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 | 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
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 1 | 1 | 2 | 2 | 2 | 7 |
| Lymphatic metastasis | D008207 | EFO_1001364 | — | 1 | 1 | 1 | 1 | 3 | 6 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | 1 | 1 | 1 | 5 |
| Magnetic resonance imaging | D008279 | — | — | — | — | — | 2 | 3 | 5 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | 2 | 2 | 4 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | 1 | 1 | 1 | 4 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 1 | 2 | 3 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | 1 | 2 | 3 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 2 | 1 | 3 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | 1 | 1 | 1 | — | 2 |
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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 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | 1 | — | 1 | 3 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | 1 | — | 1 | 3 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | 2 | — | — | 2 |
| Central nervous system diseases | D002493 | — | G96.9 | — | — | 2 | — | — | 2 |
| Cerebral arterial diseases | D002539 | EFO_1000859 | — | — | — | 2 | — | — | 2 |
| Rectal neoplasms | D012004 | — | — | — | 1 | 1 | — | — | 2 |
| Aneurysm | D000783 | — | I72.9 | — | 1 | 1 | — | 1 | 2 |
| Body weight | D001835 | EFO_0004338 | — | — | — | 1 | — | — | 1 |
| Prostatectomy | D011468 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Uterine cervical neoplasms | D002583 | — | — | 2 | 2 | — | — | 1 | 3 |
| Fibrosis | D005355 | — | — | — | 1 | — | — | 2 | 3 |
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | — | — | 1 | 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 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | 1 | — | — | 1 | 2 |
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | 1 | 1 | — | — | — | 1 |
| Postoperative pain | D010149 | — | G89.18 | — | 1 | — | — | — | 1 |
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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 |
| Fibroadenoma | D018226 | — | — | 1 | — | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | — | — | — | — | 1 |
| Left ventricular hypertrophy | D017379 | EFO_0003896 | — | 1 | — | — | — | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | 1 | — | — | — | — | 1 |
| Infarction | D007238 | EFO_0009463 | — | 1 | — | — | — | — | 1 |
| Hypertrophy | D006984 | EFO_0002460 | — | 1 | — | — | — | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 2 | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 2 | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | — | — | 2 | 2 |
| Ovarian epithelial carcinoma | D000077216 | — | — | — | — | — | — | 2 | 2 |
| Takotsubo cardiomyopathy | D054549 | EFO_1002000 | I51.81 | — | — | — | — | 1 | 1 |
| Male breast neoplasms | D018567 | — | — | — | — | — | — | 1 | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | — | 1 | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Sclerosis | D012598 | — | — | — | — | — | — | 1 | 1 |
| Myocardial perfusion imaging | D055414 | — | — | — | — | — | — | 1 | 1 |
Show 27 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.
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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) |
Target
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Variants
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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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3,366 adverse events reported
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