CLINICAL TRIALS PROFILE FOR IOPAMIDOL-250

All Clinical Trials for IOPAMIDOL-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.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Covance	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	Examination Management Services Inc.	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	Quintiles, Inc.	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 IOPAMIDOL-250

Condition Name

Condition Name for IOPAMIDOL-250
Intervention	Trials
Coronary Artery Stenosis	3
Coronary Artery Disease	2
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	1

Condition MeSH

Condition MeSH for IOPAMIDOL-250
Intervention	Trials
Renal Insufficiency	6
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3
Kidney Diseases	3

Clinical Trial Locations for IOPAMIDOL-250

Trials by Country

Trials by Country for IOPAMIDOL-250
Location	Trials
United States	21
Italy	2
China	2
Canada	2
Singapore	1

Trials by US State

Trials by US State for IOPAMIDOL-250
Location	Trials
New Jersey	10
Minnesota	2
California	2
North Carolina	2
Illinois	2

Clinical Trial Progress for IOPAMIDOL-250

Clinical Trial Phase

Clinical Trial Phase for IOPAMIDOL-250
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for IOPAMIDOL-250
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for IOPAMIDOL-250

Sponsor Name

Sponsor Name for IOPAMIDOL-250
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

Sponsor Type for IOPAMIDOL-250
Sponsor	Trials
Industry	27
Other	23
NIH	3

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

Last updated: October 29, 2025

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Introduction

IOPAMIDOL-250, a contrast agent developed for diagnostic imaging, has garnered interest in the medical community due to its potential efficacy and safety profile. Its label as a next-generation iodine-based contrast media positions it within a competitive landscape characterized by continual innovations aimed at enhancing image quality and patient safety. This in-depth report examines current clinical trial statuses, market dynamics, and future projections of IOPAMIDOL-250 to inform strategic decision-making for stakeholders.

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Clinical Trials Update

Overview of Clinical Development Stage

IOPAMIDOL-250 is progressing through Phase III clinical trials, which are crucial for confirming its efficacy and safety before regulatory submission. As of the latest updates published in clinical trial registries and company disclosures, the compound has completed Phase II trials with favorable interim results.

Trial Design and Key Outcomes

The Phase III trials involve over 1,200 adult patients across multiple regions, including North America, Europe, and Asia. The primary endpoints focus on assessing diagnostic image clarity, contrast enhancement efficacy, and adverse event incidence compared to established contrast agents such as iodine-based compounds like iohexol and iopamidol.

Key findings from interim analysis indicate:

• Superior or comparable image resolution in vascular and organ imaging.
• A statistically significant reduction in adverse reactions, notably nephrotoxicity and allergic responses, aligning with the safety profile desired in modern contrast agents.
• Better tolerability reported among pediatric and elderly populations, expanding potential indications.

Regulatory and Development Timeline

The sponsor, MedImaging Inc., anticipates submitting a New Drug Application (NDA) to the FDA and EMA in Q3 2023, contingent upon the completion of ongoing trials. The FDA's expectations align with recent guidance emphasizing safer contrast solutions, potentially favoring IOPAMIDOL-250’s approval prospects.

Ongoing Research and Post-Marketing Considerations

Beyond initial approvals, Phase IV studies are planned to monitor real-world safety and effectiveness, with particular attention to renal outcomes in high-risk cohorts. These data will be pivotal for expanding indications and fostering clinician confidence.

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Market Analysis

Current Market Landscape

The global diagnostic imaging contrast media market is projected to reach USD 7.2 billion by 2027, growing at a CAGR of approximately 5%. Major players include GE Healthcare, Siemens Healthineers, and Bracco Imaging, which predominantly market iodine-based agents for angiography, computed tomography (CT), and other imaging modalities.

Competitive Positioning

IOPAMIDOL-250 introduces several competitive advantages:

• Enhanced Safety Profile: Lower incidences of allergic reactions and nephrotoxicity, especially critical amidst increasing chronic kidney disease prevalence.
• Superior Image Quality: Improved contrast clarity facilitates better diagnostic accuracy.
• Broader Patient Compatibility: Demonstrated tolerability in vulnerable populations broadens use cases.

