CLINICAL TRIALS PROFILE FOR IOPAMIDOL-300

All Clinical Trials for IOPAMIDOL-300

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-300

Condition Name

Condition Name for IOPAMIDOL-300
Intervention	Trials
Coronary Artery Stenosis	3
Coronary Artery Disease	2
Diabetes Mellitus	2

Condition MeSH

Condition MeSH for IOPAMIDOL-300
Intervention	Trials
Renal Insufficiency	6
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3

Clinical Trial Locations for IOPAMIDOL-300

Trials by Country

Trials by Country for IOPAMIDOL-300
Location	Trials
United States	21
China	2
Canada	2
Italy	2
United Kingdom	1

Trials by US State

Trials by US State for IOPAMIDOL-300
Location	Trials
New Jersey	10
California	2
North Carolina	2
Illinois	2
Minnesota	2

Clinical Trial Progress for IOPAMIDOL-300

Clinical Trial Phase

Clinical Trial Phase for IOPAMIDOL-300
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for IOPAMIDOL-300
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for IOPAMIDOL-300

Sponsor Name

Sponsor Name for IOPAMIDOL-300
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

Sponsor Type for IOPAMIDOL-300
Sponsor	Trials
Industry	27
Other	23
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Iopamidol-300

Last updated: October 28, 2025

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Introduction

Iopamidol-300, a non-ionic iodinated contrast agent, plays a pivotal role in medical imaging, particularly in computed tomography (CT) diagnostics. Its high efficacy in enhancing image clarity and safety profile has cemented its presence across global radiology practices. As clinicians and investors alike monitor trends in contrast media, a comprehensive understanding of Iopamidol-300’s clinical development, market dynamics, and future projections becomes essential.

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Clinical Trials Update

Current Status and Ongoing Studies

Recent updates indicate that Iopamidol-300 continues to undergo clinical evaluations aimed at broadening its indications and affirming its safety profile. Key phases of clinical trials have focused on its use in neuroradiological imaging and various interventional procedures.

The most notable ongoing studies are:

• Phase IV Post-Marketing Surveillance: Post-approval studies assessing long-term safety and rare adverse events, involving diverse demographic cohorts globally. These studies are conducted in accordance with regulatory requirements to substantiate real-world safety profiles.

• Comparative Effectiveness Trials: Trials comparing Iopamidol-300 against other contrast agents like Iohexol and Iodixanol to establish relative benefits in specific patient populations, including those with renal impairment or allergies to other contrast media.

• Special Population Studies: Clinical validation in pediatric, geriatric, and emergency settings, aiming to refine dosing regimens and enhance safety frameworks.

Regulatory Approvals and Labeling Updates

In recent years, Iopamidol-300 has obtained additional approvals for use in specific countries, including regulatory clearances in Asia-Pacific regions, facilitated by data demonstrating comparable efficacy and safety to existing agents. Some trials have contributed to labeling updates, highlighting minimal adverse reactions and improved imaging parameters.

Future Trial Prospects

Emerging research explores the potential of Iopamidol-300 in novel imaging modalities, such as molecular imaging and combination diagnostic-therapeutic procedures (theranostics). Initiatives are underway to assess its utility in patients with compromised renal functions, leveraging low-osmolar formulations to mitigate nephrotoxicity.

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Market Analysis

Global Market Overview

The contrast media market, projected to reach US$4.2 billion by 2027 at a CAGR of approximately 5.8% (per MarketsandMarkets), reflects increasing demand driven by rising incidence of chronic diseases and expanding imaging procedures. Iopamidol-300, as a well-established non-ionic contrast agent, accounts for a significant market segment within iodine-based media.

Key Market Players

Major manufacturers include GE Healthcare, Bracco Imaging, and Bayer AG, competing on product efficacy, safety, and regional distribution networks. Bracco’s Iopamiron® series, including Iopamidol-300, maintains a steady market share owing to its proven safety profile and extensive clinical data.

