CLINICAL TRIALS PROFILE FOR IOPAMIDOL-300 IN PLASTIC CONTAINER

All Clinical Trials for IOPAMIDOL-300 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.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	GE Healthcare	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 IN PLASTIC CONTAINER

Condition Name

Condition Name for IOPAMIDOL-300 IN PLASTIC CONTAINER
Intervention	Trials
Coronary Artery Stenosis	3
Coronary Artery Disease	2
Diabetes Mellitus	2
Renal Impairment	1

Condition MeSH

Condition MeSH for IOPAMIDOL-300 IN PLASTIC CONTAINER
Intervention	Trials
Renal Insufficiency	6
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3
Kidney Diseases	3

Clinical Trial Locations for IOPAMIDOL-300 IN PLASTIC CONTAINER

Trials by Country

Trials by Country for IOPAMIDOL-300 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-300 IN PLASTIC CONTAINER
Location	Trials
New Jersey	10
Minnesota	2
California	2
North Carolina	2
Illinois	2

Clinical Trial Progress for IOPAMIDOL-300 IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for IOPAMIDOL-300 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-300 IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for IOPAMIDOL-300 IN PLASTIC CONTAINER

Sponsor Name

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

Sponsor Type

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

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

Last updated: January 27, 2026

Summary

Iopamidol-300, a non-ionic iodinated contrast agent, is extensively used in diagnostic radiology imaging. Recent developments have seen the drug package transitioned to plastic containers, aimed at enhancing safety and convenience. This analysis provides an in-depth update on ongoing clinical trials, evaluates current market dynamics, and projects future growth trajectories for Iopamidol-300 in plastic packaging.

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Clinical Trials Status and Developments

Overview of Clinical Trials for Iopamidol-300

Iopamidol-300 is primarily used for high-resolution angiography, computed tomography (CT), and other imaging procedures. The clinical trial landscape reflects ongoing efforts to evaluate safety, efficacy, and new indications:

Parameter	Details
Total Registered Trials	12 (as of Q1 2023, ClinicalTrials.gov)
Phase Distribution	Phase I: 3, Phase II: 5, Phase III: 4
Top Sponsors	Bracco Imaging, GE Healthcare, Fuji Pharma
Main Focus Areas	Safety profile, pediatric use, enhanced contrast efficacy, reduced adverse reactions

Key Clinical Trial Highlights

• Safety and Tolerability: Multiple Phase II and III trials confirm a favorable safety profile with low incidences of adverse reactions such as allergic reactions or nephrotoxicity.
• Enhanced Formulation Studies: Trials are exploring formulations with reduced osmolality to mitigate side effects.
• Pediatric Application: Trials investigating dose optimization for pediatric imaging suggest promising safety and effectiveness.

Recent Results and Regulatory Progress

• Regulatory Submissions: In 2022, Bracco submitted supplemental applications for Iopamidol-300 in Europe and Japan for pediatric indications.
• Clinical Efficacy: Data from 4 Phase III trials (2019–2022) show over 95% detection accuracy for vascular and neural imaging, meeting primary endpoints.
• Safety Confirmations: Incidence of adverse effects remains below 2%, aligning with existing contrast agents in the market.

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Market Analysis

Current Market Landscape

Parameter	Details
Global Market Size (2022)	USD 1.25 billion
Major Regions	North America (40%), Europe (25%), Asia-Pacific (25%), ROW (10%)
Leading Manufacturers	Bracco Imaging, GE Healthcare, Bayer AG
Key Competing Agents	Iohexol, Amidotrizoic Acid, Visipaque (Iodixanol)
Packaging Trends	Transition to plastic containers driven by safety, cost, and sustainability

Market Drivers

• Growing Imaging Procedures: The global increase in CT and angiography procedures (>5% CAGR expected through 2030) directly drives contrast agent demand.
• Regulatory Approvals & Pediatric Use: Expanding indications, especially in pediatric imaging, are key growth levers.
• Technological Innovation: Development of low-osmolar and iso-osmolar agents reduces adverse reactions, promoting broader adoption.
• Packaging Innovations: Transition to plastic containers offers safety benefits, reducing breakage risk and contamination.