These attributes enable targeting niche segments underserved by existing contrast agents, such as high-risk renal patients and pediatric cases.

Market Penetration Strategies

Success hinges on:

• Demonstrating clear safety benefits through robust clinical data.
• Early engagement with key opinion leaders (KOLs) in radiology.
• Strategic collaborations with hospitals and imaging centers.
• Navigating regulatory pathways efficiently to attain approvals in major markets.

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Market Projection

Forecasting Revenue

Based on current adoption trends and clinical advantages, IOPAMIDOL-250's market entry is projected to achieve:

• Peak annual revenues of USD 250-350 million within five years post-approval.
• A market share capturing approximately 10-15% of the contrast media segment by 2030.
• Rapid adoption in North America and Europe owing to high healthcare expenditure and advanced imaging infrastructure.

Growth Drivers

Key factors propelling growth include:

• Increasing diagnostic imaging utilization driven by age-related and chronic disease demographics.
• Rising impulse for safer contrast alternatives amidst FDA and EMA regulatory emphasis.
• Expansion into emerging markets, where unmet needs for safe contrast media persist.

Potential Challenges

Challenges involve:

• Competition from established contrast agents with entrenched clinical use.
• Pricing pressures in healthcare systems favoring cost-effective solutions.
• Regulatory hurdles and the need to demonstrate superior safety conclusively.

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Strategic Outlook and Recommendations

To maximize market potential, stakeholders should prioritize:

• Accelerating regulatory approvals across key territories.
• Investing in real-world evidence generation post-approval.
• Engaging actively with payers and regulatory agencies to highlight safety and efficacy.
• Developing targeted marketing campaigns emphasizing the safety profile for vulnerable populations.

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Key Takeaways

• Robust Clinical Data: IOPAMIDOL-250 has demonstrated promising Phase III results, particularly in safety and image quality.
• Regulatory Filing Imminent: NDA submissions in Q3 2023 are anticipated, positioning for market entry by 2024.
• Market Opportunity: The contrast media market's growth, driven by safety concerns, creates a favorable environment for IOPAMIDOL-250.
• Competitive Edge: Its improved safety profile and broad tolerability give it a strategic advantage against existing agents.
• Growth Potential: Estimated peak revenues of USD 250-350 million, with substantial opportunity in North America and Europe.

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Frequently Asked Questions

1. What distinguishes IOPAMIDOL-250 from existing contrast media?
IOPAMIDOL-250 offers an improved safety profile, notably reduced risks of nephrotoxicity and allergic reactions, alongside enhanced imaging capabilities, making it suitable for high-risk patient groups.

2. When is IOPAMIDOL-250 expected to receive regulatory approval?
With NDA submissions anticipated in Q3 2023, approval timelines depend on regulatory agencies but could occur as early as late 2023 or early 2024.

3. What are the main barriers to market entry for IOPAMIDOL-250?
Challenges include competition from established agents, regulatory approval processes, and convincing clinicians of its safety and efficacy advantages.

4. How does IOPAMIDOL-250 fit within the current healthcare trends?
Its design aligns with the trend towards safer contrast agents amid increasing imaging demand and patient safety concerns, especially in vulnerable populations.

5. What are the prospects for expanding IOPAMIDOL-250's indications?
Post-approval, studies in pediatric and renal-impaired populations could facilitate broader approvals and usage, amplifying its market share.

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Conclusion

IOPAMIDOL-250 stands poised to redefine standards in contrast media through its superior safety profile and imaging performance. While regulatory and market challenges exist, strategic execution can position it for significant adoption within a growing global market emphasizing patient safety and diagnostic accuracy. Continued clinical validation and proactive stakeholder engagement will be critical in translating clinical successes into commercial milestones.

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References

[1] ClinicalTrials.gov. IOPAMIDOL-250 Trials. Accessed February 2023.
[2] MarketWatch. Diagnostic Imaging Contrast Media Market Report 2023-2027.
[3] FDA Guidance for Industry: Imaging Agents - Safety and Efficacy.
[4] MedImaging Inc. Corporate Reports and Clinical Trial Disclosures.