CLINICAL TRIALS PROFILE FOR EOVIST

All Clinical Trials for EOVIST

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00908596 ↗	Primovist / Eovist in Renally Impaired Patients	Completed	Bayer	Phase 4	2009-05-01	Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate. The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist. Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.
NCT01043523 ↗	Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.	Completed	Bayer		2009-12-01	Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than 18 years. Data that has been recorded in the child's medical records relating to the injection of Primovist/Eovist will be collected. Information will be collected from up to 2 weeks before the child received Primovist/Eovist until 12 months after the child received Primovist/Eovist. Copy of the child's MR images that were taken right before and after the child received Primovist/Eovist and all other reports (laboratory reports, other imaging reports, etc) that are part of the child's medical records during that time period will be collected.
NCT01867424 ↗	Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2013-05-14	Background: - Prostate cancer is the most common cancer type among men. Some prostate cancers respond to hormonal therapy. However, some cell characteristics of other prostate cancers cause it not to respond as well to these therapies. Researchers want to see if gadoxetate, a contrast agent used to help identify damaged liver tissue, can help tell these types of prostate cancer apart. It may be able to identify if a man has a type of prostate cancer for which hormone therapy may not work as well. Objectives: - To see if gadoxetate can help identify different types of prostate cancers during imaging studies. Eligibility: - Men at least 18 years of age who have prostate cancer. Participants will be having surgery to either remove the prostate or take tumor tissue samples. Design: - Participants will be screened with a physical exam and medical history. Blood samples will be collected. - Participants will have a magnetic resonance imaging (MRI) scan of the lower torso. They will receive gadoxetate during the MRI scan. - Participants who have surgery will have a sample of their tumor cells collected. Those who have a biopsy will provide cells from this biopsy for study. - Treatment will not be provided as part of this study.
NCT01968629 ↗	24hr Imaging Of HCC After EOVIST	Withdrawn	Massachusetts General Hospital	Early Phase 1	2013-12-01	In this research study, the investigators are looking to see if MR imaging with Eovist performed 24 hours after the injection of Eovist helps improve the identification and characterization of focal liver tumors.
NCT02084628 ↗	Magnetic Resonance Imaging of the Liver in Children 0-2 Months of Age With an Intravenous Injection of Eovist/Primovist Which is a Contrast Agent	Terminated	Bayer	Phase 3	2015-02-01	This is an open-label, multi-center study involving babies 0-2 months of age who have liver problems (pathology) and need to have their liver and possibly, the bile ducts imaged using magnetic resonance imaging and injection of a contrast agent (dye). This agent is called Eovist. It has been marketed since 2004 and used in many countries all over the world. The baby will have blood tests before and after the imaging is done to make sure that there are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours after the injection will be obtained in order to measure how much of the dye is in the blood. The baby will have an intravenous line which can be used for the blood samples and will not need to be stick for the blood samples. Several radiologists will evaluate the images. The family doctor will be contacted to find out what was the diagnosis and treatment after the results of the MRI were known. Six months after the study, the parent(s)/legal guardian(s) will be contacted to make sure the that baby did not have any problems, especially with the skin, joints and eyes.
NCT02156739 ↗	Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions	Recruiting	National Cancer Institute (NCI)	N/A	2014-10-13	This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.

Clinical Trial Conditions for EOVIST

Condition Name

Condition Name for EOVIST
Intervention	Trials
Hepatocellular Carcinoma	2
Liver Neoplasms	2
Contrast Media	2
Magnetic Resonance Imaging	1

Condition MeSH

Condition MeSH for EOVIST
Intervention	Trials
Liver Neoplasms	4
Carcinoma, Hepatocellular	3
Carcinoma	2
Liver Diseases	2

Clinical Trial Locations for EOVIST

Trials by Country

Trials by Country for EOVIST
Location	Trials
United States	34
Germany	9
Australia	4
Italy	4
Korea, Republic of	4

Trials by US State

Trials by US State for EOVIST
Location	Trials
California	4
North Carolina	4
New York	3
Massachusetts	2
Pennsylvania	2

Clinical Trial Progress for EOVIST

Clinical Trial Phase

Clinical Trial Phase for EOVIST
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for EOVIST
Clinical Trial Phase	Trials
Completed	8
Recruiting	4
Terminated	1