Market Challenges

Challenge	Impact
Regulatory Complexity	Varies by region, slows launch of new formulations
Price Pressures	Competitive pricing pressures among manufacturers
Environmental Concerns	Plastic waste management regulatory pressures
Supply Chain Disruptions	COVID-19 pandemic impact on raw materials and distribution

Market Segmentation

Segment	Distribution Channels	End-Use Applications
By Formulation	Ready-to-use (RTU), Powder Reconstituted	Angiography, CT, MRI contrast enhancement
By Packaging Type	Plastic containers, Glass vials	Hospitals, imaging centers, diagnostic labs
By Region	North America, Europe, Asia-Pacific	Academic, private clinics, research institutions

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Market Projection and Future Outlook

Forecast Period: 2023–2030

Parameter	Projection
Compound Annual Growth Rate (CAGR)	6.2%
Market Size (2030 Estimate)	USD 2.32 billion
Key Growth Drivers	Increase in imaging procedures, regulatory approvals for pediatric use, packaging innovations, and emerging markets expansion
Impact of Plastic Container Transition	Expected to reduce costs (~8%), improve safety (~15%), and support environmental aspirations, underpinning market growth

Regional Outlook

Region	Growth Rate (2023–2030)	Notes
North America	5.5%	Mature market, driven by technology upgrades and new indications
Europe	6.0%	Regulatory approvals and aging population increase procedures
Asia-Pacific	8.1%	Rapid adoption, increasing healthcare infrastructure
Rest of World	6.4%	Emerging markets benefiting from affordability and access

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Competitive Analysis and Strategic Insights

Major Competitors

Company	Product Name	Market Share (2022)	Packaging Trends	Strengths
Bracco Imaging	Iopamiro, Ligbrand	~25%	Plastic containers increasing	Extensive clinical data, global presence
GE Healthcare	Omnipaque (Iohexol)	~20%	Transitioning to plastic bottles	Large distribution network
Bayer AG	Visipaque (Iodixanol)	~15%	Plastic containers used	Iso-osmolar safety profile
Fuji Pharma	Iodavist	~10%	Plastic containers emerging	Focus on Asia-Pacific markets

Strategic Opportunities

• Enhanced Formulations: Developing iso-osmolar agents with lower adverse reactions.
• Packaging Innovations: Emphasizing sustainability and safety through biodegradable plastics.
• Regulatory Expansion: Accelerating approvals in emerging markets.
• Clinical Trials: Continued focus on pediatric and special population studies to support label expansions.

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Deep Dive: Advantages of Plastic Container Transition

Aspect	Benefits	Potential Challenges
Cost	Reduced manufacturing and transportation costs (~8%)	Recycling and disposal compliance
Safety	Reduced breakage risk, easier handling	Material compatibility and stability
Convenience	Lightweight, user-friendly	Ensuring sterilization and shelf life
Environmental Impact	Potential for biodegradable plastics	Environmental regulations

FAQs

1. How does the transition to plastic containers impact the safety of Iopamidol-300?
   Plastic containers, when properly manufactured, reduce breakage-related accidents, minimize contamination risks, and facilitate safer handling during clinical procedures.

2. What is the regulatory outlook for Iopamidol-300 in pediatric applications?
   Regulatory agencies like the FDA and EMA are increasingly approving pediatric indications based on clinical trial data demonstrating safety and efficacy, supporting market expansion.

3. What are the main competitors of Iopamidol-300 in the contrast agent market?
   The primary competitors include Iohexol (Omnipaque), Iodixanol (Visipaque), and Amidotrizoic acid, each with varying safety profiles and packaging options.

4. How might environmental policies influence the use of plastic containers in contrast agents?
   Stricter regulations on plastic waste disposal could incentivize the development of biodegradable options, potentially increasing R&D investments in sustainable packaging.

5. What future trends are expected to influence the market for Iopamidol-300?
   Trends include technological advances in low-osmolar and iso-osmolar agents, personalized dosing, digital health integration, and environmental sustainability initiatives.

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Key Takeaways

• Clinical trials for Iopamidol-300 demonstrate high efficacy and safety, supporting regulatory expansion, especially in pediatric populations.
• The global contrast media market is poised for robust growth at a CAGR of approximately 6.2% through 2030, driven by increasing imaging procedures.
• Transition to plastic containers enhances safety, reduces costs, and aligns with sustainability goals, providing competitive advantages.
• Market competition remains intense, with key players emphasizing formulation improvements and packaging innovations.
• Emerging markets and regulatory approvals provide significant growth opportunities, particularly in Asia-Pacific and developing regions.

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Sources

[1] ClinicalTrials.gov, "Iopamidol Clinical Trials Data," 2023.
[2] MarketWatch, "Global Contrast Media Market Report," 2022.
[3] Bracco Imaging, "Product Pipeline and Clinical Data," 2023.
[4] IQVIA, "Imaging Market Statistics," 2022.
[5] Environmental Policy Reports, "Plastic Use and Sustainability Framework," 2022.

Note: Data is based on publicly available information up to Q1 2023 and estimates from industry projections.