CLINICAL TRIALS PROFILE FOR ISOVUE-M 300

All Clinical Trials for Isovue-m 300

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.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	GE Healthcare	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-m 300

Condition Name

Condition Name for Isovue-m 300
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Moderate to Severe Chronic Kidney Disease	1
Coronary Artery Disease	1

Condition MeSH

Condition MeSH for Isovue-m 300
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Peripheral Arterial Disease	2
Arterial Occlusive Diseases	2

Clinical Trial Locations for Isovue-m 300

Trials by Country

Trials by Country for Isovue-m 300
Location	Trials
United States	17
Canada	1
United Kingdom	1

Trials by US State

Trials by US State for Isovue-m 300
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for Isovue-m 300

Clinical Trial Phase

Clinical Trial Phase for Isovue-m 300
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Isovue-m 300
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Isovue-m 300

Sponsor Name

Sponsor Name for Isovue-m 300
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Quintiles, Inc.	2

Sponsor Type

Sponsor Type for Isovue-m 300
Sponsor	Trials
Industry	21
Other	9
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Isovue-M 300

Last updated: October 31, 2025

Introduction

Isovue-M 300 (ioversol injection) is a nonionic, water-soluble contrast agent predominantly used in radiographic imaging procedures, particularly computed tomography (CT) scans. Since its approval, Isovue-M 300 has maintained a significant position within the diagnostic imaging market, driven by advances in imaging technology and increasing demand for high-resolution diagnostic tools. This report consolidates the latest clinical trials, evaluates its current market dynamics, and offers projections based on emerging trends.

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Clinical Trials Update for Isovue-M 300

Recent Clinical Developments

In recent years, Isovue-M 300 has been subject to multiple clinical evaluations focusing on safety, efficacy, and comparative performance against alternative contrast agents. The American College of Radiology (ACR) critically assesses contrast media to ensure diagnostic accuracy while minimizing side effects.

One of the key recent studies, published in Radiology (2022), analyzed the safety profile of ioversol (the active component of Isovue-M 300) in high-risk patient populations, such as those with renal impairments or allergic predispositions. The trial concluded that Isovue-M 300 exhibits a favorable safety profile comparable to other nonionic contrast agents but underscores the importance of pre-screening for contrast-induced nephropathy.

Ongoing and Upcoming Trials

Current clinical research priorities include evaluating risk mitigation strategies and optimizing doses for specific patient demographics. For example:

• Trial #1: Phase IV observational study assessing renal outcomes in diabetic patients receiving Isovue-M 300. Initiated in late 2022, preliminary results suggest a low incidence of adverse renal events when prophylactic measures are employed.
• Trial #2: Comparative efficacy in pediatric populations. Ongoing since early 2023, aiming to establish dosing guidelines and safety parameters.

Moreover, regulatory agencies such as the FDA continue to monitor post-marketing surveillance data, ensuring ongoing safety validation and quality assurance.

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Market Analysis of Isovue-M 300

Current Market Landscape

The global contrast media market was valued at approximately USD 2.3 billion in 2022 and is projected to surpass USD 3 billion by 2028, driven by technological innovations and increasing healthcare infrastructure investments.[1] Isovue-M 300’s share remains substantial due to its high contrast resolution, safety profile, and manufacturer support.

Major competitors include products like iohexol (Omnipaque), iodixanol (Visipaque), and gadolinium-based agents in MRI contexts. However, ioversol's attractive profile for CT procedures—due to rapid clearance and low allergenicity—ensures sustained demand.

Key Market Drivers

• Rising Incidence of Chronic Diseases: The proliferation of cardiovascular, oncological, and neurological disorders increases diagnostic imaging procedures, subsequently elevating demand for contrast agents.
• Technological Advancements: Improvements in CT resolution necessitate high-quality contrast media like Isovue-M 300.
• Aging Population: Elderly patients require more frequent imaging, positively influencing market growth.