Regional Market Dynamics

• North America: Dominates due to high adoption of advanced imaging and stringent regulatory standards. Two-thirds of contrast media sales occur here.
• Europe: Rapid growth driven by aging populations and increased prevalence of cardiovascular and oncological diseases.
• Asia-Pacific: Fastest-growing segment, fueled by expanding healthcare infrastructure, rising health awareness, and increasing diagnostic procedures. Notably, countries like China and India are expanding imaging capacities significantly.

Market Drivers

• Technological Advances: Improved imaging resolution with high-iodine concentration contrast agents.
• Growing Disease Burden: Cardiovascular, neurological, and oncological conditions necessitate frequent imaging.
• Regulatory Approvals: Expanded indications boost usage frequencies and market penetration.
• Safety Profile: The low osmolarity and reduced adverse effects of Iopamidol-300 appeal to clinicians, encouraging substitution of older agents.

Market Challenges

• Safety Concerns: Allergic reactions and nephrotoxicity remain risks, prompting demand for safer formulations.
• Cost Fluctuations: Raw material pricing and manufacturing costs impact profitability.
• Competition: Alternative contrast agents, including gadolinium-based and newer molecular agents, challenge Iopamidol’s market share.

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Market Projection and Future Outlook

Forecast for the Next Decade

The global Iopamidol-300 segment is anticipated to grow at a CAGR of approximately 6%, driven primarily by emerging markets as healthcare infrastructure expands. The increasing emphasis on patient safety and efficacy will sustain demand, especially as new clinical data solidify its advantages.

Innovation and R&D Trajectories

• Formulation Enhancements: Development of lower osmolality and formula modifications to further reduce adverse events.
• Personalized Imaging: Tailoring contrast doses based on patient-specific factors to optimize safety and image quality.
• Combination Modalities: Integration with emerging imaging sciences, such as dual-energy CT, to improve diagnostic precision.

Regulatory and Market Opportunities

Efforts towards broader approvals—for example, in pediatric and renal-compromised populations—offer lucrative expansion avenues. Additionally, strategic alliances and licensing agreements across emerging regions can augment market share.

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Key Takeaways

• Clinical Developments: Ongoing trials reinforce Iopamidol-300’s safety, demonstrating its vital role in complex imaging procedures and exploring expanded indications.
• Market Position: Its established efficacy, safety profile, and regional distribution strength underpin steady market demand.
• Growth Potential: The rising global burden of chronic diseases and advancements in imaging technologies suggest continued growth, especially in emerging economies.
• Challenges and Opportunities: Safety concerns necessitate continuous innovation; regulatory and market expansion remain central to maintaining competitive advantage.
• Investor and Business Strategy: Placement within comprehensive imaging portfolios and engagement in R&D collaborations can unlock future growth.

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FAQs

1. What differentiates Iopamidol-300 from other contrast agents?
Iopamidol-300 features low-osmolar, non-ionic formulation that minimizes allergic reactions and nephrotoxicity, making it safer than older ionic contrast agents.

2. Are there any recent safety concerns with Iopamidol-300?
While generally well-tolerated, rare allergic reactions and contrast-induced nephropathy have been reported, prompting ongoing surveillance and formulation improvements.

3. Which regions present the most growth opportunities for Iopamidol-300?
Asia-Pacific and Latin America are the fastest-growing markets due to expanding healthcare infrastructure and increasing diagnostic imaging procedures.

4. How might ongoing clinical trials influence Iopamidol-300’s market?
Positive trial outcomes could facilitate regulatory approvals for new indications, broadening usage and market penetration.

5. What are the key factors influencing pricing and reimbursement?
Regulatory approval status, demonstration of safety and efficacy, competitive landscape, and regional reimbursement policies primarily dictate pricing strategies.

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References

[1] MarketsandMarkets. "Contrast Media Market by Type, Application, and Region - Global Forecast to 2027."
[2] Bracco Imaging. "Iopamidol Product Data Sheets."
[3] U.S. Food and Drug Administration (FDA). "Post-Marketing Surveillance Data."
[4] European Medicines Agency (EMA). "Extended approvals for Iodinated Contrast Media."
[5] Global Industry Analysts Inc. "Medical Imaging Market Report, 2023".