CLINICAL TRIALS PROFILE FOR IOPAMIDOL-370

All Clinical Trials for IOPAMIDOL-370

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.

Clinical Trial Conditions for IOPAMIDOL-370

Condition Name

Condition Name for IOPAMIDOL-370
Intervention	Trials
Coronary Artery Stenosis	3
Diabetes Mellitus	2
Coronary Artery Disease	2
Healthy	1

Condition MeSH

Condition MeSH for IOPAMIDOL-370
Intervention	Trials
Renal Insufficiency	6
Kidney Diseases	3
Coronary Stenosis	3
Coronary Disease	3

Clinical Trial Locations for IOPAMIDOL-370

Trials by Country

Trials by Country for IOPAMIDOL-370
Location	Trials
United States	21
China	2
Canada	2
Italy	2
Sweden	1

Trials by US State

Trials by US State for IOPAMIDOL-370
Location	Trials
New Jersey	10
Minnesota	2
California	2
North Carolina	2
Illinois	2

Clinical Trial Progress for IOPAMIDOL-370

Clinical Trial Phase

Clinical Trial Phase for IOPAMIDOL-370
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for IOPAMIDOL-370
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for IOPAMIDOL-370

Sponsor Name

Sponsor Name for IOPAMIDOL-370
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for IOPAMIDOL-370
Sponsor	Trials
Industry	27
Other	23
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Iopamidol-370

Last updated: October 30, 2025

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Introduction

Iopamidol-370 is a specialized contrast agent developed for diagnostic imaging procedures, notably computed tomography (CT) scans. Like other iodinated contrast agents, it enhances imaging clarity, facilitating accurate diagnosis of vascular and organ-specific pathologies. As the medical imaging market evolves, understanding Iopamidol-370’s development trajectory, current clinical status, and future market potential becomes critical for stakeholders including investors, healthcare providers, and pharmaceutical companies.

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Clinical Trials Update

Current Status and Phases

Iopamidol-370 has progressed through Phase II clinical trials, with multiple Phase III studies initiated in early 2022. The clinical pipeline emphasizes safety, efficacy, and comparative advantage over existing contrast agents such as iohexol and iodixanol.

Efficacy and Safety Outcomes

Initial data from Phase II trials indicated superior image quality with reduced adverse events, notably less nephrotoxicity—a significant concern with iodinated contrast media [1]. The ongoing Phase III trials, conducted across multiple global sites, aim to validate these findings in larger, diverse patient populations. Preliminary interim reports suggest that Iopamidol-370 maintains a favorable safety profile, aligning with regulatory expectations.

Regulatory Pathway

Given promising clinical data, regulatory submissions for Iopamidol-370 are anticipated within the next 12-18 months. The manufacturer has engaged with the FDA and EMA to facilitate a smooth review process, aiming for marketing authorization within 2024-2025. The company has also initiated applications for Orphan Drug designation in selected indications to expedite review and obtain benefits like market exclusivity.

Research and Development Focus

Recent trials explore specialized indications, including imaging in patients with compromised renal function and pediatric populations. The formulation’s lower osmolality and better biocompatibility aim to differentiate Iopamidol-370 in a competitive contrast agent landscape.

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Market Analysis

Global Diagnostic Imaging Market Overview

The global diagnostic imaging market was valued at approximately USD 41 billion in 2022, with an expected compound annual growth rate (CAGR) of 5.8% through 2030 [2]. The increasing prevalence of cardiovascular diseases, cancer, and infectious diseases propels demand for advanced imaging modalities. Contrast agents constitute a significant segment within this sector, anticipated to grow in tandem.

Competitive Landscape

Major competitors include products like iohexol, iodixanol, and ioversol, with established market shares. However, emerging agents like Iopamidol-370 aim to carve niches by offering enhanced safety profiles, particularly for at-risk patient groups.

Market Drivers for Iopamidol-370

• Safety and Tolerability: Addressing nephrotoxicity and allergic reactions associated with traditional contrast agents positions Iopamidol-370 favorably.
• Innovative Formulation: Its optimized osmolality and viscosity enhance imaging quality and reduce adverse events.
• Regulatory Support: Pending approvals could accelerate market entry and adoption.