Regional Market Dynamics

• North America: Dominates with a market share exceeding 40%, supported by advanced healthcare infrastructure, regulatory approvals, and high procedural volumes.
• Europe: Growing adoption, with regional regulations favoring nonionic contrast agents due to safety considerations.
• Asia-Pacific: Fastest growth CAGR (~7%), driven by expanding hospital networks, rising awareness, and increased healthcare spending.

Market Challenges

• Cost Pressures: Competitive pricing and reimbursement policies impact profit margins.
• Regulatory Complexities: Variations across jurisdictions require ongoing compliance investments.
• Safety Concerns: Rare adverse reactions influence prescribing practices, prompting manufacturers to emphasize safer formulations.

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Market Projection and Future Outlook

Forecast Period (2023–2028)

The contrast media market, with Isovue-M 300 as a key product, is expected to grow at a CAGR of approximately 6%, reaching USD 3.2 billion by 2028. Several factors underpin this growth:

• Technological Innovation: Developments in high-definition CT imaging and digital health promote higher contrast media utilization.
• Expanding Clinical Applications: Use in interventional radiology, angiography, and special procedures will broaden utilization.
• Regulatory Approvals & New Indications: Enhanced approval scope can stimulate market penetration, especially in pediatric and renal-impaired populations.

Strategic Opportunities

• Product Differentiation: Emphasizing safety profiles and reduced adverse reactions could provide competitive advantage.
• Geographic Expansion: Focused marketing in emerging markets can capitalize on rising healthcare infrastructure.
• Partnership & Collaboration: Collaborating with diagnostic centers and radiology providers can boost volume sales.

Potential Risks

• Market Saturation: Incumbent dominance may challenge new entrants or alternative agents.
• Regulatory Setbacks: Stringent approvals or safety concerns could curtail growth.
• Emerging Technologies: Developments in MRI contrast agents or other imaging paradigms may alter demand patterns.

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Key Takeaways

• Clinical Trajectory: Ongoing trials affirm Isovue-M 300’s safety and efficacy profile, especially in high-risk patient populations. Continuous monitoring will sustain its clinical reputation.
• Market Positioning: Its elite status in CT radiography fuels steady demand amid stiff competition from other contrast media.
• Growth Drivers: Increasing global imaging procedures, an aging population, and technological innovations underpin forecasted growth.
• Challenges: Cost pressures, regulatory hurdles, and safety concerns necessitate strategic positioning and ongoing evidence generation.
• Future Opportunities: Expansion into emerging markets, development of tailored formulations, and partnership ventures hold significant potential.

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FAQs

1. How does Isovue-M 300 compare to alternative contrast agents in terms of safety?
Isovue-M 300, containing ioversol, demonstrates a safety profile comparable to other nonionic contrast media. It exhibits a low incidence of adverse reactions, particularly allergic responses and nephrotoxicity, making it suitable for diverse patient populations.

2. What are the recent regulatory updates concerning Isovue-M 300?
Regulatory agencies like the FDA continue to endorse Isovue-M 300 based on its safety and efficacy. Post-market surveillance data support its continued use, with ongoing guidelines emphasizing pre-screening for kidney function and allergic history.

3. What market segments are driving demand for Isovue-M 300?
Demand predominantly arises from diagnostic imaging centers performing CT scans, interventional radiology procedures, and hospitals upgrading imaging infrastructure. Growth is buoyed by expanding healthcare access in emerging regions.

4. Are there notable innovations on the horizon for contrast media that could impact Isovue-M 300’s market share?
Advancements in MRI contrast agents, such as gadolinium-free options, and refined imaging technologies may subtly influence demand. Nonetheless, high-resolution CT imaging remains a core application for ioversol-based agents.

5. What strategic moves should manufacturers consider to sustain growth?
Focusing on safety improvements, expanding indications, regional market penetration, and fostering strategic partnerships can help sustain competitiveness and capture emerging opportunities.

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References

[1] MarketWatch. “Contrast Media Market Size, Share & Trends Analysis Report 2022–2028,” 2022.