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 | 2025-04-16 |
Indications
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Agency Specific
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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
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic renal insufficiency | D051436 | — | N18 | 1 | 1 | — | — | 1 | 2 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 1 | — | — | — | 2 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | 1 | 1 | — | — | — | 2 |
| Local anesthesia | D000772 | — | — | 1 | 1 | — | — | — | 2 |
| Postoperative pain | D010149 | — | G89.18 | — | 1 | — | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | — | — | — | 1 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | 1 | — | — | — | 1 |
| Fibrosis | D005355 | — | — | — | 1 | — | — | — | 1 |
| Pulmonary fibrosis | D011658 | — | J84.10 | — | 1 | — | — | — | 1 |
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 | 2 |
| Fibroadenoma | D018226 | — | — | 1 | — | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 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 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | — | 1 |
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 |
| Takotsubo cardiomyopathy | D054549 | EFO_1002000 | I51.81 | — | — | — | — | 1 | 1 |
| Male breast neoplasms | D018567 | — | — | — | — | — | — | 1 | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | — | 1 | 1 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 1 | 1 |
| Myocardial perfusion imaging | D055414 | — | — | — | — | — | — | 1 | 1 |
| Brain diseases | D001927 | — | G93.40 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 1 | 1 |
| Acute kidney injury | D058186 | — | N17 | — | — | — | — | 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 | — |
| 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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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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