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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR IODIXANOL


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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 Visipaqueâ„¢ (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.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

Condition MeSH for Iodixanol
Intervention Trials
Renal Insufficiency 10
Coronary Artery Disease 7
Myocardial Ischemia 6
Renal Insufficiency, Chronic 6
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Clinical Trial Locations for Iodixanol

Trials by Country

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

Trials by US State for Iodixanol
Location Trials
New Jersey 9
California 4
New York 3
Illinois 3
Texas 2
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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
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Clinical Trial Status

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

Sponsor Name

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

Sponsor Type for Iodixanol
Sponsor Trials
Other 34
Industry 30
U.S. Fed 1
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Clinical Trials, Market Analysis, and Projections for Iodixanol

Introduction to Iodixanol

Iodixanol, a third-generation, nonionic, dimeric iodinated contrast agent, has been widely used in various medical imaging procedures, including cerebral angiography, cardiovascular angiography, and computed tomography (CT) scans. Developed by Nycomed (now part of GE Healthcare), iodixanol is known for its isosmotic properties, making it less harmful to patients compared to earlier contrast agents.

Clinical Trials and Efficacy

Comparative Studies with Other Contrast Agents

In a phase III clinical trial, iodixanol at a concentration of 320 mg I/ml was compared to iohexol at 300 mg I/ml in cerebral angiography. The results indicated that iodixanol is comparable to iohexol in terms of both efficacy and safety. Both contrast agents provided diagnostically adequate cerebral angiograms, and there were no statistically significant differences in the proportion or intensity of adverse events between the two groups[1].

Renal Safety

Recent clinical trials have highlighted the renal safety of iodixanol, particularly in patients with preexisting renal insufficiency and diabetes. The NEPHRIC study demonstrated a significant reduction in the incidence of contrast-induced nephropathy (CIN) when using iodixanol compared to low-osmolar agents. The peak rise in serum creatinine was significantly lower with iodixanol, and the incidence of CIN decreased from 26% to 3%[3].

Cardiovascular Applications

Iodixanol has also been evaluated for its use in coronary CT angiography (CCTA). A clinical review by the FDA supported the expansion of iodixanol's indication to include CCTA for the evaluation of patients with suspected coronary artery disease. The study showed that iodixanol-enhanced CCTA provided accurate visualization of coronary arteries and was safe for use in this context[4].

Market Analysis

Global Market Size and Growth

The global iodixanol injection market was valued at approximately $3.2 billion in 2023 and is projected to grow to around $5.1 billion by 2032. This growth is driven by increasing demand for advanced medical imaging procedures and the expanding use of CT and MRI equipment worldwide[5].

Chinese Market

In China, the sales value of iodixanol increased significantly from 2016 to 2020, reaching approximately CNY1.49 billion in 2020. The market experienced a slight slowdown due to the COVID-19 pandemic but is expected to recover and grow from 2021 to 2025. The main manufacturers in China include GE Healthcare, Jiangsu Hengrui Medicine, Yangtze River Pharmaceutical, Nanjing Chia Tai Tianqing Pharmaceutical, and Beijing Beilu Pharmaceutical[2].

Competitive Landscape

The competitive landscape of the iodixanol market in China is diverse, with several key players. GE Healthcare's VISIPAQUE remains a dominant brand, while local manufacturers such as Jiangsu Hengrui Medicine and Yangtze River Pharmaceutical also hold significant market shares. The prices of iodixanol vary by manufacturer and region, reflecting the competitive dynamics of the market[2].

Market Projections

Recovery and Growth Post-Pandemic

The COVID-19 pandemic had a temporary impact on the sales of iodixanol, particularly in China, due to reduced hospital operations. However, as the pandemic situation improves, the market is expected to recover and grow. The analyst predicts that sales of iodixanol will increase due to market expansion and the increasing demand for CT and MRI procedures[2].

