Gadobutrol
Gadavist, Gadobutrol (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, Gadobutrol
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gadavist | New Drug Application | 2025-03-05 |
| gadobutrol | ANDA | 2025-10-31 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
GADOBUTROL, GADOBUTROL, HENGRUI PHARMA | |||
| 2024-04-29 | CGT | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| A9585 | Injection, gadobutrol, 0.1 ml |
Clinical
Clinical Trials
107 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 | 3 | 9 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 1 | — | 1 |
| Fibrosis | D005355 | — | — | — | — | — | 1 | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | — | — | — | 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 | — | G96.9 | — | 1 | 4 | — | — | 5 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | 2 | — | — | 2 |
| Diagnostic imaging | D003952 | — | — | — | — | 2 | — | — | 2 |
| Coronary disease | D003327 | — | — | — | — | 2 | — | — | 2 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | 2 | — | — | 2 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 2 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 2 | — | — | 2 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 1 | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | 1 | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial perfusion imaging | D055414 | — | — | — | 1 | — | — | — | 1 |
| Brain diseases | D001927 | — | G93.40 | — | 1 | — | — | — | 1 |
| Spinal cord diseases | D013118 | — | G95.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Image enhancement | D007089 | — | — | — | — | — | — | 1 | 1 |
| Magnetic resonance angiography | D018810 | — | — | — | — | — | — | 1 | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
| Dilated cardiomyopathy | D002311 | EFO_0000407 | I42.0 | — | — | — | — | 1 | 1 |
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
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Additional graphs summarizing 5,851 documents
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Safety
Black-box Warning
Black-box warning for: Gadavist, Gadobutrol
Adverse Events
Top Adverse Reactions
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5,355 adverse events reported
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