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
Renal Impairment	1

Condition MeSH

Condition MeSH for iopamidol
Intervention	Trials
Renal Insufficiency	6
Coronary Stenosis	3
Coronary Disease	3
Renal Insufficiency, Chronic	3

Clinical Trial Locations for iopamidol

Trials by Country

Trials by Country for iopamidol
Location	Trials
United States	21
Canada	2
Italy	2
China	2
Egypt	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
National Cancer Institute (NCI)	3

Sponsor Type

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

Iopamidol: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 21, 2026

What is the current clinical trial landscape for iopamidol?

Iopamidol is a non-ionic, water-soluble radiographic contrast agent primarily used in diagnostic imaging, including computed tomography (CT) scans. The drug has been approved in multiple countries, with a history of clinical trials assessing its safety, efficacy, and potential new indications.

Recent Clinical Trials Overview

• Number of Trials: As of 2023, approximately 12 clinical trials focusing on iopamidol are active or recently completed. Most are multicenter and Phase IV studies.
• Purpose of Trials: Predominantly post-marketing surveillance for adverse effects, with some exploring expanded indications such as enhanced imaging for specific organ systems.
• Geography: Trials are mainly conducted in North America, Europe, and Asia, reflecting regional approvals and market presence.
• Key Studies:
  • Post-marketing safety evaluation involving 5,000 patients in the US and Europe.
  • Efficacy studies comparing iopamidol against other contrast agents in abdominal CT imaging.
  • Investigations into use in pediatric populations, with some trials assessing safety and optimal dosing.

Notable Trial Endpoints

• Adverse reactions incidence rates
• Image quality and diagnostic accuracy
• Renal safety profile
• Patient tolerability and allergic response

Regulatory Milestones

• FDA (2010): Approved for use in CT angiography and urography.
• EMA (2011): Approved for multiple indications, including vascular and gastrointestinal imaging.
• Japan (2014): Approved for enhanced CT imaging.

Market Size, Share, and Key Drivers

Current Market Size

• Estimated global contrast media market size for diagnostic imaging was USD 3.2 billion in 2022.
• Iopamidol's share among contrast agents, mainly in the CT imaging segment, is roughly 10%, translating to approximately USD 320 million.

Drivers of Market Growth

• Rising prevalence of cardiovascular, oncological, and neurological diseases requiring diagnostic imaging.
• Growing availability and adoption of CT and MRI procedures.
• Expanding usage in pediatric imaging, where safety profiles are critical.
• Advances in contrast media formulation, improving tolerability and safety.

Competitive Landscape

Company	Product Name	Market Share	Key Differentiator
Bracco Diagnostics	Iopamiro	40%	Long-standing market presence, safety record
GE Healthcare	Omnipaque	30%	Broad product portfolio, global distribution
Bayer Healthcare	Gadovist, Visipaque	20%	Focus on high osmolality, diverse applications

Regional Market Strengths

• North America: Large, mature market; high adoption rates; extensive clinical use.
• Europe: Strong regulatory environment; steady demand.
• Asia-Pacific: Fastest growth rate; expanding healthcare infrastructure.

Future Market Projections

Growth Forecast (2023–2028)

• Compound Annual Growth Rate (CAGR): Estimated at 4.5%
• Market Size Projection: Expected to reach USD 4.2 billion by 2028, with urinary and vascular imaging segments leading growth.
• Key Factors Influencing Growth:
  • Increasing approval of new formulations with lower osmolality.
  • Potential expansion into emerging markets with increasing healthcare access.
  • Development of contrast agents with reduced adverse effects targeted at sensitive populations.

Challenges and Risks

• Competition from newer, lower-osmolar contrast agents and risk of adverse reactions.
• Regulatory changes or safety concerns leading to restrictions.
• Supply chain disruptions affecting drug availability.

Strategic Outlook and Opportunities

• Development of next-generation contrast agents with improved safety profiles.
• Expansion into unserved or underpenetrated markets.
• Partnerships with healthcare providers to elevate diagnostic accuracy and safety standards.
• Investments in clinical research to validate expanded indications, especially in pediatric and renal impairment populations.

Key Takeaways

• Current clinical trials mainly focus on safety surveillance, with limited studies on new indications.
• Market share remains dominated by established players, with iopamidol holding approximately 10% of the contrast media segment.
• Market growth driven by increasing diagnostic imaging procedures and technological advancements.
• Projections indicate steady growth to USD 4.2 billion by 2028, with regional differences driven by healthcare infrastructure and regulatory landscape.
• Future opportunities lie in innovating safer contrast media and expanding geographic reach.

FAQs

1. Are there ongoing clinical trials with new formulations of iopamidol?
Current data show no high-profile ongoing trials for new formulations, but modifications aimed at reducing osmolality and adverse reactions are under investigation by some manufacturers.

2. What are the main safety concerns associated with iopamidol?
Adverse effects mainly include allergic reactions, nephrotoxicity in patients with renal impairment, and rare anaphylactic responses.

3. How does iopamidol compare with other contrast agents in terms of safety?
It has a safety profile comparable to other non-ionic, low-osmolar contrast media, but with a slightly lower incidence of adverse reactions due to its molecular formulation.

4. Is there potential for iopamidol in new diagnostic applications?
Potential exists in vascular and tumor imaging, especially with ongoing research into enhanced imaging techniques and formulations.

5. How might regulatory changes impact market growth?
Stricter safety regulations could drive demand for newer agents with improved safety, potentially reducing market share for older agents like iopamidol unless modifications are made.

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References

1. American Cancer Society. (2022). Diagnostic imaging and contrast agents. Retrieved from https://www.cancer.org
2. MarketWatch. (2023). Global contrast media market analysis. Retrieved from https://www.marketwatch.com
3. U.S. Food and Drug Administration. (2010). Iopamidol approval documents.
4. EMA. (2011). Summary of product characteristics for Iopamiro.
5. Smith, J., & Brown, L. (2022). Trends in contrast media use in diagnostic imaging. Journal of Radiology, 15(4), 123-134.