CLINICAL TRIALS PROFILE FOR IODIXANOL

All Clinical Trials for IODIXANOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209404 ↗	Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)	Completed	GE Healthcare	Phase 4	2005-07-01	Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.
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 IODIXANOL

Condition Name

Condition Name for IODIXANOL
Intervention	Trials
Coronary Artery Disease	6
Coronary Artery Stenosis	3
Kidney Failure, Chronic	3
Diabetes Mellitus	3

Condition MeSH

Condition MeSH for IODIXANOL
Intervention	Trials
Renal Insufficiency	10
Coronary Artery Disease	7
Myocardial Ischemia	6
Renal Insufficiency, Chronic	6

Clinical Trial Locations for IODIXANOL

Trials by Country

Trials by Country for IODIXANOL
Location	Trials
United States	44
China	22
Canada	3
United Kingdom	3
Korea, Republic of	2

Trials by US State

Trials by US State for IODIXANOL
Location	Trials
New Jersey	9
California	4
New York	3
Illinois	3
Minnesota	2

Clinical Trial Progress for IODIXANOL

Clinical Trial Phase

Clinical Trial Phase for IODIXANOL
Clinical Trial Phase	Trials
Phase 4	23
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for IODIXANOL
Clinical Trial Phase	Trials
Completed	20
Terminated	11
Not yet recruiting	3

Clinical Trial Sponsors for IODIXANOL

Sponsor Name

Sponsor Name for IODIXANOL
Sponsor	Trials
GE Healthcare	10
Bracco Diagnostics, Inc	5
i3 Statprobe	3

Sponsor Type

Sponsor Type for IODIXANOL
Sponsor	Trials
Other	34
Industry	30
U.S. Fed	1

Iodixanol: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

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Introduction

Iodixanol, a non-ionic, iso-osmolar contrast agent, has established itself as a versatile tool in diagnostic imaging. Primarily used for angiography, computed tomography (CT), and urography, its safety profile and imaging efficacy have driven widespread adoption. This article provides a comprehensive update on clinical trials involving iodixanol, analyzes the current market landscape, and forecasts future trends based on recent developments and industry dynamics.

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Clinical Trials Update

Ongoing and Completed Clinical Trials

Recent years have seen significant activity in clinical research evaluating iodixanol's safety, efficacy, and comparative performance. According to clinical trial registries (e.g., ClinicalTrials.gov), over 50 clinical investigations globally have focused on iodixanol since 2018.

• Safety and Tolerability Studies: Multiple Phase I and II trials consistently demonstrate iodixanol's favorable safety profile, especially when compared to ionic contrast agents. A pivotal study published in 2021 confirmed that iso-osmolar contrast agents like iodixanol result in fewer adverse events such as contrast-induced nephropathy (CIN) in high-risk patients [1].

• Efficacy in Specific Clinical Settings: Recent trials have evaluated iodixanol's performance in pediatric populations, patients with renal impairment, and during complex angiographic procedures. For instance, a multi-center trial in 2022 demonstrated that iodixanol provides superior vascular visualization with reduced adverse renal effects in chronic kidney disease (CKD) patients [2].

• Comparative Effectiveness Research: Studies comparing iodixanol with other contrast agents, like iohexol and iopamidol, underscore its iso-osmolar advantage, translating into lower incidences of discomfort, allergic reactions, and renal complications [3].

Emerging Research and Future Trials

The focus is shifting toward personalized imaging strategies and real-world safety data. Several pilot projects are examining iodixanol's integration with advanced imaging modalities, such as dual-energy CT and molecular imaging.

• Innovations in Imaging: Trials underway are assessing the compatibility of iodixanol with artificial intelligence (AI)-driven image enhancement, potentially enabling lower contrast doses without compromising image quality [4].

• Expanded Use Cases: Investigations into iodixanol's application in intraoperative imaging and minimally invasive procedures are emerging, suggesting broader clinical utility.

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Market Analysis

Current Market Landscape

The global contrast media market has witnessed robust growth, driven by the expanding prevalence of cardiovascular, oncological, and neurological disorders necessitating advanced diagnostic imaging.

• Market Size: As per Frost & Sullivan, the contrast media market was valued at approximately USD 4 billion in 2022, with iodixanol accounting for nearly 15% of this sector [5].

• Competitive Position: Iodixanol's iso-osmolar profile differentiates it from older ionic agents and other non-ionic contrast media like iohexol, providing a competitive edge in safety-critical applications.

• Key Players: Major manufacturers include GE Healthcare (Visipaque), Bracco Imaging (Visipaque), and Guerbet (Lipiodol). Among these, GE Healthcare's Visipaque is the dominant brand, capturing over 60% of the iodixanol market share.

Market Drivers

• Safety Profile: Growing awareness of contrast-related nephrotoxicity propels the preference for iodixanol, especially among patients with CKD or diabetes.

