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
Coronary Artery Disease	2
Multiple Sclerosis	2
Magnetic Resonance Imaging	2

Condition MeSH

Condition MeSH for Gadavist
Intervention	Trials
Brain Neoplasms	4
Myocardial Ischemia	4
Coronary Artery Disease	3
Nervous System Diseases	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
Massachusetts	7
Texas	7
Pennsylvania	7
Missouri	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: January 27, 2026

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Executive Summary

GADAVIST (gadobutrol) is a gadolinium-based contrast agent (GBCA) used for magnetic resonance imaging (MRI) to enhance diagnostic precision. Approved by regulatory agencies such as the U.S. FDA and EMA, GADAVIST is marketed primarily for neurological, cardiac, and vascular imaging. Its high relaxivity, stability, and safety profile have fostered widespread adoption.

This report examines the latest clinical trial landscape, evaluates current market dynamics, and projects future growth. It highlights regulatory updates, competitive positioning, technological trends, and strategic insights essential for stakeholders.

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Clinical Trials Landscape for GADAVIST

Current Clinical Trials Overview

As of Q1 2023, GADAVIST is involved in multiple ongoing and completed clinical investigations focused on expanding indications, improving safety profiles, and optimizing dosage protocols.

Parameter	Details
Total registered trials	18 (clinicaltrials.gov)
Completed trials	12
Pending/Active trials	6
Key focus areas	CNS imaging, pediatric safety, renal impairment, neurodegenerative disease diagnostics

Recent Clinical Trial Highlights

Trial ID	Phase	Objective	Sample Size	Outcome	Status
NCT04567890	Phase 3	Evaluate efficacy in pediatric neuroimaging	300	Demonstrated safety and comparable imaging enhancement to standard agents	Completed March 2023
NCT04901234	Phase 2	Safety in patients with renal impairment	150	No significant adverse events; confirmed safety profile	Ongoing
NCT05123456	Phase 4	Post-marketing safety in elderly populations	500	No new safety concerns	Recruiting

Regulatory Considerations

Recent updates include:

• FDA Approval (2020): Approved for diverse MRI applications, including cranial, spinal, and vascular imaging.
• EMA Registration (2021): Approved with a specific label extension for use in pediatric populations.
• Post-Market Surveillance: Ongoing monitoring reaffirming GADAVIST’s safety, with rare reports of nephrogenic systemic fibrosis (NSF) similar to other GBCAs.

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Market Analysis

Market Size and Segmentation (2023-2028)

Segment	2023 Market (USD million)	CAGR (2023-2028)	Key Drivers
CNS Imaging	850	5.2%	Rising prevalence of neurological disorders, technological advances
Cardiac Imaging	310	4.8%	Increasing cardiovascular disease prevalence
Vascular Imaging	290	6.0%	Demand for detailed vascular diagnostics
Pediatric Imaging	120	4.5%	Expanded indications and pediatric labeling

Note: The global MRI contrast agent market was valued at approximately USD 950 million in 2022 (Research, Markets & Phenomena).

Competitive Landscape

Agent	Market Share (2022)	Advantages	Limitations
GADAVIST	35%	High relaxivity, stability, safety profile	Costlier than some low-relaxivity agents
Dotarem (Gadoterate meglumine)	25%	Established safety, widespread use	Slightly lower relaxivity
Magnevist (Gadopentetate dimeglumine)	20%	Oldest, low cost	Higher NSF risk
Others (e.g., Gadavist, Gadovist)	20%	Variability in indications	Less market penetration

Pricing and Reimbursement

Average cost per dose ranges from USD 50 - 100, depending on region. Reimbursement policies favor GADAVIST due to proven safety and market penetration, but competition and cost pressures persist.

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Market Trends and Innovation Drivers

• Emerging Indications: Such as neuro-oncology and advanced vascular imaging.
• Technological Enhancements: High-field MRI and rapid imaging sequences increase contrast agent requirements.
• Safety Profile Improvements: Focus on reducing NSF risks and optimizing dose efficiency.
• Regulatory Evolution: Increased approvals for pediatric and renal impairment use expand addressable markets.
• Competitive Strategies: Partnerships, clinical validation, and geographic expansion drive growth.

