CLINICAL TRIALS PROFILE FOR GADOBENATE DIMEGLUMINE

All Clinical Trials for Gadobenate Dimeglumine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00323310 ↗	Safety and Efficacy of MultiHance in Pediatric Patients	Terminated	Bracco Diagnostics, Inc	Phase 3	2006-04-01	The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.
NCT00395863 ↗	Multihance at 3 Tesla (3T) in Brain Tumors	Completed	Bracco Diagnostics, Inc	Phase 4	2006-11-01	Compare the efficacy of MultiHance and Magnevist
NCT01165892 ↗	Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar)	Completed	Lantheus Medical Imaging		2011-07-01	The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).
NCT01165892 ↗	Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar)	Completed	Washington University School of Medicine		2011-07-01	The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).
NCT01260636 ↗	Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries	Completed	Bracco Diagnostics, Inc	Phase 3	2009-09-01	To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries
NCT01710254 ↗	Regadenoson Stress-MRI to Identify Coronary Artery Disease in Atrial Fibrillation Patients	Completed	University of Utah	Phase 2	2013-01-01	Atrial fibrillation (AF) is growing into an epidemic affecting 1 in 4 adults. There is a need for research to elucidate the prevalence of ischemic cardiomyopathy in patients diagnosed with AF. The objective of this study is to demonstrate the utility of MRI in assessment of coronary artery disease. The specific objective is to demonstrate sensitivity/specificity comparable to that reported in meta-analyses of non-AF patients and adenosine (90% /80%) in an AF population using the time-efficient vasodilator regadenoson that requires only a single intravenous (IV).
NCT02226666 ↗	Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration	Completed	University of Michigan		2013-08-01	The purpose of this study is to prospectively compare the physiologic response of patients who receive either intravenous gadoxetic acid (Eovist) or intravenous gadobenate dimeglumine (MultiHance).

Clinical Trial Conditions for Gadobenate Dimeglumine

Condition Name

Condition Name for Gadobenate Dimeglumine
Intervention	Trials
Breast Cancer	2
Carotid, Aortic, Renal or Peripheral Artery Disease	1
Adult Choroid Plexus Neoplasm	1
Liver Tumor	1

Condition MeSH

Condition MeSH for Gadobenate Dimeglumine
Intervention	Trials
Brain Neoplasms	3
Nervous System Diseases	2
Central Nervous System Diseases	2
Breast Neoplasms	2

Clinical Trial Locations for Gadobenate Dimeglumine

Trials by Country

Trials by Country for Gadobenate Dimeglumine
Location	Trials
United States	23
Belgium	1
Hungary	1
Mexico	1
China	1

Trials by US State

Trials by US State for Gadobenate Dimeglumine
Location	Trials
Illinois	3
Wisconsin	2
Texas	2
Massachusetts	2
California	2

Clinical Trial Progress for Gadobenate Dimeglumine

Clinical Trial Phase

Clinical Trial Phase for Gadobenate Dimeglumine
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Gadobenate Dimeglumine
Clinical Trial Phase	Trials
Completed	7
Recruiting	5
Terminated	3

Clinical Trial Sponsors for Gadobenate Dimeglumine

Sponsor Name

Sponsor Name for Gadobenate Dimeglumine
Sponsor	Trials
National Cancer Institute (NCI)	6
Bracco Diagnostics, Inc	5
Guerbet	2

Sponsor Type

Sponsor Type for Gadobenate Dimeglumine
Sponsor	Trials
Other	14
Industry	8
NIH	6

Gadobenate Dimeglumine: Clinical Trials, Market Analysis, and Projections

Introduction

Gadobenate dimeglumine, marketed under the trade name MultiHance, is a gadolinium-based contrast agent used in magnetic resonance imaging (MRI) to enhance the visibility of internal body structures. This article provides an update on the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Safety Profile

Adult Clinical Trials

Clinical trials involving gadobenate dimeglumine have demonstrated its safety and efficacy. In studies involving 2540 adult and pediatric subjects, the overall incidence of adverse events (AEs) was 19.8% for adult patients, with most events being non-serious, mild, and transient[2].

Key adverse events reported included headache, injection site reaction, nausea, taste perversion, and vasodilation, occurring with a frequency of between 1.0% and 2.6%. Serious AEs potentially related to gadobenate dimeglumine were rare, reported in only 0.2% of patients[2].

