Gadobenate dimeglumine
Multihance (gadobenate dimeglumine) is a small molecule pharmaceutical. Gadobenate dimeglumine was first approved as Multihance on 2004-11-23.
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Commercial
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Multihance, Multihance multipack
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gadobenate dimeglumine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MULTIHANCE | Bracco Diagnostics | N-021357 RX | 2004-11-23 | 4 products, RLD, RS |
| MULTIHANCE MULTIPACK | Bracco Diagnostics | N-021358 RX | 2004-11-23 | 2 products, RLD, RS |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| multihance | New Drug Application | 2024-08-01 |
| multihance multipack | 2008-02-01 |
Indications
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Agency Specific
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Clinical
Clinical Trials
103 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 | — | 4 | 1 | 1 | 3 | 9 |
| Coronary artery disease | D003324 | — | I25.1 | 1 | 2 | 2 | 1 | 3 | 8 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | 1 | 1 | 5 | 8 |
| Magnetic resonance imaging | D008279 | — | — | — | — | 2 | 1 | 1 | 4 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 2 | 1 | 1 | 4 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 2 | 2 | 1 | — | 4 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | 1 | — | 2 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | — | — | 2 | — | 2 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | 1 | — | 1 |
| Positron-emission tomography | D049268 | — | — | — | — | — | 1 | — | 1 |
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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 | 1 | — | 3 | — | 2 | 6 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | 3 | — | 2 | 5 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | 1 | 3 | — | — | 4 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | 1 | 3 | — | — | 4 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | 1 | 2 | — | — | 3 |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | — | 1 | — | 1 | 2 |
| Coronary disease | D003327 | — | — | — | 1 | 1 | — | — | 2 |
| Pathologic constriction | D003251 | — | — | — | — | 2 | — | — | 2 |
| Ischemia | D007511 | EFO_0000556 | — | — | 1 | 1 | — | — | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | 2 | — | — | 5 | 7 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | 2 | 2 | — | — | 2 | 4 |
| Infarction | D007238 | EFO_0009463 | — | 1 | 3 | — | — | 1 | 4 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | — | — | 3 | 4 |
| Sclerosis | D012598 | — | — | — | 1 | — | — | 3 | 4 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | — | — | 3 | 4 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | 2 | 3 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 2 | — | — | 1 | 3 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | 1 | 1 | — | — | — | 1 |
| Primary immunodeficiency diseases | D000081207 | — | — | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | — | 2 | — | — | — | 2 | 4 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | — | — | — | 1 | 3 |
| Gliosarcoma | D018316 | — | — | 1 | — | — | — | 1 | 2 |
| Ependymoma | D004806 | — | — | 1 | — | — | — | 1 | 2 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | — | — | — | 1 | 2 |
| Oligodendroglioma | D009837 | EFO_0000631 | — | 1 | — | — | — | 1 | 2 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Uterine hemorrhage | D014592 | — | — | 1 | — | — | — | — | 1 |
| Leiomyoma | D007889 | HP_0000131 | D25 | 1 | — | — | — | — | 1 |
| Adenomyosis | D062788 | EFO_1001757 | N80.0 | 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 | — | — | — | — | — | — | 4 | 4 |
| Nervous system neoplasms | D009423 | — | — | — | — | — | — | 4 | 4 |
| Carcinoma | D002277 | — | C80.0 | — | — | — | — | 2 | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | — | 2 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 2 | 2 |
| Meniere disease | D008575 | EFO_0006862 | H81.0 | — | — | — | — | 2 | 2 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | — | 2 | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 2 | 2 |
| Fibrosis | D005355 | — | — | — | — | — | — | 2 | 2 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Gadobenate dimeglumine |
| INN | — |
| Description | Gadobenic acid (INN, brand name Multihance) is a complex of gadolinium with the ligand BOPTA. In the form of the methylglucamine salt meglumine gadobenate (INNm) or gadobenate dimeglumine (USAN), it is used as a gadolinium-based MRI contrast medium.
|
| 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 | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200571 |
| ChEBI ID | — |
| PubChem CID | 9852779 |
| DrugBank | DB00743 |
| UNII ID | — |
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Trends
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Safety
Black-box Warning
Black-box warning for: Multihance, Multihance multipack
Adverse Events
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5,738 adverse events reported
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