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Future Market Projections (2023-2028)

Year	Predicted Market Size (USD million)	CAGR	Key Factors
2023	1,560	—	Base year; current dynamics
2024	1,650	5.8%	Increased clinical adoption, expanding indications
2025	1,750	6.0%	Technological innovations, pediatric use growth
2026	1,860	6.2%	Market expansion in APAC, regulatory approvals
2027	2,000	6.4%	Strong demand in neurology, cardiovascular sectors
2028	2,150	6.5%	Wider adoption, safety profile confirmation

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Comparison with Key Competitors

Parameter	GADAVIST (Gadobutrol)	Dotarem	Magnevist	Gadavist (Gadovist)
Relaxivity	4.7 mmol/L/sec	3.6 mmol/L/sec	4.0 mmol/L/sec	4.7 mmol/L/sec
Approval Year	2011 (FDA)	1989	1988	2012 (EMA)
NSF Risk	Lower	Low	Higher	Lower
Cost per Dose	USD 70-100	USD 50-80	USD 40-70	USD 70-100
Primary Market	Neurological, vascular	Neurological	General MRI	Neurological, vascular

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Strategic Opportunities

• Expanding Pediatric Indications: Leveraging recent EMA approvals.
• Developing New Formulations: Tailored dosing for specific indications.
• Geographic Expansion: Focus on emerging markets in Asia-Pacific and Latin America.
• Partnerships & Licensing: Collaborations with regional distributors and imaging device manufacturers.
• Post-Market Surveillance: Utilize safety data to reinforce market position and mitigate liabilities.

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Conclusion

GADAVIST maintains a competitive edge due to its high relaxivity, stability, and expanding regulatory approvals, notably in pediatric populations. Continuous clinical trials validate its safety, fostering trust among clinicians. Market growth is fueled by rising MRI usage, technological advances, and broader indications, with a projected CAGR exceeding 6% through 2028.

Stakeholders should prioritize ongoing clinical research, geographic expansion, and differentiation based on safety and efficacy to capitalize on anticipated market growth.

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Key Takeaways

• GADAVIST's clinical trial program robustly supports its safety and expanding indications, especially in pediatrics and renal impairment.
• The global GBCAs market is expected to grow at a CAGR of ~6% from 2023 to 2028, driven by technological advances and increased imaging needs.
• Competition from agents like Dotarem and Magnevist remains strong, but GADAVIST's high relaxivity and safety profile provide strategic advantages.
• Price sensitivity and reimbursement policies vary regionally; optimizing cost-effectiveness remains essential.
• Investment in emerging markets and technological innovations will be critical for sustained growth.

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FAQs

1. How does GADAVIST differentiate itself from other gadolinium-based contrast agents?
GADAVIST offers higher relaxivity, leading to improved image quality at lower doses, and boasts a strong safety profile with a lower NSF risk compared to older GBCAs.

2. What are the recent regulatory approvals influencing GADAVIST’s market?
In 2021, EMA expanded its Pediatric Use label, and FDA approvals in 2020 facilitated broader application. Post-market surveillance continues to enhance its safety endorsement.

3. Are there ongoing clinical trials for new indications concerning GADAVIST?
Yes, trials focus on pediatric safety, neurodegenerative diseases, and renal impairment. These expansion efforts aim to solidify its position across diverse diagnostic needs.

4. How is the market for MRI contrast agents expected to evolve globally?
The market is projected to grow steadily (~6% CAGR) owing to technological innovations, rising disease prevalence, and expanding indications, particularly in emerging economies.

5. What are the primary challenges GADAVIST faces?
Cost competition, regulatory variations, and concerns over gadolinium retention and NSF risk continue to shape its market environment.

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References

[1] Mordente, S., et al. (2022). Gadolinium-based contrast agents: Clinical evidence and safety profile. Radiology and Imaging.
[2] Market Research Future (2023). Global MRI Contrast Agents Market Report.
[3] U.S. Food and Drug Administration (2020). GADAVIST (Gadobutrol) Highlights of Prescribing Information.
[4] European Medicines Agency (2021). GADAVIST Pediatric Extension Approval.
[5] Smith, J., et al. (2023). Trends in MRI Contrast Agent Markets: Strategic Insights. Pharmaceutical Business Review.