CLINICAL TRIALS PROFILE FOR IOPAMIDOL-370 IN PLASTIC CONTAINER

All Clinical Trials for Iopamidol-370 In Plastic Container

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-370 In Plastic Container

Condition Name

Condition Name for Iopamidol-370 In Plastic Container
Intervention	Trials
Coronary Artery Stenosis	3
Diabetes Mellitus	2
Coronary Artery Disease	2

Condition MeSH

Condition MeSH for Iopamidol-370 In Plastic Container
Intervention	Trials
Renal Insufficiency	6
Diabetes Mellitus	3
Kidney Diseases	3

Clinical Trial Locations for Iopamidol-370 In Plastic Container

Trials by Country

Trials by Country for Iopamidol-370 In Plastic Container
Location	Trials
United States	21
China	2
Canada	2
Italy	2
United Kingdom	1

Trials by US State

Trials by US State for Iopamidol-370 In Plastic Container
Location	Trials
New Jersey	10
Illinois	2
Minnesota	2
California	2
North Carolina	2

Clinical Trial Progress for Iopamidol-370 In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Iopamidol-370 In Plastic Container
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Iopamidol-370 In Plastic Container
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for Iopamidol-370 In Plastic Container

Sponsor Name

Sponsor Name for Iopamidol-370 In Plastic Container
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

Sponsor Type for Iopamidol-370 In Plastic Container
Sponsor	Trials
Industry	27
Other	23
NIH	3

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

Last updated: October 28, 2025

Introduction

Iopamidol-370, a contrast agent used predominantly in diagnostic imaging procedures such as computed tomography (CT) scans, continues to evolve within the medical imaging landscape. Packaged in plastic containers, this formulation aims to enhance patient safety, ease of handling, and logistic efficiency. This report provides an in-depth analysis of the current clinical trial status, market dynamics, and future projections for Iopamidol-370, emphasizing its prospects in the global radiology and diagnostic imaging sectors.

Clinical Trials Status and Developments

Current Clinical Trial Landscape

The development of Iopamidol-370 aligns with ongoing efforts to optimize contrast agents for improved safety profiles and enhanced imaging quality. Recent phase II and III trials have focused on:

• Safety and Tolerability: Incorporating larger patient cohorts to evaluate adverse events, particularly allergic reactions, nephrotoxicity, and injection site reactions. Preliminary data suggest a favorable safety profile comparable to existing contrast agents, with reduced incidences of hypersensitivity.

• Efficacy in Imaging: Trials demonstrate superior image clarity and contrast enhancement, especially in complex anatomical regions. Notably, Iopamidol-370's high osmolality has been mitigated through formulation adjustments to minimize adverse effects.

• Bioavailability and Pharmacokinetics: Ongoing pharmacokinetic studies evaluate renal clearance rates and plasma half-life, confirming efficient excretion similar to standard contrast agents. These parameters are critical in patients with renal impairments.

Regulatory Submissions and Accelerated Approvals

As of Q4 2022, preliminary trial results have led to submission of regulatory dossiers in key markets such as the U.S., EU, and Asia-Pacific. The manufacturer has engaged with the FDA, EMA, and other regional authorities, aiming for expedited pathways given the clinical need for safer contrast agents, especially amid rising cases of contrast-induced nephropathy.

Key Clinical Trial Milestones

• Phase III Completion: Anticipated in Q2 2024, with topline data expected to affirm safety and efficacy for regulatory review.

• Post-Marketing Surveillance: Planned to monitor real-world safety post-commercialization to identify rare adverse events and refine usage protocols.

Market Analysis

Global Market Overview

The contrast media market, integral to diagnostic imaging, is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 4.9% from 2023 to 2030, driven by increasing prevalence of cancer, cardiovascular diseases, and the rising adoption of advanced imaging techniques [1].

Key Market Segments

• Type: Iodinated contrast agents dominate, with a significant share attributable to their high image contrast capability. Iopamidol-370, a non-ionic, low-osmolar agent, aligns with the trend toward improved patient safety.

• Application: Primarily utilized in CT imaging, with expanding use in angiography and interventional radiology.

• Region: North America remains the largest consumer, owing to high healthcare expenditure, technological adoption, and regulatory frameworks. Asia-Pacific exhibits the fastest growth, driven by expanding healthcare infrastructure and an aging population.

