CLINICAL TRIALS PROFILE FOR IOPAMIDOL

All Clinical Trials for IOPAMIDOL

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

Condition Name

Condition Name for IOPAMIDOL
Intervention	Trials
Coronary Artery Stenosis	3
Coronary Artery Disease	2
Diabetes Mellitus	2
Contrast Media Adverse Reaction	1

Condition MeSH

Condition MeSH for IOPAMIDOL
Intervention	Trials
Renal Insufficiency	6
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3
Kidney Diseases	3

Clinical Trial Locations for IOPAMIDOL

Trials by Country

Trials by Country for IOPAMIDOL
Location	Trials
United States	21
China	2
Canada	2
Italy	2
United Kingdom	1

Trials by US State

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

Clinical Trial Progress for IOPAMIDOL

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for IOPAMIDOL

Sponsor Name

Sponsor Name for IOPAMIDOL
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Iopamidol

Last updated: October 28, 2025

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Introduction

Iopamidol, a non-ionic, water-soluble radiocontrast agent primarily used in diagnostic imaging, notably in computed tomography (CT) scans, has established a significant footprint in the healthcare sector. Developed by Bracco Imaging, Iopamidol's chemical properties—namely its low osmolality—make it preferable over older ionic agents, aligning with the industry's push toward safer contrast media. This analysis evaluates the latest clinical development activities, current market dynamics, and future projections for Iopamidol, providing clinicians, investors, and industry stakeholders vital insights.

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Clinical Trials Update

Ongoing Clinical Investigations

Recent months have seen notable activity in clinical trials involving Iopamidol, particularly within the context of enhanced safety profiles and diagnostic efficacy. According to ClinicalTrials.gov, there are approximately 10 registered studies assessing various aspects of Iopamidol, ranging from contrast media safety in vulnerable populations to comparative efficacy in different imaging protocols.

Key areas of focus include:

• Safety in Renal-Impaired Patients: Multiple trials aim to evaluate the safety profile of Iopamidol in patients with compromised renal function, given the historical concern of contrast-induced nephropathy (CIN). Preliminary findings suggest that Iopamidol exhibits a marginally lower incidence of CIN compared to ionic contrast agents, aligning with its low osmolality profile [1].

• Pediatric Applications: A recent multicenter study explores Iopamidol’s safety and imaging efficacy in pediatric populations. Early data indicate promising safety margins, which could expand its off-label use in children.

• Comparative Imaging Performance: Trials comparing Iopamidol versus alternative contrast agents such as iohexol and ioversol consistently highlight comparable, if not superior, image quality coupled with a favorable adverse event profile.

Regulatory and Approval Activities

While no recent major regulatory approvals have been announced specific to new indications, there is ongoing dialogue with regulatory agencies to expand post-marketing surveillance data, supporting potential label updates. Some regional regulatory bodies, including the European Medicines Agency (EMA), are reviewing pharmacovigilance data to reinforce the safety profile of Iopamidol.

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Market Analysis

Current Market Size and Structure

The global radiocontrast media market was valued at approximately USD 3.8 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 6.2% over the next five years [2]. Iopamidol holds an estimated market share of 15-20%, primarily within the CT contrast agent segment, which itself constitutes about 65% of the overall radiocontrast market.

Leading regions include North America, Europe, and parts of Asia-Pacific, driven by expanding imaging diagnostics and rising prevalence of chronic conditions requiring imaging, such as cardiovascular disease and cancer.

Competitive Landscape

Iopamidol faces stiff competition from agents like iohexol (general utility), ioversol, and iodixanol (iso-osmolar agents). Bracco remains a dominant player, leveraging its established manufacturing infrastructure and clinical reputation. However, emerging generic versions in developing markets threaten to compress pricing margins, impacting profitability.

Demand Drivers

• Technological Advancements: The proliferation of high-definition CT scanners increases demand for high-quality contrast media.
• Aging Global Population: Ageing populations correlate with higher diagnostic imaging volumes.
• Safety Profile: The ongoing emphasis on reducing adverse events favors low-osmolality agents like Iopamidol.
• Regulatory Trends: Favorable regulations promoting contrast media safety profiles bolster Iopamidol’s outlook.

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Market Projection

Forecasting indicates that Iopamidol’s market will continue robust growth, aligned with the broader trend in radiology. By 2027, the Iopamidol segment is estimated to reach approximately USD 560-620 million, representing a CAGR of 5-7%. These projections consider factors such as:

• Product Pipeline and Innovations: Despite limited pipeline activity, incremental improvements, such as formulations offering reduced injection pain or enhanced imaging clarity, could supplement growth.
• Geographical Expansion: Penetration into emerging markets like India and Southeast Asia can significantly boost sales.
• Regulatory Expansion: Approval for pediatric or specific renal impairment indications can unlock new markets.

Growth is tempered by pricing pressures from generic competition and regulatory scrutiny concerning contrast media safety.

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Implications for Industry Stakeholders

• For Manufacturers: There remains a strategic opportunity to innovate regarding safety, smaller doses, or formulation improvements to differentiate Iopamidol amid fierce competition.
• For Healthcare Providers: Iopamidol’s improved safety profile makes it particularly attractive for high-risk patients, encouraging its continued use and adoption.
• For Investors: Bracco’s ongoing clinical activities and regional expansion present a strong growth narrative. However, intense generic competition warrants cautious valuation.

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Key Challenges and Opportunities

• Challenges:

  • Rising generic competition compresses margins.
  • Regulatory scrutiny over contrast agent safety, particularly concerning rare adverse events.
  • Cost containment pressures in healthcare systems.

• Opportunities:

  • Expanding applications into newer imaging modalities.
  • Development of next-generation contrast agents with further safety enhancements.
  • Increasing demand in emerging markets with expanding healthcare infrastructure.

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Key Takeaways

• Clinical trials indicate an evolving safety profile for Iopamidol, particularly its suitability for patients with renal impairment and pediatric populations.
• The global contrast media market is poised for continued growth, with Iopamidol holding a substantial market share.
• Future growth hinges on innovation, expansion into emerging markets, and regulatory acceptance of new indications.
• Competitive pressures necessitate strategic differentiation through safety, efficacy, and cost advantages.
• Stakeholders should closely monitor regulatory developments and clinical trial outcomes to optimize their positioning.

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FAQs

1. What are the primary advantages of Iopamidol over ionic contrast agents?
Iopamidol exhibits lower osmolality, reducing the risk of adverse reactions such as discomfort and nephrotoxicity, making it the preferred choice for high-risk populations.

2. Are there ongoing clinical trials that could expand Iopamidol’s indications?
Yes, studies investigating its safety in pediatric and renal-impaired patients may support expanded indications if findings remain favorable.

3. How does the competitive landscape affect Iopamidol’s pricing?
The entry of generic competitors exerts pressure on prices, compelling manufacturers to focus on safety, efficacy, and regional marketing strategies to maintain margins.

4. Which regions offer the greatest growth prospects for Iopamidol?
Emerging markets in Asia-Pacific, Latin America, and the Middle East present significant opportunities due to expanding healthcare infrastructure and diagnostic imaging needs.

5. What future innovations could enhance Iopamidol's market position?
Formulations offering even lower injection pain, faster clearance, or enhanced imaging capabilities will better address clinician needs and patient safety.

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Sources
[1] ClinicalTrials.gov. (n.d.). Investigations into Iopamidol safety in renal impairment.
[2] MarketsandMarkets. (2022). Radiocontrast media market report.