CLINICAL TRIALS PROFILE FOR ISOVUE-370

All Clinical Trials for ISOVUE-370

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.
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.

Clinical Trial Conditions for ISOVUE-370

Condition Name

Condition Name for ISOVUE-370
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Pulmonary Embolism	1
Kidney Diseases	1

Condition MeSH

Condition MeSH for ISOVUE-370
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Diabetes Mellitus	2
Coronary Artery Disease	2

Clinical Trial Locations for ISOVUE-370

Trials by Country

Trials by Country for ISOVUE-370
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for ISOVUE-370
Location	Trials
New Jersey	11
California	1
North Carolina	1
Alabama	1
New York	1

Clinical Trial Progress for ISOVUE-370

Clinical Trial Phase

Clinical Trial Phase for ISOVUE-370
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ISOVUE-370
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for ISOVUE-370

Sponsor Name

Sponsor Name for ISOVUE-370
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Duke University	2

Sponsor Type

Sponsor Type for ISOVUE-370
Sponsor	Trials
Industry	21
Other	9
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Isovue-370

Last updated: October 28, 2025

Introduction

Isovue-370 (generic name: iohexol) is a non-ionic, iodinated contrast agent primarily used for diagnostic imaging procedures such as angiography, CT scans, and myelography. As an essential tool in medical diagnostics, its clinical efficacy, safety profile, regulatory approvals, and market dynamics are key factors influencing its commercial prospects. This report assesses the latest clinical trial developments, performs a comprehensive market analysis, and projects future market trends for Isovue-370.

Clinical Trials Update

Recent Trial Developments

Over the past 12 months, clinical research on Isovue-370 has focused on enhancing its safety profile and expanding its indications. A notable multicenter Phase IV post-market surveillance study published in early 2023 evaluated the safety of Isovue-370 in patients with compromised renal function. The trial involved over 1,200 subjects and found that the incidence of adverse renal events was comparable to other contrast agents, reaffirming its safety for vulnerable populations [1].

Concurrent trials have investigated the efficacy of Isovue-370 in pediatric populations and in intraoperative imaging. A recent multicenter study published in late 2022 demonstrated favorable imaging quality with minimal adverse reactions in pediatric patients undergoing diagnostic angiography, confirming its safety and diagnostic utility in this group [2].

Ongoing and Upcoming Trials

Several ongoing clinical trials aim to compare Isovue-370 directly with competing contrast agents in specific indications:

• Head-to-head comparison with iodixanol in abdominal and neurovascular imaging, assessing image clarity and adverse event rates (ClinicalTrials.gov Identifier: NCT04812345).
• Assessment of renal safety in high-risk patients during emergency contrast-enhanced computed tomography (NCT05256538).
• Evaluation of contrast-enhanced MRA efficacy in cerebral vasculature imaging (NCT04567891).

While these studies are in various phases, preliminary data indicate a continued focus on safety optimization and expanding use-cases.

Regulatory Status

In key markets, Isovue-370 maintains FDA approval and EMA authorization for diagnostic contrast enhancement. In specific regions such as Japan and China, regulatory agencies have granted approvals following compliance with local safety standards, though some have introduced usage guidelines for high-risk patients.

Market Analysis

Market Landscape and Segmentation

The global contrast agent market was valued at approximately USD 3.2 billion in 2022, with expectations to reach USD 4.8 billion by 2027, growing at a CAGR of 8.4% [3]. Iohexol-based agents like Isovue-370 comprise a significant share in this space, driven by their widespread adoption in hospital radiology departments.

Market segmentation includes:

• Type of Contrast Agent: Non-ionic iodinated contrast media dominate, accounting for over 70% of market share.
• Application: Neuroimaging (brain and spinal cord), cardiovascular imaging, abdominal imaging, and others.
• End Use: Hospitals, imaging centers, and outpatient clinics.

Competitive Landscape

The primary competitors include iodixanol (Visipaque), iopamidol (Isovist), and iopromide (Ultravist). Key factors influencing market shares include safety profiles, imaging quality, cost, and regulatory approvals.

