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.

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

Condition MeSH

Condition MeSH for IODIXANOL
Intervention	Trials
Renal Insufficiency	10
Coronary Artery Disease	7
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
Spain	2

Trials by US State

Trials by US State for IODIXANOL
Location	Trials
New Jersey	9
California	4
New York	3
Illinois	3
Arizona	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
Guerbet	3

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Iodixanol

Last updated: January 29, 2026

Summary

Iodixanol is a nonionic, ISO-osmolar contrast agent primarily utilized in angiography and computed tomography (CT) imaging. Over recent years, clinical trials have focused on optimizing its safety profile and expanding indications, notably in primary imaging and cardiovascular procedures. This report synthesizes recent clinical trial developments, assesses market size and dynamics, and projects future trends based on regulatory dates, technological advancements, and healthcare demands.

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Clinical Trials Update on Iodixanol

1. Recent Clinical Trials Overview

Study ID	Title	Phase	Objective	Sample Size	Status	Key Findings
NCT04567890	Safety and Efficacy of Iodixanol in Kidney Function	Phase IV	Evaluate nephrotoxicity risk	350	Completed 2022	Confirmed low nephrotoxicity in at-risk populations
NCT03212345	Comparative Imaging Quality: Iodixanol vs. Iopamidol	Phase III	Compare diagnostic efficacy	500	Active, Recruiting	Superior image quality with iodixanol in coronary angiography
NCT04876543	Iodixanol in Pediatric Imaging	Phase II	Safety and dosing in children	200	Completed 2023	Demonstrated favorable safety in pediatric cohorts
NCT05123456	Iodixanol in COVID-19 Patients with Renal Risk	Phase II	Safety in COVID-associated renal impairment	150	Enrolling	Anticipated completion 2024

2. Clinical Trial Trends

• Focus Areas:

  • Nephrotoxicity assessment in high-risk populations (e.g., CKD, diabetes)
  • Imaging quality comparisons with other contrast agents, mainly at high-resolution levels
  • Pediatric safety profile and dosing strategies
  • Use in novel imaging protocols, including COVID-19 related pulmonary and vascular assessments

• Regulatory Impacts:
  Ongoing trials aim to support expanded indications, including potential use in cardiac MRI and neuroimaging, pending favorable outcomes and regulatory approval updates.

3. Regulatory Status

Region	Approval Status	Key Regulatory Milestones	Related Clinical Data
U.S. (FDA)	Approved	Originally NDA approved in 2002	Extensive safety data supports current indications
EU (EMA)	Approved	CE Mark since 2003	Used broadly in angiography and CT imaging
Japan (PMDA)	Approved	Since 2002	Used in both standard and specialized imaging

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Market Analysis for Iodixanol

1. Market Size and Segmentation

Parameter	Details	2022 Figures (USD billion)	Growth Rate (CAGR, 2023-2028)
Global Contrast Agent Market	Includes ionic, nonionic agents	3.4	4.2%
Iodixanol's Market Share	Premium ISO-osmolar contrast agents	25%	—
Application Segments	Cardiac, neuro, renal, and general imaging	—	—

2. Regional Market Distribution

Region	Market Share (2022)	Key Drivers	Projected Growth (2023-2028)
North America	40%	High healthcare expenditure, advanced imaging infrastructure	4.0%
Europe	30%	Aging population, clinical adoption	4.3%
Asia-Pacific	20%	Expanding healthcare access, lower contrast agent costs	6.0%
Rest of World	10%	Emerging markets	5.2%

3. Competitive Landscape

Key Players	Market Share (%)	Products	Strengths
GE Healthcare	35%	Omnipaque (Iohexol), others	Extensive R&D, global reach
Bayer	25%	Ultravist (iopromide), others	Broad portfolio, clinical legacy
Guerbet	15%	Lipiodol, other contrast media	Innovative formulations
Others	25%	Various regional and generic brands	Cost competitiveness

4. Pricing and Reimbursement

Average Cost per Dose	USD	Reimbursement Policies	Impact on Market
$25 - $50	Depending on region and volume	Varies; often covered by insurance in developed countries	Higher reimbursement supports adoption in complex procedures

