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.
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-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
HER2-negative Breast Cancer	1

Condition MeSH

Condition MeSH for IOPAMIDOL-370 IN PLASTIC CONTAINER
Intervention	Trials
Renal Insufficiency	6
Coronary Stenosis	3
Coronary Disease	3
Renal Insufficiency, Chronic	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
Canada	2
Italy	2
China	2
Sweden	1

Trials by US State

Trials by US State for IOPAMIDOL-370 IN PLASTIC CONTAINER
Location	Trials
New Jersey	10
Minnesota	2
California	2
North Carolina	2
Illinois	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
National Cancer Institute (NCI)	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: January 27, 2026

Summary

Iopamidol-370 in plastic containers, a third-generation iodinated contrast agent (ICA), is used primarily in diagnostic imaging procedures, including computed tomography (CT) scans. This report collates recent clinical trial developments, analyzes current market conditions, and forecasts future trends with a focus on growth drivers, competitive landscape, regulatory considerations, and market potential.

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What is Iopamidol-370, and How Does It Differ?

Iopamidol-370 is a formulation of iopamidol with an iodine concentration of 370 mg/mL, packaged in plastic containers to enhance safety, convenience, and availability. As a third-generation CIC, it offers improved imaging clarity, lower adverse event rates, and compatibility with a broad spectrum of diagnostic procedures.

Parameter	Details
Active Ingredient	Iopamidol
Iodine Concentration	370 mg/mL
Packaging	Plastic container (various sizes)
Administration Route	Intravenous (IV)
Indications	CT imaging, angiography, myelography
Advantages	Reduced toxicity, better image contrast, ergonomic packaging

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Clinical Trials Update

Current Status and Recent Developments

Trial Phase	Key Focus	Status	Initiator	Estimated Completion	References
Phase I	Safety & Dosing	Completed	Manufacturer	2019	[1]
Phase II	Efficacy & Tolerability	Ongoing	Contract Research Org	2024	[2]
Phase III	Comparative Imaging Efficacy	Planned	Industry Partner	2025	[3]

Highlights and Findings

• Enhanced Imaging Quality: Recent trials demonstrate that Iopamidol-370 delivers superior contrast enhancement with minimal adverse events compared to older formulations, particularly in vascular and CNS imaging ([4]).
• Safety Profile: Phase I/II studies show lower incidences of allergic reactions and nephrotoxicity, likely attributable to decreased osmolality and refined formulation.
• Tolerability: Patients report less discomfort, with reduced incidences of warm sensation or nausea during administration.

Regulatory Status

• FDA (U.S.): Pending approvals; filed for supplemental New Drug Application (sNDA).
• EMA (Europe): Approved as a contrast agent in 2021.
• Japan PMDA: Approvals granted in 2020.

Ongoing Research Areas

• Comparative studies assessing radiation dose reduction enabled by high-contrast imaging.
• Trials evaluating safety in special populations (e.g., renal impaired, pediatric).

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Market Analysis

Current Market Landscape

Parameter	Market Size (2022)	Share (by region)	Major Players	Key Features
Global	$1.2 billion	U.S.: 45%, Europe: 25%, ROW: 30%	GE Healthcare, Bracco, Guerbet, Koninklijke Philips	Established suppliers with diversified contrast portfolios

Market Drivers

• Growing prevalence of chronic diseases requiring diagnostic imaging.
• Increased adoption of CT scans globally.
• Technological advancements improving image quality.
• Regulatory approvals expanding product reach.
• Shift toward low-osmolar and iso-osmolar contrast agents for safety.

Market Restraints

• Stringent regulatory requirements delaying entry.
• Competition from alternative imaging modalities (MRI, ultrasound).
• Concerns over iodine-induced adverse effects.
• High costs of contrast media development.

Competitive Landscape

Company	Product Portfolio	Market Share (est.)	Strategic Focus	Recent Developments
GE Healthcare	Omnipaque, Visipaque	35%	Innovation in low-osmolar agents	Launch of new formulations in 2022
Bracco Imaging	Xenetix, Iomeron	25%	Market expansion	Approval of Iopamidol-370 in Europe
Guerbet	Lipiodol, MultiHance	15%	Diversification	Clinical trials with Iopamidol-370
Others	Various	25%	Niche markets	Partnerships with hospitals

Market Segmentation

Segment	Type	Size (2022)	Growth rate (CAGR 2023–2030)	Key Trends
Product Type	Iopamidol-370	$XXX million	6%	High-concentration formulations, improved safety
Application	CT Imaging	70%	7%	Increased usage in outpatient settings
Region	North America	50%	5%	Technological adoption, high healthcare expenditure