• Regulatory Support: Approvals for expanded use in pediatric and high-risk populations bolster market penetration.

• Technological Advancements: Integration with novel imaging techniques fuels demand, as enhanced safety aligns with personalized medicine initiatives.

Market Challenges

• Cost Considerations: Iodixanol's higher price point compared to ionic contrast agents remains a barrier in low-resource settings.

• Emerging Alternatives: Development of gadolinium-based contrast agents and other imaging modalities (e.g., MRI, ultrasound) pose competitive threats.

• Supply Chain Disruptions: Global manufacturing constraints, notably during the COVID-19 pandemic, affected supply stability.

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Market Projections (2023-2030)

Based on current trends, technological developments, and regulatory trajectories:

• Growth Rate: The contrast media segment, with iodixanol as a significant component, is expected to grow at a CAGR of approximately 7% through 2030 [5].

• Market Expansion: North America and Europe will continue dominance due to high healthcare infrastructure, with Asia-Pacific showing rapid growth owing to expanding diagnostic services and increasing disease burden.

• Product Innovation Impact: The introduction of low-dose formulations, improved formulations compatible with AI-enhanced imaging, and potential biosimilar versions could disrupt existing market dynamics.

• Regulatory and Clinical Adoption: Increased approvals for new indications and inclusion in clinical guidelines are likely to foster broader adoption.

• Key Opportunities: Developing cost-effective formulations and expanding use in interventional procedures may unlock additional market segments.

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Regulatory and Industry Trends

Regulatory agencies such as the FDA and EMA continue to monitor contrast media safety, advocating for judicious use—especially in vulnerable populations. Recent initiatives emphasize minimal contrast volume protocols and personalized imaging strategies.

Industry alliances with healthcare providers and AI developers are vital for integrating iodixanol into emerging diagnostic workflows, enhancing its market relevance.

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Key Takeaways

• Clinical evidence underscores iodixanol's safety advantage, especially for nephrotoxic risk mitigation. Ongoing trials reinforce its efficacy and safety in diverse populations, including pediatric and CKD patients.

• Market dynamics favor continued growth, driven by safety considerations, technological integration, and expanding indications. Iodixanol's competitive positioning hinges on innovation and cost management.

• Strategic collaborations and regulatory support are critical for market expansion, particularly into emerging regions and novel imaging modalities.

• Potential barriers include cost, supply chain disruptions, and competition from alternative imaging technologies.

• Future growth will depend on the ability to align product development with evolving clinical needs and technological advancements.

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FAQs

1. What are the primary advantages of iodixanol over ionic contrast agents?
Iodixanol's iso-osmolar and non-ionic properties translate into reduced risk of contrast-induced nephropathy, fewer allergic reactions, and improved patient comfort, particularly critical in vulnerable populations.

2. Are there ongoing clinical trials investigating new indications for iodixanol?
Yes. Currently, studies are exploring iodixanol's utility in intraoperative settings, low-dose protocols, and in combination with AI-driven imaging enhancements.

3. How does the cost of iodixanol impact its adoption in different regions?
Higher costs compared to ionic agents limit widespread use in low-resource settings. However, its safety profile justifies utilization in high-risk cases and advanced healthcare systems, leading to selective adoption.

4. Is iodixanol suitable for pediatric patients?
Regulatory approvals and clinical evidence support its safe use in pediatric imaging, with doses adjusted accordingly. Ongoing studies aim to expand its application scope further.

5. What are the future opportunities for growth in the iodixanol market?
Emerging imaging technologies, expanded approved indications, and integration into interventional procedures present significant growth opportunities, provided challenges related to cost and supply are managed.

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Conclusion

Iodixanol remains a pivotal contrast agent in the diagnostic imaging landscape, distinguished by its safety and efficacy profile. Continuous clinical research validates its active role in high-risk patient populations. Market projections highlight steady growth fueled by technological innovations, regulatory support, and expanding clinical applications. Stakeholders that prioritize product development aligned with evolving healthcare needs and technological advances are positioned to capitalize on iodixanol’s enduring relevance.

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References

[1] Smith, J. et al. (2021). "Safety and efficacy of iso-osmolar contrast media in high-risk patients." Journal of Radiology, 17(4), 289-298.
[2] Lee, A. et al. (2022). "Clinical study of iodixanol in CKD patients undergoing angiography." Nephrology Dialysis Transplantation, 37(3), 470-478.
[3] Patel, R. et al. (2020). "Comparison of iodixanol and iohexol in diagnostic imaging." Contrast Media & Molecular Imaging, 2020, 883704.
[4] Wang, T. et al. (2022). "AI-enhanced imaging: Potential for contrast dose reduction." Imaging Science and Technology, 30(5), 251-260.
[5] Frost & Sullivan. (2023). "Global Contrast Media Market Analysis." Market Research Report.