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Market Projection for Iodixanol (2023-2028)

Scenario	CAGR	Key Assumptions	Notes
Baseline	4.2%	Continuation of current trends, regulatory stability	Market reaches approximately USD 4.5 billion by 2028
Optimistic	6.0%	Faster adoption in Asia-Pacific, expanded indications	Upward trend driven by emerging markets and technological advances
Conservative	3.5%	Regulatory delays, competitive challenges	May result in USD 4.0 billion by 2028

Key Drivers of Growth

• Technical innovation: Improved imaging protocols increasing contrast agent efficiency
• Regulatory approvals: Expansion into pediatric and neuroimaging segments
• Aging global population: Rising demand for diagnostic imaging for cardiovascular and neurodegenerative conditions
• Health expenditure expansion: Particularly in Asia-Pacific and Latin America

Potential Challenges

• Competitive pressure from lower-cost ionic agents
• Stringent regulatory standards, especially for pediatric and renal safety
• Market saturation in mature regions
• Alternative imaging modalities reducing contrast media dependency

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Comparison with Other Contrast Agents

Parameter	Iodixanol	Iohexol (Omnipaque)	Iopamidol (Isovue)	Other Agents
Osmolarity	ISO-osmolar	Theoretical hypo-osmolar	Hypo-osmolar	Varies
Toxicity Profile	Low nephrotoxicity	Higher risk in CKD	Similar	Varies
Imaging Quality	Superior in certain cases	Good	Good	Variable
Indications	Angiography, CT	Angiography, CT	CT, some angiography	Specialized uses

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Deep Dive into Key Factors Impacting the Market

• Technological advancements: Integration with high-resolution MRI, 3D imaging, and AI-enhanced diagnostics.
• Regulatory environment: Accelerated approvals for pediatric use and in emerging markets.
• Healthcare spending shifts: Increased investment in imaging infrastructure in developing countries.
• Competitive innovation: Development of lower-cost, high-safety alternatives could impact market share.

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FAQs

1. What is the primary clinical advantage of iodixanol over other contrast agents?
Iodixanol's ISO-osmolarity reduces the risk of nephrotoxicity, especially in vulnerable patient populations, and has demonstrated superior imaging quality in specific applications.

2. Are there ongoing trials investigating new indications for iodixanol?
Yes; current studies are exploring its use in neuroimaging, cardiac MRI, and in COVID-19 patients with renal complications, aiming to expand its clinical utility.

3. How is the market share of iodixanol expected to evolve globally?
While mature markets may see stabilization, significant growth is projected in Asia-Pacific due to healthcare expansion, aging populations, and adoption of advanced imaging.

4. What regulatory hurdles could impact iodixanol’s future market?
Potential hurdles include approvals for pediatric uses, off-label indications, and stringent safety evaluations, especially concerning renal toxicity.

5. How does the competitive landscape influence manufacturer strategies?
Market players focus on innovation, cost reduction, expanding indications, and regulatory compliance to maintain or enhance market share.

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Key Takeaways

• Clinical trials consistently affirm iodixanol’s safety profile, with ongoing research extending its potential applications.
• The market remains robust, supported by technological advances, demographic trends, and expanding healthcare infrastructure.
• Market growth is projected at around 4-6% CAGR through 2028, driven predominantly by Asia-Pacific and emerging markets.
• Competitive positioning depends on continuous innovation, safety improvements, and regulatory navigation.
• Healthcare providers and investors should monitor regulatory updates, clinical trial outcomes, and regional adoption trends for strategic decisions.

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References

[1] MarketWatch, "Contrast Media Market Size & Forecast 2022-2028," July 2022.
[2] ClinicalTrials.gov, "Iodixanol Clinical Trials," accessed October 2023.
[3] FDA, "Iodixanol (Visipaque) Regulatory History," 2002.
[4] European Medicines Agency, "Summary of Product Characteristics: Visipaque," 2003.
[5] IQVIA, "Global Contrast Agents Market Analysis," 2022.