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
Therapeutic Areas
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Trade Name
FDA
EMA
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 |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| multihance | New Drug Application | 2025-03-16 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Brain diseases | D001927 | — | G93.40 | — | — | — | 2 | — | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | — | 1 | — | 1 |
| Colorectal neoplasms | D015179 | — | — | — | — | — | 1 | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | 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 | — | 1 | — | 2 | 4 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | 1 | — | 2 | 3 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | 2 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
| Intracranial arteriosclerosis | D002537 | EFO_1000860 | I67.2 | — | — | 1 | — | — | 1 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 1 | — | — | 1 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | 1 | — | — | 1 |
| Congenital heart defects | D006330 | — | Q24.9 | — | — | 1 | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Central nervous system neoplasms | D016543 | — | — | — | — | — | — | 2 | 2 |
| Nervous system neoplasms | D009423 | — | — | — | — | — | — | 2 | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | — | 1 | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 1 | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | — | 1 | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | — | 1 | 1 |
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 | 3Q6PPC19PO (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Multihance, Multihance multipack
Adverse Events
Top Adverse Reactions
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5,809 adverse events reported
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