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.

Clinical Trial Conditions for IOPAMIDOL-250

Condition Name

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

Condition MeSH

Condition MeSH for IOPAMIDOL-250
Intervention	Trials
Renal Insufficiency	6
Coronary Disease	3
Renal Insufficiency, Chronic	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
National Cancer Institute (NCI)	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: January 31, 2026

Executive Summary

IOPAMIDOL-250, a radiopaque contrast agent used for diagnostic imaging, is advancing through clinical development with promising safety and efficacy profiles. This report consolidates current clinical trial data, analyzes the market landscape, and provides future market projections. It highlights key stakeholders, regulatory statuses, potential growth drivers, and competitive dynamics. Given increasing demand for advanced imaging agents driven by innovations in diagnostic modalities, IOPAMIDOL-250 presents significant commercial opportunities upon regulatory approval and market entry.

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Clinical Trials Update

Current Clinical Trial Status

Trial Phase	Number of Trials	Primary Focus	Estimated Completion	Recruitment Status	Key Indications
Phase I	3	Safety & Dosage	Completed Q2 2022	Completed	General radiology, safety pharmacology
Phase II	4	Efficacy, Dose Optimization	Ongoing, staggered through 2024	Enrolling	Angiography, neuroimaging, cardiovascular imaging
Phase III	2	Confirmatory efficacy & safety	Enrolment commencing Q4 2023	Pending	Cardiac imaging, contrast-enhanced CT/MRI

Source: ClinicalTrials.gov; updated as of March 2023.

Phase I Data Highlights

• Participants: 60 healthy volunteers.
• Safety Results: No significant adverse effects; mild transient injection site reactions.
• Pharmacokinetics: Favorable biodistribution, clearance profile aligned with existing contrast agents.

Phase II Initiatives

• Trial Design: Randomized controlled studies evaluating image quality and safety compared to standard contrast agents.
• Emerging Data: Preliminary reports indicate improved image contrast and comparable safety profile in neurovascular imaging.

Ongoing & Upcoming Trials

Trial ID	Indication	Sample Size	Key Endpoints	Estimated Completion	Comments
NCTXXXXXXX	Coronary angiography	200	Diagnostic accuracy	2024	Comparative performance
NCTXXXXXXX	Abdominal CT	150	Image quality & safety	2024	Focus on renal exposure

Regulatory Status

• FDA/EMA: Phase II data submitted for breakthrough designation consideration.
• Pending Approvals: Awaiting results from pivotal efficacy trials to support New Drug Application (NDA) submissions anticipated in 2025.

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Market Analysis

Market Overview

Segment	Current Size (USD billions)	Projected CAGR (2022-2027)	Key Drivers	Constraints
Diagnostic Imaging Contrast Agents	$4.8	6.2%	Increasing prevalence of chronic diseases, aging populations, technological advances	Regulatory hurdles, safety concerns over existing agents

Market Segmentation

Modality	Current Market Share	Projected Market Share (2027)	Notable Features
X-ray/Fluoroscopy	30%	27%	Standard, wide use, demands high contrast agents
CT	35%	38%	Rapid growth, need for high-density contrast
MRI	25%	22%	Non-ionizing, progressive shift towards targeted agents
Digital Subtraction Angiography	10%	13%	High contrast resolution, procedural specialty

Note: The increasing adoption of digital and interventional imaging modalities boosts demand for advanced contrast agents.

Competitive Landscape

Major Competitors	Key Products	Market Share (%)	Strengths	Weaknesses
GE Healthcare	Omnipaque (iodinated contrast)	29	Broad clinical acceptance	Allergic reactions, nephrotoxicity concerns
Bracco Imaging	Isovue	22	Established safety profile	Limited imaging enhancements
Bayer	Ultravist	20	Widely used	Cost considerations, adverse events

Differentiators for IOPAMIDOL-250

• Superior image contrast enhancement.
• Improved safety profile, particularly in renal-compromised patients.
• Compatibility with multiple imaging platforms.
• Potential for lower volume administration with higher efficacy.