Expansion of Medical Imaging Equipment

The holding volume of CT and MRI equipment in China is significantly lower than in developed countries like the U.S. and Japan. As the healthcare infrastructure in China continues to develop, the demand for contrast agents like iodixanol is expected to rise, driving market growth[2].

Key Factors Influencing Market Development

Impact of COVID-19

The COVID-19 pandemic had a short-term negative impact on the iodixanol market, but the recovery is anticipated as hospital operations return to normal. The pandemic highlighted the importance of robust healthcare infrastructure and the need for reliable diagnostic tools, which could drive long-term growth[2].

Market Drivers and Opportunities

  • Increasing Demand for Advanced Imaging: The growing need for precise diagnostic imaging in various medical specialties is a significant driver for the iodixanol market.
  • Expansion of Healthcare Infrastructure: The increasing number of CT and MRI machines in developing countries will drive the demand for contrast agents.
  • Renal Safety: The proven renal safety of iodixanol, especially in patients with preexisting renal issues, is a key advantage that could increase its adoption[3].

Market Threats and Challenges

  • Competition from Other Contrast Agents: The market for contrast agents is competitive, with various products available, each with its own advantages and disadvantages.
  • Regulatory Changes: Changes in regulatory approvals or safety guidelines could impact the market dynamics.
  • Economic Factors: Economic downturns or healthcare budget constraints could affect the demand for contrast agents[2].

Conclusion

Iodixanol has established itself as a safe and effective contrast agent in various medical imaging procedures. Clinical trials have consistently shown its efficacy and safety, particularly in reducing the risk of contrast-induced nephropathy. The market for iodixanol is expected to grow globally, driven by the increasing demand for advanced medical imaging and the expansion of healthcare infrastructure. As the pandemic situation improves, the Chinese market, in particular, is anticipated to recover and grow, making iodixanol a significant player in the contrast agent market.

Key Takeaways

  • Clinical Efficacy: Iodixanol is comparable to other contrast agents in terms of efficacy and safety.
  • Renal Safety: Iodixanol reduces the risk of contrast-induced nephropathy, especially in patients with preexisting renal insufficiency.
  • Market Growth: The global iodixanol market is projected to grow significantly by 2032.
  • Chinese Market Recovery: The Chinese market is expected to recover and grow post-pandemic.
  • Competitive Landscape: The market is competitive, with several key players, including GE Healthcare and local Chinese manufacturers.

FAQs

What is iodixanol used for?

Iodixanol is used for various medical imaging procedures, including cerebral angiography, cardiovascular angiography, CT scans of the head and body, excretory urography, and peripheral venography[4].

How does iodixanol compare to other contrast agents in terms of safety?

Iodixanol has been shown to be comparable to other contrast agents like iohexol in terms of safety and efficacy. It also has a lower incidence of contrast-induced nephropathy compared to low-osmolar agents[1][3].

What is the current market size of iodixanol globally?

The global iodixanol injection market was valued at approximately $3.2 billion in 2023[5].

Which companies are the main manufacturers of iodixanol in China?

The main manufacturers in China include GE Healthcare, Jiangsu Hengrui Medicine, Yangtze River Pharmaceutical, Nanjing Chia Tai Tianqing Pharmaceutical, and Beijing Beilu Pharmaceutical[2].

How has the COVID-19 pandemic affected the iodixanol market?

The COVID-19 pandemic temporarily reduced the sales of iodixanol due to decreased hospital operations, but the market is expected to recover and grow as the pandemic situation improves[2].

Sources

  1. Phase III clinical trial comparing iodixanol and iohexol in cerebral angiography. PubMed.
  2. Investigation Report on China's Iodixanol Market, 2016-2020 & 2021-2025. Business Wire.
  3. Recent clinical trials of iodixanol. PubMed.
  4. Clinical Review Karen Bleich NDA 020351 Supplement 44 (CCTA) Visipaque (iodixanol). FDA.
  5. Iodixanol Injection Market Research Report 2032. Dataintelo.

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