Pediatric Clinical Trials

For pediatric patients, the safety and efficacy of gadobenate dimeglumine were evaluated in several studies. However, initial studies had design flaws and insufficient data, particularly for patients between 2 and 5 years old. Additional data submitted later addressed these deficiencies and supported the safe and effective use of MultiHance in pediatric patients aged 2 to <16 years[4].

Pharmacodynamics and Pharmacokinetics

Gadobenate dimeglumine demonstrates unique pharmacodynamic properties, including weak and transient interactions with serum proteins, which enhance its relaxivity and thus improve the contrast-to-noise ratio and lesion-to-brain ratio in MRI images[3].

Pharmacokinetic studies in healthy male subjects showed that gadobenate dimeglumine is rapidly distributed and eliminated, primarily through the kidneys[3].

Market Analysis

Global Market Overview

The global gadolinium contrast media market is segmented by type, application, and region. Gadobenate dimeglumine is one of the key types of gadolinium-based contrast agents, alongside others such as gadobutrol, gadopentetate dimeglumine, and gadoterate meglumine[5].

Market Size and Growth

The global gadolinium contrast media market is expected to grow at a significant compound annual growth rate (CAGR) from 2024 to 2031. The market size is estimated to increase driven by the increasing demand for MRI procedures and the advancement in diagnostic technologies[5].

Regional Analysis

The market is segmented into major regions including North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region's revenue share and current trends are analyzed to provide a comprehensive market overview. Asia-Pacific is expected to be a significant growth driver due to the increasing healthcare infrastructure and diagnostic needs[5].

Key Players

The market for gadolinium contrast media is competitive, with key players including Bracco Diagnostics Inc., Bayer, Takeda, Fuji Pharma, and Guerbet. Bracco Diagnostics Inc. is the primary manufacturer of MultiHance (gadobenate dimeglumine)[5].

Market Projections

Future Trends

The demand for gadolinium-based contrast agents, including gadobenate dimeglumine, is expected to rise due to the increasing prevalence of diseases that require advanced diagnostic imaging. The market will also be driven by technological advancements in MRI and the expanding healthcare infrastructure in emerging economies[5].

Application-Specific Growth

Hospitals and clinics are the primary end-users of gadolinium contrast media. The growth in these sectors, particularly in the Asia-Pacific region, will drive the demand for gadobenate dimeglumine. The use of MultiHance in specialized MRI procedures, such as central nervous system imaging, will continue to be a significant market driver[5].

Key Takeaways

• Clinical Safety: Gadobenate dimeglumine has a strong safety profile with most adverse events being mild and transient.
• Market Growth: The global market for gadolinium contrast media is expected to grow significantly, driven by increasing diagnostic needs and technological advancements.
• Regional Focus: Asia-Pacific is anticipated to be a key growth region due to expanding healthcare infrastructure.
• Competitive Landscape: Bracco Diagnostics Inc. is a major player in the market for gadobenate dimeglumine.

FAQs

What are the most common adverse events associated with gadobenate dimeglumine?

The most common adverse events include headache, injection site reaction, nausea, taste perversion, and vasodilation, occurring with a frequency of between 1.0% and 2.6%[2].

How does gadobenate dimeglumine enhance MRI images?

Gadobenate dimeglumine enhances MRI images by shortening the T1 and T2 relaxation times of adjacent water molecules, particularly through its unique interactions with serum proteins which increase its relaxivity[3].

What is the primary application of gadobenate dimeglumine in MRI?

The primary application is in the imaging of the central nervous system, where it helps in visualizing lesions such as neoplasms, abscesses, and infarcts by crossing disrupted blood-brain barriers[3].

Which region is expected to dominate the global gadolinium contrast media market?

The Asia-Pacific region is expected to be a significant growth driver due to the increasing healthcare infrastructure and diagnostic needs[5].

Who are the key manufacturers of gadobenate dimeglumine?

Bracco Diagnostics Inc. is the primary manufacturer of MultiHance (gadobenate dimeglumine)[5].

Sources

1. Safety assessment of gadopentetate dimeglumine in U.S. clinical trials - PubMed
2. Safety assessment of gadobenate dimeglumine (MultiHance) - PubMed
3. Multihance (gadobenate dimeglumine) injection label - FDA
4. 021357 Gadobendate Clinical PREA - FDA - FDA
5. Gadolinium Contrast Media Market Report 2024 (Global Edition) - Cognitive Market Research