CLINICAL TRIALS PROFILE FOR ISOVUE-250

All Clinical Trials for ISOVUE-250

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX-CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Averion International Corporation	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Clinical Trial Conditions for ISOVUE-250

Condition Name

Condition Name for ISOVUE-250
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Kidney Diseases	1

Condition MeSH

Condition MeSH for ISOVUE-250
Intervention	Trials
Renal Insufficiency	3
Kidney Diseases	3
Diabetes Mellitus	2

Clinical Trial Locations for ISOVUE-250

Trials by Country

Trials by Country for ISOVUE-250
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for ISOVUE-250
Location	Trials
New Jersey	11
Texas	1
Nebraska	1
California	1
North Carolina	1

Clinical Trial Progress for ISOVUE-250

Clinical Trial Phase

Clinical Trial Phase for ISOVUE-250
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ISOVUE-250
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for ISOVUE-250

Sponsor Name

Sponsor Name for ISOVUE-250
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Duke University	2

Sponsor Type

Sponsor Type for ISOVUE-250
Sponsor	Trials
Industry	21
Other	9
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Isovue-250

Last updated: October 28, 2025

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Introduction

Isovue-250 (iopamidol) is an iodinated contrast agent primarily utilized in diagnostic imaging procedures, particularly in computed tomography (CT) scans. Its high radiopacity enhances vascular and tissue delineation, making it a critical tool in radiology. As healthcare increasingly emphasizes precision diagnostics, the demand for contrast agents like Isovue-250 is poised for strategic growth. This article provides an in-depth analysis of recent clinical trial developments, examines the current market landscape, and offers future projections for Isovue-250.

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Clinical Trials Update

Ongoing and Recent Clinical Research

Recent clinical trials involving Isovue-250 have focused on optimizing its safety and efficacy profile, especially in vulnerable populations such as pediatric and renal-impaired patients. The product’s safety profile remains robust, with studies reaffirming its low incidence of adverse reactions—primarily mild hypersensitivity. No recent high-profile randomized controlled trials (RCTs) have been published specifically targeting Isovue-250; however, numerous observational studies and meta-analyses underscore its clinical utility.

Key Clinical Studies:

• Safety in Renal Impairment: Multiple studies suggest that Isovue-250, when used judiciously, displays a tolerable profile in patients with compromised renal function. Renal safety remains under scrutiny, with ongoing trials examining the optimal contrast dosage to mitigate nephrotoxicity—particularly relevant given the increasing prevalence of chronic kidney disease (CKD).

• Pediatric Applications: Recent research emphasizes the importance of dose adjustments and contrast administration protocols tailored to pediatric patients. These investigations aim to expand the safe use of Isovue-250 in children, especially in complex imaging procedures.

• Innovation in Imaging Techniques: Trials exploring enhanced imaging modalities—such as dual-energy CT—demonstrate that Isovue-250's optimal concentration improves luminal delineation and tissue contrast, enabling more precise diagnoses.

Regulatory and Post-Marketing Surveillance

Regulatory bodies like the U.S. FDA continue to monitor the adverse event reports related to iodinated contrast media. Post-marketing surveillance data indicate high tolerability, with hypersensitivity reactions being rare (<1%). The manufacturer remains committed to updating safety profiles through real-world evidence studies.

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Market Analysis

Global Market Landscape

The contrast media market is projected to expand at a compound annual growth rate (CAGR) of approximately 6-8% through 2028, driven by an expanding diagnostic imaging need, technological advancements, and aging populations. The North American region dominates the market owing to high healthcare expenditure, mature infrastructure, and prevalent use of advanced imaging.

Competitive Environment

Isovue-250 competes against other iodinated contrast agents, notably:

• Iohexol (Omnipaque): Widely used, with a diversified portfolio.
• Visipaque (iodixanol): A non-ionic, iso-osmolar contrast agent, favored for its safety profile in renal impairment.
• Lodoxanol and other agents: Limited regional penetration but relevant in specific contexts.

Market Drivers:

• Increase in Diagnostic Imaging Procedures: The rising incidence of cardiovascular, oncological, and neurological conditions fuels demand.
• Technological Advancements: Innovations like dual-energy CT and low-dose protocols enhance contrast agent utility.
• Aging Population: The elderly, more prone to cardiovascular and renal diseases, represent significant demand for contrast media.

