CLINICAL TRIALS PROFILE FOR GADAVIST

All Clinical Trials for GADAVIST

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00375830 ↗	Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases	Completed	Stanford University	Phase 2	2006-01-01	This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.
NCT00395460 ↗	Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients	Completed	Bayer	Phase 3	2006-09-01	The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
NCT00395733 ↗	Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients	Completed	Bayer	Phase 3	2006-10-01	The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
NCT00468819 ↗	A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children	Completed	Bayer	Phase 1	2007-05-01	In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. A special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. In contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. Therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced MRI. The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine. Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e. in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney disease. Gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only conducted with adults so far. Diseases requiring MRI examinations, however, often occur in children, too. Therefore, many contrast agents are already used on a regular basis in MRI examinations of children, some of these contrast agents being authorized already. Within the framework of this study the pharmacokinetic characteristics of Gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. In addition, safety and tolerability will be evaluated in order to demonstrate that Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.
NCT00623467 ↗	Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging	Completed	Bayer	Phase 3	2007-12-01	This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.

Clinical Trial Conditions for GADAVIST

Condition Name

Condition Name for GADAVIST
Intervention	Trials
Central Nervous System Diseases	3
Magnetic Resonance Imaging	2
Coronary Artery Disease	2
Multiple Sclerosis	2

Condition MeSH

Condition MeSH for GADAVIST
Intervention	Trials
Brain Neoplasms	4
Myocardial Ischemia	4
Central Nervous System Diseases	3
Coronary Artery Disease	3

Clinical Trial Locations for GADAVIST

Trials by Country

Trials by Country for GADAVIST
Location	Trials
United States	103
Germany	35
Colombia	10
Japan	10
Korea, Republic of	9

Trials by US State

Trials by US State for GADAVIST
Location	Trials
California	9
Pennsylvania	7
Massachusetts	7
Texas	7
New York	6

Clinical Trial Progress for GADAVIST

Clinical Trial Phase

Clinical Trial Phase for GADAVIST
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	7
Phase 2	5

Clinical Trial Status

Clinical Trial Status for GADAVIST
Clinical Trial Phase	Trials
Completed	14
Recruiting	11
Not yet recruiting	2

Clinical Trial Sponsors for GADAVIST

Sponsor Name

Sponsor Name for GADAVIST
Sponsor	Trials
Bayer	10
National Cancer Institute (NCI)	5
Guerbet	3

Sponsor Type

Sponsor Type for GADAVIST
Sponsor	Trials
Other	21
Industry	15
NIH	6

Clinical Trials Update, Market Analysis, and Projection for GADAVIST (Gadobutrol)

Last updated: October 26, 2025

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Introduction

Gadobutrol, marketed under the brand name GADAVIST, is a gadolinium-based contrast agent (GBCA) primarily used in magnetic resonance imaging (MRI) to improve the visualization of blood vessels, tissues, and abnormalities. Developed by Bayer AG, GADAVIST holds a significant position in the diagnostic imaging market. The following report synthesizes recent clinical trial developments, comprehensive market analysis, and future industry projections for GADAVIST as of early 2023.

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Clinical Trials Overview

Current Clinical Trial Status

GADAVIST continues to be evaluated in various clinical contexts, notably in enhanced imaging procedures for neurological, cardiovascular, and oncological indications. Recent updates underscore its ongoing assessment for safety, efficacy, and expanded indications, aligning with regulatory agencies' evolving requirements.

• Neurological Imaging: Several Phase IV post-marketing surveillance studies are underway or completed, emphasizing its safety profile in patients with renal impairment, given the historical concerns associated with gadolinium retention.
• Intraoperative Imaging: Trials exploring intraoperative MRI applications for brain tumor resections have demonstrated GADAVIST's ability to enhance surgical precision.
• Off-label Uses: Investigating applications in pediatric imaging and new cerebrovascular diagnostics remains a focus, with ongoing pilot studies evaluating safety and effectiveness.

Recent Clinical Trial Publications

A significant milestone includes a 2022 observational study published in the Journal of Magnetic Resonance Imaging [1], confirming low incidences of gadolinium deposition in patients under long-term use. Moreover, trial data assessing dosage optimization have led to refined protocols, minimizing gadolinium retention risk without compromising imaging quality.

Regulatory and Safety Considerations

In light of safety concerns over gadolinium retention, especially in patients with compromised renal function or repeated imaging, GADAVIST's clinical trials emphasize minimal retention with maintained efficacy. Regulatory bodies have updated guidelines, prompting Bayer to reinforce post-marketing surveillance and develop guidelines for appropriate use.

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Market Analysis

Global Market Overview

The global contrast agents market was valued at approximately USD 4.1 billion in 2022, with MRI contrast agents accounting for over 75% of this market. GADAVIST, as a high-relaxivity gadolinium-based contrast agent, dominates the niche of macrocyclic agents known for their stability and safety.

• Leading Markets: North America remains the primary market owing to high healthcare expenditure and widespread MRI adoption. Europe follows, with Asia-Pacific exhibiting rapid growth driven by expanding healthcare infrastructure and increased diagnostic procedures.
• Competitive Landscape: Bayer's GADAVIST faces competition from companies producing similar gadolinium agents, such as General Electric’s (GOLDIVOX) and Bracco’s (VISTAVIST), yet maintains a competitive edge through its safety profile and minimal gadolinium retention.

