Overview
Gadobenic acid (in the form of gadobenate dimeglumine) is an MRI contrast agent used primarily for MR imaging of the liver. It can also be used for visualizing the CNS and heart. In contrast to conventional extracellular fluid contrast agents, gadobenate dimeglumine is characterized by a weak and transient binding capacity to serum proteins. This binding leads to an increased relaxivity of gadobenate dimeglumine and, consequently, to a considerably increased signal intensity over that of other agents.
Indication
Gadobenate dimeglumine is indicated for use in magnetic resonance imaging (MRI) of the central nervous system in adult and pediatric patients in order to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues. It is also indicated for use in magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
Associated Conditions
- Vascular Occlusion
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/09 | Phase 3 | Not yet recruiting | |||
2021/07/22 | Phase 4 | Terminated | |||
2021/06/02 | Phase 2 | Not yet recruiting | |||
2020/05/04 | Phase 4 | Recruiting | |||
2019/10/21 | Not Applicable | Completed | |||
2018/10/12 | Phase 2 | Completed | |||
2017/05/10 | N/A | Completed | |||
2017/03/27 | N/A | Withdrawn | |||
2016/11/18 | Not Applicable | Terminated | |||
2015/12/17 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| BRACCO DIAGNOSTICS INC | 0270-5164 | INTRAVENOUS | 529 mg in 1 mL | 1/10/2018 | |
| BRACCO DIAGNOSTICS INC | 0270-5264 | INTRAVENOUS | 529 mg in 1 mL | 11/10/2016 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| MULTIHANCE INJECTION 15 ML | SIN12505P | INJECTION | 529 mg/ml | 1/30/2004 | |
| MULTIHANCE INJECTION 10 ML | SIN12504P | INJECTION | 529 mg/ml | 1/30/2004 | |
| MULTIHANCE INJECTION 20 ML | SIN12506P | INJECTION | 529 mg/ml | 1/30/2004 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Gadobenate Dimeglumnine Injection | 国药准字H20054702 | 化学药品 | 注射剂 | 2/21/2024 | |
| Gadobenate Dimeglumnine Injection | 国药准字H20054701 | 化学药品 | 注射剂 | 2/21/2024 | |
| Gadobenate Dimeglumnine Injection | 国药准字H20054703 | 化学药品 | 注射剂 | 2/21/2024 | |
| Gadobenate Dimeglumnine Injection | 国药准字H20243792 | 化学药品 | 注射剂 | 5/21/2024 | |
| Gadobenate Dimeglumnine Injection | 国药准字H20243089 | 化学药品 | 注射剂 | 1/23/2024 | |
| Gadobenate Dimeglumnine Injection | 国药准字H20203008 | 化学药品 | 注射剂 | 1/15/2020 | |
| Gadobenate Dimeglumnine Injection | 国药准字H20249012 | 化学药品 | 注射剂 | 9/26/2024 | |
| Gadobenate Dimeglumnine Injection | 国药准字HJ20140922 | 化学药品 | 注射剂 | 6/16/2021 | |
| Gadobenate Dimeglumnine Injection | 国药准字HJ20140921 | 化学药品 | 注射剂 | 6/16/2021 | |
| Gadobenate Dimeglumnine Injection | 国药准字HJ20140924 | 化学药品 | 注射剂 | 6/16/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MULTIHANCE gadobenate dimeglumine 10.58g/20mL solution for injection vial | 94310 | Medicine | A | 7/7/2003 | |
| MULTIHANCE gadobenate dimeglumine 5.29g/10mL solution for injection vial | 94308 | Medicine | A | 7/7/2003 |
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