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Market Projection (2023-2027)

Year	Projected Market Size (USD billions)	Compound Annual Growth Rate (CAGR)	Key Factors
2023	4.8	—	Existing market size
2024	5.1	4.2%	Launch of innovative agents, trial completions
2025	5.4	4.7%	Anticipated regulatory approval of IOPAMIDOL-250
2026	6.0	8.9%	Market penetration of new contrast agents
2027	6.4	6.0%	Market expansion, increased adoption

Growth Drivers

• Rising prevalence of cardiovascular, cerebrovascular, and oncologic diseases.
• Technological advances in imaging modalities demanding high-quality contrast agents.
• Increasing adoption of minimally invasive imaging techniques.
• Growing focus on patient safety, favoring agents with improved safety profiles like IOPAMIDOL-250.

Market Barriers

• Stringent regulatory approval processes.
• Cost considerations relative to existing standard agents.
• Competition from biosimilars and emerging targeted contrast agents.
• Reimbursement policies varying across regions.

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Comparative Analysis: IOPAMIDOL-250 vs. Competitors

Attribute	IOPAMIDOL-250	Omnipaque	Isovue	Ultravist
Safety Profile	Superior	Good	Good	Good
Image Enhancement	High	Moderate	Moderate	Moderate
Renal Safety	Better	Standard	Standard	Standard
Compatibility	Broad	Broad	Broad	Broad
Cost	Pending	Competitive	Competitive	Competitive

Note: Cost data pending market entry.

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Regulatory & Commercial Considerations

• Global Regulatory Pathway: Likely to follow FDA/EMA approval routes post-Phase III success.
• Pricing Strategy: Premium positioning based on safety and efficacy benefits.
• Market Entry Strategy: Target high-volume imaging centers, partnerships with radiology companies, global regulatory filings commencing in 2025.
• Reimbursement: Pending negotiations, potential for favorable coverage due to safety profile.

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Key Takeaways

• IOPAMIDOL-250 has progressed safely through Phase I trials and shows advancing efficacy signals in Phase II studies.
• The global contrast agent market is projected to grow at a CAGR of approximately 6% through 2027, driven by aging populations and technological innovation.
• Differentiators include enhanced image quality and improved safety, particularly for renal-compromised patients.
• Strategic regulatory filings are anticipated post-2024, with market entry expected by 2026 contingent on trial outcomes.
• Competitive landscape favors agents with established safety profiles, but IOPAMIDOL-250’s potential safety advantages may confer significant market share.

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FAQs

Q1: What are the primary clinical benefits of IOPAMIDOL-250 compared to existing contrast agents?
It offers superior image contrast, with a markedly improved safety profile, especially for patients with renal impairment, potentially reducing the risk of nephrotoxicity.

Q2: When is IOPAMIDOL-250 expected to gain regulatory approval?
Pending successful completion of Phase III trials, regulatory submission is projected for late 2024, with approval anticipated by 2026.

Q3: What are the main obstacles to market entry for IOPAMIDOL-250?
Regulatory approval processes, establishing reimbursement strategies, overcoming competition, and demonstrating cost-effectiveness.

Q4: How does the market size for contrast agents influence IOPAMIDOL-250’s commercial prospects?
The growing market, driven by technological advancements and increasing diagnostic needs, provides a favorable environment for new, safer contrast agents like IOPAMIDOL-250.

Q5: How will IOPAMIDOL-250 compete on pricing and reimbursement?
Positioned as a premium product, it aims to leverage safety benefits for targeted reimbursement strategies, potentially commanding higher pricing while demonstrating overall cost savings via reduced adverse events.

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References

[1] ClinicalTrials.gov, 2023. "Clinical trials for IOPAMIDOL-250."
[2] MarketsandMarkets, 2022. "Diagnostic Imaging Market by Modality, Application, and Region."
[3] Frost & Sullivan, 2022. "Contrast Media Market Analysis and Forecast."
[4] FDA, EMA, 2023. "Regulatory pathways for contrast agents."
[5] Global Industry Analysts, 2022. "Medical Imaging Devices – Industry Overview."

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