Gadobutrol
Gadavist (gadobutrol) is a small molecule pharmaceutical. Gadobutrol was first approved as Gadavist on 2011-03-14.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Gadavist (generic drugs available since 2022-11-17)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gadobutrol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GADAVIST | Bayer | N-201277 RX | 2011-03-14 | 6 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gadavist | New Drug Application | 2021-08-30 |
| gadobutrol | ANDA | 2023-03-15 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| A9585 | Injection, gadobutrol, 0.1 ml |
Clinical
Clinical Trials
59 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 | GADOBUTROL |
| INN | gadobutrol |
| Description | Gadobutrol is a gadolinium coordination entity consisting of a central Gd(III) atom bound to a macrocyclic tetraamine framework. It is used as a paramagnetic contrast agent in magnetic resonance imaging (MRI). It has a role as a MRI contrast agent. |
| 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 | 84990 |
| ChEMBL ID | CHEMBL2218860 |
| ChEBI ID | — |
| PubChem CID | 70678987 |
| DrugBank | DB06703 |
| UNII ID | 1BJ477IO2L (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
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Variants
Clinical Variant
No data
Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,250 documents
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Safety
Black-box Warning
Black-box warning for: Gadavist, Gadobutrol
Adverse Events
Top Adverse Reactions
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5,466 adverse events reported
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