Gadobutrol
Gadavist, Gadobutrol (gadobutrol) is a small molecule pharmaceutical. Gadobutrol was first approved as Gadavist on 2011-03-14.
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Commercial
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Trade Name
FDA
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Gadavist (generic drugs available since 2022-11-17)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gadavist | New Drug Application | 2022-04-27 |
| gadobutrol | ANDA | 2023-11-07 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
GADOBUTROL, GADOBUTROL, HENGRUI PHARMA | |||
| 2024-04-29 | CGT | ||
Patent Expiration
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HCPCS
Code | Description |
|---|---|
| A9585 | Injection, gadobutrol, 0.1 ml |
Clinical
Clinical Trials
100 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Magnetic resonance imaging | D008279 | — | — | 2 | 1 | 2 | 1 | 4 | 10 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | 1 | 1 | 2 | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 2 | 1 | 2 | 5 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | 1 | 2 | 3 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | 2 | — | 2 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | 1 | — | 1 | — | 2 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | 1 | 1 | 2 |
| Magnetic resonance angiography | D018810 | — | — | — | — | — | 1 | 1 | 2 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | 1 | — | 1 |
| Breast diseases | D001941 | — | N60-N65 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary artery disease | D003324 | — | I25.1 | — | — | 2 | — | 3 | 5 |
| Central nervous system diseases | D002493 | HP_0002011 | G96.9 | — | — | 3 | — | — | 3 |
| Adenocarcinoma | D000230 | — | — | — | 1 | 1 | — | — | 2 |
| Diagnostic imaging | D003952 | — | — | — | — | 2 | — | — | 2 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 1 | — | — | 1 |
| Renal artery obstruction | D012078 | EFO_1001150 | N28.0 | — | — | 1 | — | — | 1 |
| Carotid stenosis | D016893 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | 3 | 4 |
| Prostatic neoplasms | D011471 | — | C61 | — | 2 | — | — | — | 2 |
| Myocardial perfusion imaging | D055414 | — | — | — | 1 | — | — | 1 | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | 1 | 2 |
| Spinal cord diseases | D013118 | HP_0002196 | G95.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | 1 | 2 |
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | 2 | — | — | — | — | 2 |
| Heart failure | D006333 | HP_0001635 | I50 | 1 | — | — | — | 1 | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | — | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | — | 3 | 3 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 3 | 3 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 3 | 3 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 2 | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 2 | 2 |
| Glioma | D005910 | EFO_0000520 | — | — | — | — | — | 2 | 2 |
| Lymphedema | D008209 | HP_0001004 | Q82.0 | — | — | — | — | 2 | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 2 | 2 |
| Radiculopathy | D011843 | — | M54.1 | — | — | — | — | 1 | 1 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Gadobutrol |
| INN | gadobutrol |
| Description | Gadobutrol (INN) (Gd-DO3A-butrol) is a gadolinium-based MRI contrast agent (GBCA).
|
| 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 | 770691-21-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2218860 |
| ChEBI ID | — |
| PubChem CID | 72057 |
| DrugBank | DB06703 |
| UNII ID | 1BJ477IO2L (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,706 documents
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Safety
Black-box Warning
Black-box warning for: Gadavist, Gadobutrol
Adverse Events
Top Adverse Reactions
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4,159 adverse events reported
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