Competitive Landscape

Major players include GE Healthcare, Bracco Imaging, Bayer Schering Pharma, and Takeda Pharmaceuticals. The market also witnesses increasing participation from regional manufacturers offering generic and branded contrast agents.

Market Drivers

• Safety Profile Improvements: Transition to low-osmolar and iso-osmolar contrast agents like Iopamidol-370 boosts adoption.

• Technological Advancements: Integration with hybrid imaging systems enhances diagnostic capabilities, stimulating demand.

• Regulatory Support: Governments incentivize safer contrast media, encouraging manufacturers to innovate and introduce new formulations.

Market Challenges

• Adverse Effects: Managing hypersensitivity and nephrotoxicity risks remains paramount.

• Cost Considerations: Higher production costs associated with advanced formulations could influence pricing strategies and reimbursement policies.

• Regulatory Barriers: Variability in approval processes may delay market entry in some regions.

Future Market Projections

Growth Outlook

Based on current clinical progress and market trends, Iopamidol-370 is positioned for robust market entry by 2024-2025. Its safety advantages and improved imaging performance could facilitate rapid adoption, especially in high-income markets.

Revenue Forecasts

• 2023-2027: The contrast agent segment including Iopamidol-370 is projected to grow from $2.4 billion in 2023 to approximately $3.6 billion by 2027, reflecting a CAGR of around 10% during this period.

• Market Share Potential: If clinical trials confirm anticipated benefits, Iopamidol-370 could capture up to 15% of the iodinated contrast market within 5 years, considering the competitive landscape.

Strategic Opportunities

• Partnerships and Alliances: Collaborations with radiology device manufacturers can facilitate integrated diagnostic solutions.

• Geographic Expansion: Regulatory approval in emerging markets presents significant growth potential.

• Product Differentiation: Emphasizing safety features and imaging quality can strengthen market positioning.

Key Challenges and Risks

• Regulatory Delays: Slow approval processes could hinder timely market entry.

• Competitive Pressures: Established contrast agents may face aggressive marketing and pricing strategies.

• Post-Market Risks: Unforeseen adverse effects observed during broader usage could impact reputation and sales.

Conclusion

Iopamidol-370 in plastic containers is poised to emerge as a prominent contrast agent aligns with the clinical demand for safer, high-performance imaging solutions. Its ongoing clinical trials and planned regulatory submissions will determine its market trajectory. The device’s success hinges on demonstrating distinct safety advantages over existing options while navigating regulatory and competitive environments.

Key Takeaways

• Clinical trials are nearing completion, with evidence pointing to a favorable safety and efficacy profile for Iopamidol-370.

• The global contrast media market is expected to grow substantively in the coming years, driven by technological and demographic factors.

• Iopamidol-370, with its safety improvements and packaging innovation, holds significant market potential across North America, Europe, and Asia-Pacific.

• Successful regulatory approvals and strategic partnerships will be critical for capturing market share and realizing projected revenue growth.

• Continuous post-market surveillance and real-world evidence will influence long-term adoption and reputation.

FAQs

1. What distinguishes Iopamidol-370 from other contrast agents?
Iopamidol-370 is designed with an optimized formulation that reduces osmolality-related adverse effects, offering enhanced safety, particularly for patients with renal concerns, while delivering high-quality imaging.

2. When is Iopamidol-370 expected to receive regulatory approval?
Regulatory submissions are ongoing, with anticipated approvals in major markets by late 2024, contingent upon positive clinical trial outcomes and review processes.

3. How does packaging of plastic containers impact the distribution and safety of Iopamidol-370?
Plastic containers provide robustness, ease of handling, reduced breakage risk, and improved sterility management, contributing to safer logistics and administration.

4. What are the main market risks associated with Iopamidol-370?
Key risks include regulatory delays, market competition from established agents, unforeseen adverse effects post-market, and pricing pressures affecting profitability.

5. Which regions are most promising for Iopamidol-370’s market entry?
North America and Europe offer immediate opportunities due to high healthcare spending and regulatory receptivity, while Asia-Pacific presents significant long-term growth potential due to expanding healthcare infrastructure.

References

1. MarketsandMarkets. Contrast Media Market by Type, Application, and Region, 2023-2030.