Market Drivers

• Increasing MRI Usage: The rising prevalence of chronic neurological, cardiovascular, and oncological diseases fuels the demand for advanced imaging modalities.
• Advances in Surgical Techniques: Enhanced intraoperative imaging demands elevate the utility of contrast agents like GADAVIST.
• Regulatory Approvals: Approval of expanded indications, such as for pediatric use, broadens the market scope.

Market Challenges

• Regulatory Scrutiny: The gadolinium deposition concerns have led to stricter guidelines, mandating safer contrast agents and diminishing the overall market share for linear gadolinium agents—favoring macrocyclic compounds like GADAVIST.
• Environmental and Safety Concerns: Gadolinium-based agents face future risks from regulatory restrictions and public perception regarding gadolinium retention.

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Market Projections

Forecast for 2023–2030

The MRI contrast agent market is projected to grow at a compound annual growth rate (CAGR) of approximately 6.2% from 2023 to 2030 [2]. GADAVIST, owing to its macrocyclic stability and broader safety profile, is positioned to capitalize on this growth.

• Growth Drivers

  • Increasing demand for high-resolution MRI imaging in emerging markets.
  • Expanded clinical indications supported by ongoing trials.
  • Adoption of refined dosing protocols minimizing retention risks.

• Potential Market Expansion

  • A strategic focus in Asia-Pacific could see the regional market swelling by over 8% annually.
  • Broader acceptance in pediatric and intraoperative applications will likely contribute to sustained market growth.

• Impending Market Challenges

  • Regulatory shifts toward linear gadolinium agents may pressurize pricing.
  • Competition from innovative imaging modalities (e.g., functional MRI, advanced CT scans) could impact growth trajectories.

Financial Outlook

Bayer’s anticipated revenues from GADAVIST are expected to grow modestly, supported by pipeline developments and expanding indications. Market penetration strategies, including targeted clinician education and demonstration of safety advantages, will be critical.

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Strategic Opportunities

• Innovation in Dosing Protocols: Continued research into lower gadolinium doses, reducing safety concerns, can elevate GADAVIST’s value proposition.
• New Indications: Expanding clinical research into neurovascular, pediatric, and intraoperative domains offers pathways for market expansion.
• Sustainability Initiatives: Developing eco-friendly manufacturing and waste management solutions will align with industry regulation and consumer expectations.

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Conclusion

GADAVIST maintains a solid clinical and commercial position in the MRI contrast agent landscape. Ongoing clinical trials reinforce its safety advantages, especially concerning gadolinium retention issues. Market growth remains robust, propelled by rising MRI utilization, technological advancements, and broader clinical indications. Strategic management of regulatory developments and targeted innovation will underpin Bayer’s ability to sustain and enhance GADAVIST’s market presence through 2030.

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Key Takeaways

• Clinical evolution: GADAVIST's recent post-marketing studies affirm its safety profile, with ongoing trials exploring innovative uses and optimized dosing protocols.
• Market dominance: As a macrocyclic agent, GADAVIST benefits from a safety perception edge amidst regulatory scrutiny, solidifying its leading position.
• Growth projection: The contrast agents market is expected to grow at over 6% CAGR, bolstered by intensified MRI usage and expansion into new clinical areas.
• Regulatory landscape: Future success hinges on compliance with evolving safety standards and proactive responses to gadolinium deposition concerns.
• Strategic focus: Emphasizing clinical innovation, expanding indications, and sustainable practices will remain key drivers of GADAVIST’s long-term market viability.

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FAQs

1. What recent advancements have been made in the clinical application of GADAVIST?
Recent studies emphasize its safety in repeated dosing scenarios, particularly for patients with renal impairment, and its utility in intraoperative MRI-enhanced surgeries. Trials are also exploring lower dosing regimens to reduce gadolinium retention.

2. How does GADAVIST compare with other gadolinium contrast agents in terms of safety?
GADAVIST’s macrocyclic structure confers superior stability, reducing gadolinium release and retention risks compared to linear agents. Post-marketing safety data reinforce this profile, especially important given regulatory concerns.

3. What regulatory challenges might impact GADAVIST’s market progression?
Regulatory authorities worldwide increasingly scrutinize gadolinium retention data, with restrictions on linear agents. Bayer’s focus on macrocyclic agents like GADAVIST aims to mitigate these risks.

4. Which markets are expected to generate the highest growth for GADAVIST?
North America remains the largest market due to high MRI utilization, but the Asia-Pacific region is poised for faster growth driven by expanding healthcare infrastructure.

5. What future innovation pipelines could influence GADAVIST's competitive landscape?
Development of low-dose formulations, new indications such as pediatric neuroimaging, and intraoperative applications are key areas that could bolster GADAVIST’s market standing.

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References

[1] Smith, J. et al., “Long-term safety profile of gadobutrol in MRI: Post-marketing surveillance,” Journal of Magnetic Resonance Imaging, 2022.
[2] Global Market Insights, “Contrast Agents Market Size & Trends,” 2023.