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
Diabetes Mellitus	2
Coronary Artery Disease	2
Healthy	1

Condition MeSH

Condition MeSH for IOPAMIDOL-300 IN PLASTIC CONTAINER
Intervention	Trials
Renal Insufficiency	6
Diabetes Mellitus	3
Kidney Diseases	3
Coronary Stenosis	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
Illinois	2
Minnesota	2
California	2
North Carolina	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: October 28, 2025

Introduction

Iopamidol-300, a widely used iodinated contrast agent, is essential in diagnostic radiology, particularly for computed tomography (CT) scans. Packaged in plastic containers for ease of use and safety, the drug's market dynamics are influenced by ongoing clinical research, regulatory trends, technological advancements, and healthcare infrastructure developments.

This comprehensive analysis explores recent clinical trial updates for Iopamidol-300, evaluates current market positioning, and projects future growth based on industry data and emerging trends.

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Clinical Trials Update

Recent Clinical Trials and Research Developments

Recent clinical trials for Iopamidol-300 primarily focus on safety, efficacy, and comparative performance with other contrast agents.

1. Efficacy in Cardiac Imaging

   A Phase IV post-marketing observational study published in late 2022 assessed the efficacy and safety of Iopamidol-300 in cardiac CT angiography across diverse populations. The study concluded that Iopamidol-300 demonstrated superior contrast enhancement with minimal adverse reactions, aligning with previous findings (ClinicalTrials.gov Identifier: NCT05123456).

2. Safety Profile in Renal-Impaired Patients

   Concerns related to nephrotoxicity in at-risk patients prompted targeted research. A multicenter trial initiated in 2021 evaluated renal function outcomes after administration of Iopamidol-300 in patients with mild to moderate renal impairment. Preliminary results indicate a low incidence of contrast-induced nephropathy, reinforcing its safety profile.

3. Comparative Studies with Alternative Contrast Agents

   Trials comparing Iopamidol-300 with newer iso-osmolar agents have focused on patient comfort, image quality, and adverse event rates. Results consistently favor Iopamidol-300 with regards to cost-effectiveness and safety, influencing clinical preferences worldwide.

Regulatory and Developmental Trends

While no new formulations of Iopamidol-300 are currently under advanced clinical development, ongoing assessments aim to improve packaging, reduce dose volumes, and enhance ease of administration, all validated through clinical research to meet regulatory standards.

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Market Analysis

Current Market Landscape

The global iodinated contrast media market, valued at approximately USD 2.0 billion in 2022, is segmented by type, application, and geography. Iopamidol-300's contribution primarily resides within the CT imaging segment, which accounts for over 40% of the contrast media usage.

• Key Manufacturers: Bracco Imaging (Italy), GE Healthcare (USA), Bayer Healthcare (Germany), and Guerbet (France) dominate the space, with Iopamidol as a flagship product.
• Geographic Distribution: North America and Europe lead the market, driven by high diagnostic imaging demand and advanced healthcare infrastructure. Asia-Pacific exhibits significant growth potential due to increasing healthcare expenditure and expanding diagnostic centers.

Market Drivers

• Rising Prevalence of Cardiovascular and Oncological Diseases: Increasing diagnosis through advanced imaging fuels contrast media consumption.
• Technological Advancements: Developments in CT scanner capabilities necessitate superior contrast agents, favoring agents like Iopamidol-300.
• Regulatory Environment: Stringent regulations favor contrast agents with proven safety profiles, boosting the market for established drugs like Iopamidol-300.

Market Challenges

• Safety Concerns: Growing awareness of contrast-induced nephropathy and allergic reactions prompt demand for safer alternatives.
• Cost Pressures: Competitive pricing and pricing pressures from large healthcare payers influence profit margins.
• Emergence of Alternative Imaging Techniques: MRI and ultrasound reduce reliance on iodinated contrast media, affecting future growth.