Market Challenges:

• Safety Concerns: Allergic reactions and nephrotoxicity, although rare, necessitate ongoing vigilance.
• Regulatory Scrutiny: Post-market safety data influence regulatory guidance and labeling.
• Cost Pressures: Pricing strategies and reimbursement policies impact profit margins.

Market Share and Revenue

According to recent market reports, Isovue holds approximately 15-20% share in the global iodinated contrast agent segment, with revenues estimated around $200-250 million annually. Peak sales are observed in North America, with notable growth in Asia-Pacific regions, driven by improving healthcare infrastructure.

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Future Market Projections

Growth Outlook (2023-2030)

The outlook for Isovue-250 is cautiously optimistic, contingent on several macro and microeconomic factors:

• Adoption in Emerging Markets: As healthcare infrastructure develops, the demand for high-quality contrast agents like Isovue-250 is expected to rise. Asia-Pacific markets could represent a 10-12% CAGR from 2023 to 2030.

• Technological Advances: The integration of low-contrast-dose imaging protocols and dual-energy CT could broaden clinical applications, supporting increased usage.

• Innovative Formulations: The development of lower-osmolar or iso-osmolar variants may sharpen competitive advantage, potentially expanding label indications.

• Regulatory Environment: Stringent safety standards may lead to formulation improvements or new labeling, possibly restricting or expanding usage depending on outcomes.

Forecasted Revenue

By 2030, the global iodinated contrast media market could surpass $2.5 billion, with Isovue-250 capturing a significant share due to its established safety profile and versatility. Revenues could reach $300-350 million, driven predominantly by US and Asia-Pacific demand. Growth is expected to stabilize as market saturation occurs but will be augmented by technological adoption and expanding diagnostic needs.

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Strategic Implications

• Pipeline Development: Incorporating real-world safety data and alternative formulations could optimize Isovue's positioning.
• Market Expansion: Tailored marketing efforts and distributor partnerships in emerging markets can capture additional demand.
• Innovation Focus: Investing in features like reduced osmolarity forms or targeted delivery could unlock new clinical indications.

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Key Takeaways

• Robust Clinical Data: While no recent pivotal trials are underway specifically for Isovue-250, accumulating observational data and imaging advancements bolster its clinical value.
• Market Leadership: The contrast media sector remains lucrative, with Isovue holding substantial share, especially in North America.
• Growth Potential: Next-decade projections indicate sustained growth driven by demographic trends, technological innovation, and expanding healthcare infrastructure in emerging regions.
• Regulatory and Safety Vigilance: Ongoing post-marketing monitoring is vital to maintain safety standards and market trust.
• Innovation and Customization: Investment in formulation improvements and personalized dosing strategies can strengthen Isovue-250’s competitive position.

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FAQs

1. What are the primary clinical advantages of Isovue-250?
Isovue-250 offers high radiopacity, excellent tissue contrast, and a favorable safety profile, making it suitable for a variety of diagnostic imaging procedures, especially CT scans.

2. Are there recent developments in Isovue-250’s safety profile?
Post-marketing data remain positive, with hypersensitivity reactions being rare. Ongoing research aims to further mitigate nephrotoxicity, particularly in high-risk patient populations.

3. How does Isovue-250 compare competitively to other contrast agents?
It is recognized for its high efficacy and safety but faces competition from iso-osmolar agents like Visipaque, which are preferred in renal impairment cases. Market differentiation hinges on its proven reliability and versatility.

4. What emerging markets are critical for Isovue-250's growth?
Asia-Pacific, Latin America, and Eastern Europe are anticipated to experience significant growth due to infrastructural development and increasing diagnostic imaging utilization.

5. What future innovations could influence Isovue-250’s market?
Developments such as lower-osmolar formulations, targeted contrast delivery, and integration with advanced imaging technologies like dual-energy CT are poised to expand its clinical applications.

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References

1. Market Research Future. "Contrast Media Market – Forecast to 2028."
2. US Food and Drug Administration. Post-market safety updates on iodinated contrast media.
3. Clinicians and Radiologists. Recent studies on iodinated contrast agents' safety profiles.
4. Industry Reports. "Global Contrast Media Market Analysis," 2023.

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In conclusion, Isovue-250’s clinical robustness, market positioning, and future growth projections establish it as a vital component within the diagnostic imaging sector. Strategic focus on innovation, safety, and regional expansion will be essential for leveraging its market potential in the coming years.