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
FDA
EMA
Dotarem (generic drugs available since 2019-11-01)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| clariscan | ANDA | 2024-01-11 |
| dotarem | New Drug Application | 2022-04-27 |
| gadoterate meglumine | ANDA | 2022-06-09 |
Indications
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EMA
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Agency Specific
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HCPCS
Code | Description |
|---|---|
| A9575 | Injection, gadoterate meglumine, 0.1 ml |
Clinical
Clinical Trials
77 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 neoplasms | D011471 | — | C61 | 1 | 1 | 2 | 1 | 2 | 6 |
| Magnetic resonance imaging | D008279 | — | — | — | — | — | 2 | 3 | 5 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | 1 | 1 | 3 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | 2 | — | 2 |
| Breast diseases | D001941 | — | N60-N65 | 1 | — | — | 1 | — | 2 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | 1 | 1 | 2 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | 1 | 1 | 2 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | — | — | 1 | 1 | 2 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 1 | 1 | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | 1 | 1 | 2 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 1 | 1 | — | 1 | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | 1 | — | — | 3 |
| Cerebral arterial diseases | D002539 | EFO_1000859 | — | — | — | 2 | — | — | 2 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | 1 | 1 | — | — | 1 |
| Prostatectomy | D011468 | — | — | — | — | 1 | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | 1 | — | — | 1 |
| Central nervous system diseases | D002493 | HP_0002011 | G96.9 | — | — | 1 | — | — | 1 |
| Diagnostic self evaluation | D059026 | — | — | — | — | 1 | — | — | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | 1 | — | — | 1 |
| Renal artery obstruction | D012078 | EFO_1001150 | N28.0 | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | 2 | 2 | — | — | — | 2 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | 1 | — | — | 1 | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | 1 | — | — | 1 | 2 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | 1 | 1 | — | — | — | 2 |
| Local anesthesia | D000772 | — | — | 1 | 1 | — | — | — | 2 |
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | 1 | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | — | — | 1 |
| Postoperative pain | D010149 | — | G89.18 | — | 1 | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | 1 | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | 1 | — | — | — | 1 |
Show 2 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | — | — | — | 1 | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | 1 | — | — | — | — | 1 |
| Left ventricular hypertrophy | D017379 | EFO_0003896 | — | 1 | — | — | — | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | 1 | — | — | — | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 2 | 2 |
| Takotsubo cardiomyopathy | D054549 | EFO_1002000 | I51.81 | — | — | — | — | 1 | 1 |
| Male breast neoplasms | D018567 | — | — | — | — | — | — | 1 | 1 |
| Autoimmune diseases | D001327 | HP_0002960 | M30-M36 | — | — | — | — | 1 | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
| Myocardial perfusion imaging | D055414 | — | — | — | — | — | — | 1 | 1 |
| 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 |
Show 19 more
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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Trends
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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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2,298 adverse events reported
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