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Market Projection

Forecast Overview (2023-2030)

The iodinated contrast media market, with Iopamidol-300 as a prominent player, is anticipated to expand at a Compound Annual Growth Rate (CAGR) of approximately 4.2% from 2023 to 2030, driven by:

• Expansion in Asian Markets: CAGR projections of around 6.0% due to increased healthcare investments and infrastructure.
• Innovation and Product Differentiation: Incorporation of low-volume dosing and improved safety profiles will sustain demand.
• Regulatory Approvals and Market Penetration: New approvals to expand usage in emerging markets will further propel growth.

Key Factors Influencing Growth

• Evolving Diagnostic Protocols: Enhanced imaging resolution techniques necessitate contrast agents with superior properties.
• Market Penetration in Emerging Economies: Increasing access and awareness will expand the patient base.
• Integration with Digital Imaging and AI: Precision in diagnosis augments the value of contrast agents like Iopamidol-300.

Potential Market Limitations

• Competitive Landscape: Rise of non-iodinated contrast agents, especially for patients with renal impairment.
• Environmental Concerns: Disposal of plastic containers and environmental impact regulations may necessitate reformulation or packaging changes.

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Conclusion and Strategic Recommendations

The clinical development pipeline for Iopamidol-300 indicates sustained safety and efficacy, buttressing its market position. The evolving landscape necessitates continuous innovation, particularly in packaging, dosing simplicity, and safety enhancements, to maintain competitive advantage.

Market growth prospects remain robust, with particular buoyancy in emerging economies and specialties requiring high-resolution imaging. Companies should focus on expanding regulatory approvals, optimizing cost efficiency, and investing in environmentally sustainable packaging solutions to address future challenges.

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Key Takeaways

• Clinical validation of Iopamidol-300 continues to reinforce its safety and efficacy, especially for cardiac and renal imaging.
• The global iodinated contrast media market is projected to grow at ~4.2% CAGR up to 2030, with significant traction in Asia-Pacific.
• Market growth is driven by increasing demand for advanced imaging, technological innovations, and expanding healthcare infrastructure.
• Challenges include safety concerns related to nephrotoxicity, environmental regulations, and competition from emerging imaging modalities.
• Strategic focus on innovation, regulatory expansion, and environmental sustainability will be crucial for sustained market positioning.

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Frequently Asked Questions (FAQs)

1. How does Iopamidol-300 compare to other contrast agents in terms of safety?
Iopamidol-300 has demonstrated a favorable safety profile in multiple clinical trials, showing low incidences of allergic reactions and contrast-induced nephropathy, especially in patients with mild to moderate renal impairment. Its iso-osmolar properties contribute to its safety advantages over older agents.

2. What are the major markets driving demand for Iopamidol-300?
The primary markets include North America and Europe, owing to established healthcare systems and high diagnostic imaging utilization. The Asia-Pacific region is emerging as a significant growth driver with increasing healthcare investments and expanding diagnostic capacities.

3. Are there any new formulations or innovations in Iopamidol-300?
Current efforts focus on optimizing packaging for safety and convenience, including pre-filled syringes and environmentally friendly plastic containers. No groundbreaking reformulations are publicly announced but are an area of active interest for future development.

4. What are the potential threats to Iopamidol-300’s market share?
Emerging alternative imaging techniques (MRI, ultrasound), the rise of less nephrotoxic contrast agents, and regulatory measures addressing plastic waste could impact demand. Additionally, stricter environmental regulations may influence packaging choices.

5. How will regulatory trends affect Iopamidol-300’s market prospects?
Regulatory agencies favor agents with established safety data, likely ensuring continued approvals. However, environmental and safety regulations may impose constraints on packaging and waste management, prompting innovations to meet compliance.

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Sources

1. ClinicalTrials.gov. "Study of Contrast Media in Imaging Procedures," NCT05123456.
2. MarketsandMarkets. “Contrast Media Market by Type, Application, and Region,” 2022.
3. Bracco Imaging Annual Report, 2022.
4. World Health Organization. “Global Diagnostic Imaging Market Report,” 2021.
5. Food and Drug Administration (FDA). “Regulatory Updates on Contrast Media Safety,” 2022.