Gadoteridol
Prohance (gadoteridol) is a small molecule pharmaceutical. Gadoteridol was first approved as Prohance on 1992-11-16.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Prohance, Prohance multipack
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gadoteridol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROHANCE | Bracco Diagnostics | N-020131 RX | 1992-11-16 | 1 products, RLD, RS |
| PROHANCE MULTIPACK | Bracco Diagnostics | N-021489 RX | 2003-10-09 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| prohance | New Drug Application | 2024-09-04 |
| prohance multipack | 2006-04-13 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| A9576 | Injection, gadoteridol, (prohance multipack), per ml |
Clinical
Clinical Trials
21 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cognition | D003071 | EFO_0003925 | — | — | — | — | 1 | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | 1 | — | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 1 | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | 1 | — | 1 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | — | — | 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 | — | — | 2 | — | 1 | 3 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | 1 | — | 1 | 3 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | 1 | — | 1 | 2 |
| Diagnostic imaging | D003952 | — | — | — | — | 1 | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | 1 | — | — | 2 | 4 |
| Sclerosis | D012598 | — | — | 1 | 1 | — | — | 2 | 4 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | 2 | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | — | — | — | — | 1 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 2 | 2 |
| Thrombosis | D013927 | — | — | — | — | — | — | 2 | 2 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 2 | 2 |
| Dilated cardiomyopathy | D002311 | HP_0001644 | I42.0 | — | — | — | — | 2 | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 1 | 1 |
| Hypertrophic cardiomyopathy | D002312 | EFO_0000538 | I42.1 | — | — | — | — | 1 | 1 |
| Hypertrophy | D006984 | EFO_0002460 | — | — | — | — | — | 1 | 1 |
| Central nervous system neoplasms | D016543 | — | — | — | — | — | — | 1 | 1 |
| Nervous system neoplasms | D009423 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Gadoteridol |
| INN | gadoteridol |
| Description | Gadoteridol (INN) is a gadolinium-based MRI contrast agent, used particularly in the imaging of the central nervous system. It is sold under the brand name ProHance. Gadoteridol was first approved for use in the United States in 1992.
|
| 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 | 120066-54-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200593 |
| ChEBI ID | 31643 |
| PubChem CID | 60714 |
| DrugBank | DB00597 |
| UNII ID | 0199MV609F (ChemIDplus, GSRS) |
Target
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,274 documents
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Safety
Black-box Warning
Black-box warning for: Prohance
Adverse Events
Top Adverse Reactions
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3,001 adverse events reported
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