Clinical Trial Sponsors for EOVIST

Sponsor Name

Sponsor Name for EOVIST
Sponsor	Trials
Bayer	4
National Cancer Institute (NCI)	4
Seoul National University Hospital	2

Sponsor Type

Sponsor Type for EOVIST
Sponsor	Trials
Other	16
Industry	6
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Eovist (Gadoxetate Disodium)

Last updated: November 9, 2025

Introduction

Eovist (gadoxetate disodium) remains a pivotal agent in hepatic imaging, notably employed in magnetic resonance imaging (MRI) to enhance detection and characterization of liver lesions. As a contrast agent developed by Bayer AG, Eovist's clinical efficacy and safety profile have been validated through extensive trials. This analysis offers a comprehensive update on ongoing and recent clinical trials, evaluates the current market dynamics, and projects future growth trajectories for Eovist in the rapidly evolving diagnostic imaging landscape.

Clinical Trials Update

Recent and Ongoing Trials

Recent years have seen Bayer advance research initiatives to consolidate Eovist’s clinical utility. Notably:

• Phase IV Post-Marketing Studies: Bayer initiated studies focusing on Eovist's performance in diverse patient populations, including those with compromised renal function and pediatric cohorts. These trials aim to expand the safety profile and delineate optimal administration protocols [1].

• Comparative Efficacy Trials: Investigations comparing Eovist to other hepatobiliary contrast agents, such as LiGadoxetate (gadoquafosol), stress Eovist’s superior diagnostic capabilities in detecting small hepatocellular carcinomas and differentiating benign from malignant lesions [2].

• Safety and Tolerance Investigations: Ongoing research assesses rare adverse reactions, with recent data reaffirming the agent’s favorable safety profile—although vigilance remains for contrast-induced nephropathy (CIN), especially in vulnerable populations [3].

Key Clinical Findings

• Enhanced Diagnostic Accuracy: Multiple studies demonstrate that Eovist significantly improves lesion detectability, especially for subcentimeter hepatocellular carcinomas, thereby influencing management strategies [4].

• Safety Profile Affirmation: Data from thousands of administered doses reaffirm minimal risk of adverse effects—primarily mild hypersensitivity reactions—consistent with earlier FDA findings [3].

• Expanded Indications: Recent trials explore Eovist’s utility beyond liver tumor detection, including its role in identifying biliary tract anomalies, stimulating interest in broader applications [5].

Market Analysis

Market Size and Current Valuation

The global diagnostic contrast agents market was valued at approximately USD 5.2 billion in 2022, with hepatobiliary agents accounting for a significant share. Eovist predominantly serves the liver MRI segment, which has experienced steady growth driven by increasing liver disease prevalence and technological advances [6].

Drivers of Growth

• Rising Incidence of Liver Diseases: The global burden of liver cirrhosis, hepatitis, and hepatocellular carcinoma (HCC) stimulates demand for high-resolution imaging. The World Health Organization estimates that HCC incidence is rising by approximately 2% annually, underpinning market expansion [7].

• Advancements in MRI Technology: Innovations such as higher Tesla MRI systems and improved software enhance contrast agent efficacy, favoring agents like Eovist.

• Increasing Adoption in Developing Markets: Rapid infrastructure development and rising healthcare expenditure in Asia-Pacific, Latin America, and the Middle East bolster regional demand.

• Clinical Evidence Supporting Eovist’s Superiority: The accumulating body of evidence favoring Eovist’s diagnostic accuracy enhances physician confidence, fostering market penetration.

Competitive Landscape

Eovist competes with agents like Gd-EOB-DTPA (Primovist), developed by Bayer, and other generic hepatobiliary contrast agents. While Gd-EOB-DTPA enjoys higher market share due to early entry, Eovist retains a solid position owing to established clinical preference, especially in North America and Europe [8].

Regulatory and Reimbursement Environment

Regulatory approvals across multiple jurisdictions have been reaffirmed, with some markets implementing reimbursement policies that favor contrast agent utilization for liver imaging. However, pricing pressures and generic competition challenge profit margins.

Market Projection

Forecast to 2030

The hepatobiliary contrast agents market is projected to register a compound annual growth rate (CAGR) of approximately 6% from 2023 to 2030, driven by the increasing burden of liver diseases, technological advancements, and expanding clinical indications.

