||
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | — | — | — | 1 | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 1 | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | — | — | 1 | 1 | |
| Medulloblastoma | D008527 | — | — | — | — | 1 | 1 | ||
| Gliosarcoma | D018316 | — | — | — | — | 1 | 1 | ||
| Meningioma | D008579 | EFO_0003098 | D32.9 | — | — | — | — | 1 | 1 |
| Ependymoma | D004806 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | GADOTERATE MEGLUMINE |
| INN | gadoteric acid |
| 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) | O=C([O-])CN1CCN(CC(=O)[O-])CCN(CC(=O)O)CCN(CC(=O)[O-])CC1.[Gd+3] |
Identifiers
| PDB | — |
| CAS-ID | 72573-82-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2219415 |
| ChEBI ID | 73727 |
| PubChem CID | 158536 |
| DrugBank | DB09132 |
| UNII ID | QVF9Y6955W (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Clariscan, Dotarem
Adverse Events
Top Adverse Reactions
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9,857 adverse events reported
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