Gadobenic acid

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
Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics	2024/05/09	NCT06406517	Phase 3	Not yet recruiting	University of California, San Diego
Comparison of Contrast Agents in Liver MR for the Detection of Hepatic Metastases	2021/07/22	NCT04973007	Phase 4	Terminated	University of Colorado, Denver
PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer	2021/06/02	NCT04910425	Phase 2	Not yet recruiting	Northwestern University
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years	2020/05/04	NCT04373564	Phase 4	Recruiting	Guerbet
Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions	2019/10/21	NCT04132843	Not Applicable	Completed	M.D. Anderson Cancer Center
Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS	2018/10/12	NCT03703492	Phase 2	Completed	University of Wisconsin, Madison
Retrospective Study of MRI With MULTIHANCE at 0.10 and 0.05 mmol/Kg Dose in CNS Patients	2017/05/10	NCT03147989	N/A	Completed	Bracco Diagnostics, Inc
QSM and Regional DCE MRI Permeability Using GOCART Technique	2017/03/27	NCT03091803	N/A	Withdrawn	University of Southern California
Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases	2016/11/18	NCT02967380	Not Applicable	Terminated	University of Southern California
P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)	2015/12/17	NCT02633501	Phase 2	Completed	Guerbet

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
MultiHance	BRACCO DIAGNOSTICS INC	0270-5164	INTRAVENOUS	529 mg in 1 mL	1/10/2018
MultiHance	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	Patheon Italia S.P.A.	SIN12505P	INJECTION	529 mg/ml	1/30/2004
MULTIHANCE INJECTION 10 ML	Patheon Italia S.P.A.	SIN12504P	INJECTION	529 mg/ml	1/30/2004
MULTIHANCE INJECTION 20 ML	Patheon Italia S.P.A.	SIN12506P	INJECTION	529 mg/ml	1/30/2004

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

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	Bracco Pty Ltd	Medicine	A	7/7/2003
MULTIHANCE gadobenate dimeglumine 5.29g/10mL solution for injection vial	94308	Bracco Pty Ltd	Medicine	A	7/7/2003

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MULTIHANCE	E-Z-Em Canada Inc.	02248302	Solution - Intravenous	529 MG / ML	10/28/2004

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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