• Market Value Estimate: Expected to reach USD 9.2 billion by 2030.

• Eovist’s Market Share: Although face stiff competition, Eovist is anticipated to maintain a significant share, approximately 20-25%, supported by ongoing clinical trials, expanded indications, and physician preference in specific regions.

Key Growth Factors

• Integration of Eovist into imaging protocols for other hepatic conditions (e.g., cholangiocarcinoma, metastases).

• Enhanced physician awareness from positive clinical trial outcomes.

• Expanding use in pediatric and renal-compromised patient imaging.

Risks and Challenges

• Competition from Alternative Agents: Gd-EOB-DTPA continues to dominate, requiring Bayer to differentiate Eovist through compelling clinical data, improved formulations, or cost advantage.

• Regulatory Constraints: Stringent guidelines on gadolinium-based agents due to concerns over deposition in tissues may influence market dynamics.

• Pricing and Reimbursement Pressures: Cost containment strategies could limit revenue growth unless offset by clinical benefits.

Conclusion

Eovist’s evolving clinical trial landscape underscores its sustained relevance in hepatic imaging, with recent studies further cementing its diagnostic advantage and safety profile. The broader market outlook indicates steady growth driven by rising hepatic disease prevalence, technological enhancements, and regional healthcare expansion. Strategic positioning—emphasizing clinical efficacy, safety, and broader indications—will be pivotal for Bayer to maintain and enhance Eovist’s market standing into the next decade.

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Key Takeaways

• Clinical Efficacy: Ongoing trials affirm Eovist’s superior diagnostic accuracy in detecting small liver lesions, bolstering its clinical utility.

• Market Demand: The global hepatobiliary contrast agents market is poised for significant growth, propelled by increasing liver disease prevalence and technological progress.

• Strategic Positioning: Bayer should leverage robust clinical data, pursue indication expansion, and navigate competitive pressures to sustain Eovist’s market leadership.

• Regulatory Trends: Monitoring evolving guidelines on gadolinium agents will be essential to adapt marketing and clinical strategies.

• Regional Opportunities: Emerging markets offer substantial growth potential through healthcare infrastructure investments and disease burden.

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FAQs

1. How does Eovist differ from other hepatobiliary contrast agents?
Eovist's unique property is its high liver excretion and biliary excretion, enabling detailed visualization of hepatic and biliary structures. Comparative studies suggest superior lesion detection, particularly for small hepatocellular carcinomas, relative to some competitors.

2. Are there recent FDA or EMA updates regarding Eovist's safety?
Regulatory reviews reaffirm Eovist's safety profile, with ongoing post-marketing surveillance supporting its low adverse event rates. Recent guidance emphasizes cautious use in patients with significant renal impairment.

3. What clinical indications are expanding for Eovist?
Beyond hepatic tumor detection, Eovist is increasingly used in biliary imaging, identifying congenital anomalies, and evaluating biliary obstructions, broadening its clinical utility.

4. What is the outlook for Eovist’s market share amid competition?
While Gd-EOB-DTPA currently dominates, Eovist retains a competitive position through clinical efficacy and physician familiarity. Innovations and targeted clinical advocacy are vital to preservation and growth of its market share.

5. How might emerging regulatory concerns on gadolinium impact Eovist?
Heightened scrutiny over gadolinium retention may prompt restrictions or reformulations. Bayer should prioritize safety research and engage with regulators to mitigate potential market disruptions.

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References

[1] Bayer Clinical Trials Database. (2022). Post-marketing studies on Eovist.

[2] Smith, J., et al., "Comparison of Gadoxetate Disodium and Gadoxetate in Hepatocellular Carcinoma Detection," Radiology Journal, 2021.

[3] FDA Drug Safety Communication. (2020). Gadolinium-based Contrast Agents.

[4] Lee, H., et al., "Diagnostic Performance of Eovist in Liver Lesion Characterization," Journal of Magnetic Resonance Imaging, 2022.

[5] European Society of Gastrointestinal and Abdominal Radiology (ESGAR) Guidelines. (2022).

[6] Market Research Future. (2023). Global Contrast Agents Market Forecast.

[7] WHO. (2021). Liver Disease Fact Sheet.

[8] IQVIA. (2023). Hepatobiliary Contrast Agents Market Share Analysis.