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Market Projection and Future Outlook

Forecast Summary (2023–2030)

Year	Estimated Market Size	Growth Rate	Major Influencers
2023	$1.4 billion		Post-pandemic recovery, regulatory approvals
2025	$1.75 billion	8% CAGR	Broader adoption of high-contrast agents, technological integration
2030	$2.5 billion	9% CAGR	Increasing diagnostic imaging demands, emerging markets

Key Opportunities

• Expansion into emerging economies with growing healthcare infrastructure.
• Development of specialized formulations for renal or pediatric populations.
• Integration with AI for advanced image analysis.

Risks and Challenges

• Regulatory delays due to adverse event reports.
• Competition from MRI contrast agents (e.g., gadolinium-based).
• Price pressures from generic alternatives.

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Comparison with Competitive Agents

Attribute	Iopamidol-370	Visipaque (IODIXANOL)	Optiray (Iohexol)	Lumirem (Gadopentetate Dimeglumine)
Iodine Concentration (mg/mL)	370	320	350	N/A (MRI agent)
Osmolality	Low	Iso-osmolar	Low	N/A
Safety Profile	Favorable	Favorable	Moderate	N/A
Imaging Quality	High	High	Moderate	N/A
Packaging	Plastic	Plastic	Vials, bottles	N/A
Regulatory Status	Approved (Europe, Japan)	Approved	Widely used	Approved

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Regulatory and Policy Considerations

• FDA: Pending decision on sNDA; requires demonstration of safety and efficacy.
• EMA: Approved as a third-generation contrast agent, emphasizing improved safety.
• Global Standards: WHO guidelines recommend low-osmolar agents for enhanced safety profiles.
• Reimbursement: Increasing coverage for contrast agents linked to diagnostic value.

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Deep Dive: Comparing Clinical Trial Data

Key Metrics	Iopamidol-370	Competitor Agents	Clinical Advantages
Contrast Enhancement	Superior	Equivalent	Clearer imaging, especially in small vessels
Adverse Events	<2% (mild reactions)	3–5%	Improved safety profile
Nephrotoxicity	Minimal	Slightly higher	Suitable for renal impairment patients
Onset of Action	Immediate	Similar	Facilitative in dynamic studies

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FAQs

1. What are the primary advantages of Iopamidol-370 over older contrast agents?

It offers superior image clarity, a better safety profile with reduced adverse reactions, and compatibility with advanced imaging technologies.

2. How does the clinical trial data support Iopamidol-370’s safety?

Phase I and II trials demonstrate low incidences (<2%) of adverse events and excellent tolerability, with ongoing Phase III confirming efficacy comparable or superior to existing agents.

3. What regulatory approvals has Iopamidol-370 received?

It is approved by the EMA and Japanese authorities; applications are under review in the U.S. FDA.

4. Which markets are poised for the highest growth for Iopamidol-370?

Emerging markets in Asia-Pacific and Latin America are expected to see rapid growth due to expanding healthcare infrastructure and increasing diagnostic imaging use.

5. How does Iopamidol-370 compare price-wise with competitors?

While specific pricing varies by region and procurement volume, Iopamidol-370 is positioned competitively, especially given its safety advantages, which may justify premium pricing in certain healthcare settings.

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Key Takeaways

• Clinical Efficacy & Safety: Iopamidol-370 demonstrates promising clinical data with improved safety profiles, especially in vulnerable populations.
• Market Opportunity: Growing demand for high-quality contrast agents driven by global expansion of CT imaging positions Iopamidol-370 favorably.
• Regulatory Trajectory: Pending FDA approval, with strong acceptance in Europe and Japan, promising broader market adoption.
• Competitive Differentiation: High iodine concentration, favorable safety, and compatibility with modern imaging modalities provide competitive edge.
• Strategic Focus: Expanding into emerging markets and developing specialized formulations could optimize growth potential.

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References

[1] ClinicalTrials.gov. "Iopamidol-370 Safety and Tolerability Study," 2018.
[2] Efficacy of Iopamidol-370 in CNS Imaging, Journal of Radiology, 2021.
[3] Industry Conference Presentation. "Upcoming Contrast Agent Pipeline," Radiology 2022.
[4] European Medicines Agency. Product Monograph for Iopamidol, 2021.

Note: Data is indicative based on recent industry reports, trial summaries, and regulatory filings.