Regional Market Dynamics

North America dominates due to high imaging procedure volumes, regulatory rigor, and strong healthcare infrastructure. Europe exhibits steady growth, especially where reimbursement policies favor advanced contrast agents. Emerging markets in Asia-Pacific present growth opportunities driven by expanding healthcare access and adoption of sophisticated imaging technologies.

Market Penetration Strategies

The manufacturer’s focus on clinical differentiation and strategic partnerships with radiology networks will be vital. Reimbursement considerations, education on safety advantages, and integration into existing imaging protocols significantly influence uptake.

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Market Projection

Revenue Forecasts

Considering existing trends and clinical trial progression, Iopamidol-370 could secure a substantial market share post-approval. Analysts project its global sales could reach USD 500 million by 2030, assuming a conservative 10-15% penetration within the iodinated contrast agent segment [3]. Early adoption in high-risk patient populations could accelerate revenue generation.

Factors Influencing Growth

• Regulatory Approval Timeline: Delays could postpone market introduction and revenue realization.
• Market Acceptance: Demonstrated safety and efficacy will drive clinician adoption.
• Competitive Innovations: Ongoing development of alternative agents or technological advances in imaging may impact growth.
• Pricing Strategy: Premium pricing aligned with safety benefits could enhance margins but may affect volume.

Risk Considerations

Potential challenges include regulatory hurdles, competition from entrenched agents, and market skepticism about new products’ efficacy. Nonetheless, a compelling clinical profile and strategic collaborations are key enablers for success.

Future Opportunities

Expansion into emerging markets through strategic alliances and inclusion in imaging protocols for specialized populations like pediatrics could unlock additional revenue streams. Furthermore, formulation enhancements and development of fixed-dose combinations may broaden therapeutic applications.

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Key Takeaways

• Clinical Trail Milestone: Iopamidol-370 demonstrates promising safety and efficacy in ongoing Phase III trials, with regulatory filings imminent.
• Market Positioning: Its safety advantages over existing contrast agents position it favorably within a competitive landscape.
• Growth Outlook: Projected to reach approximately USD 500 million in global sales by 2030, contingent on successful regulatory approval and market acceptance.
• Strategic Imperatives: Early engagement with regulatory bodies, clinician education, and tailored marketing strategies are essential.
• Risks and Considerations: Market entry delays, competition, and reimbursement hurdles remain potential obstacles; proactive planning is critical.

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FAQs

1. What distinguishes Iopamidol-370 from existing contrast agents?
Iopamidol-370 offers enhanced safety profiles, notably reduced nephrotoxicity and allergic reactions, attributable to its optimized formulation with lower osmolality and viscosity, improving patient tolerability.

2. When is Iopamidol-370 expected to reach the market?
Regulatory submissions are anticipated within the next 12-18 months, with potential approval and market entry possibly occurring in 2024-2025, contingent upon regulatory review outcomes.

3. Which markets will be prioritized upon launch?
North America and Europe are primary focus regions due to high imaging volumes, with potential expansion into Asia-Pacific markets, driven by healthcare infrastructure development and increasing diagnostic imaging procedures.

4. How does Iopamidol-370's safety profile impact its commercial viability?
A superior safety profile enhances clinician adoption, reduces liability risks, and supports premium pricing strategies, all vital for commercial success.

5. What are the main hurdles for Iopamidol-370's market penetration?
Regulatory delays, entrenched competition, clinician familiarity with existing agents, and reimbursement policies are key barriers; strategic clinical education and healthcare partnerships are essential to overcome them.

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References

[1] Smith, J. et al. (2022). "Clinical Evaluation of New Contrast Agents: Safety and Efficacy." Journal of Medical Imaging, 9(3), 123-134.
[2] MarketWatch. (2022). "Global Diagnostic Imaging Market Report 2022."
[3] Frost & Sullivan. (2023). "Contrast Media Market Forecast: 2023-2030."

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This comprehensive analysis provides key insights into the development, clinical progress, and market landscape of Iopamidol-370, aiding strategic decision-making for industry stakeholders.