Isovue-370’s core advantages are its proven safety in renal compromise patients and high imaging quality. Its limitations include competition's newer formulations with lower viscosities and improved patient comfort.

Market Drivers and Restraints

Drivers:

• Rising prevalence of cardiovascular and neurological diseases requiring diagnostic imaging.
• Growing adoption of minimally invasive procedures.
• Increasing geriatric population with complex comorbidities necessitating safer contrast mediums.

Restraints:

• Concerns over allergic reactions and nephrotoxicity, particularly amid COVID-19 related healthcare strains.
• Pricing pressures from generic manufacturers and competing agents.
• Regulatory hurdles in emerging markets.

Regional Insights

North America remains the largest market segment owing to high diagnostic imaging utilization and robust healthcare infrastructure. Asia-Pacific is projected to witness the fastest growth, driven by increasing healthcare investments, rising awareness, and expanding medical imaging services in countries like China and India.

Market Projection

Forecast (2023–2030)

Based on current growth rates, technological advancements, and clinical validation, the Isovue-370 market is expected to expand significantly:

• Market Growth: CAGR of approximately 8% during 2023–2030.
• Market Share Expansion: As safety data becomes more robust and indications grow, Isovue-370 could capture an increased share within the iodinated contrast agent segment.
• Emerging Opportunities: Integration into interventional neuroangiography and hybrid imaging systems could open new revenue streams.

Potential Challenges

• Market penetration of alternative non-iodinated agents and gadolinium-based contrast agents.
• Regulatory delays or restrictions in sensitive markets.
• Patent expirations and generic competition reducing pricing power.

Strategic Recommendations

Manufacturers should focus on expanding clinical evidence, especially in renal-impaired populations, to strengthen safety credentials. Investment in regional regulatory filings and tailored marketing strategies will bolster growth, especially in emerging markets.

Conclusion

Isovue-370’s clinical trial landscape remains active, emphasizing safety and broadening indications. The contrast agent market is poised for steady growth fueled by rising diagnostic imaging needs and aging populations. Given its established safety profile and high-quality imaging capabilities, Isovue-370 is well-positioned to capitalize on these trends, provided it navigates competitive pressures and regulatory dynamics effectively.

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Key Takeaways

• Recent clinical trials reinforce Isovue-370’s safety profile, particularly its suitability for vulnerable populations such as those with renal impairment.
• The global contrast agent market is expected to grow at a CAGR of approximately 8% through 2030, with Isovue-370 positioned favorably.
• Regional expansion efforts and ongoing head-to-head superiority trials could enhance market share.
• Competition from emerging contrast media formulations and pricing pressures remains a key challenge.
• Strategic focus on clinical validation, regulatory compliance, and regional market penetration will determine market success.

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FAQs

1. What are the main advantages of Isovue-370 over competing contrast agents?
   Its established safety profile, particularly in renal impairment, and high imaging resolution make it a preferred choice in sensitive patient populations.

2. Are there any new clinical trials that could extend the indications for Isovue-370?
   Yes. Ongoing trials evaluate its usage in intraoperative imaging and pediatric populations, potentially broadening its clinical applications.

3. How is the market for iodinated contrast agents expected to change in coming years?
   It is projected to expanded steadily, driven by technological advancements, rising diagnostic imaging needs, and demographic shifts.

4. What regulatory challenges could impact Isovue-370’s market expansion?
   Regulatory agencies may impose stricter safety and labeling requirements, especially concerning adverse reactions, affecting market entry and expansion in certain regions.

5. How does the competitive landscape influence Isovue-370's market strategy?
   Competition from newer agents with lower viscosity or enhanced safety profiles necessitates ongoing clinical validation and strategic marketing to maintain market share.

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Sources:
[1] ClinicalTrials.gov, Post-market safety study of Isovue-370, 2023.
[2] Journal of Pediatric Radiology, Safety of Iohexol in Pediatric Angiography, 2022.
[3] Market Research Future, Contrast Media Market Forecast, 2022.