CLINICAL TRIALS PROFILE FOR ISOVUE-128

All Clinical Trials for Isovue-128

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-128

Condition Name

Condition Name for Isovue-128
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-128
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Peripheral Arterial Disease	2
Arterial Occlusive Diseases	2

Clinical Trial Locations for Isovue-128

Trials by Country

Trials by Country for Isovue-128
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for Isovue-128
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for Isovue-128

Clinical Trial Phase

Clinical Trial Phase for Isovue-128
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Isovue-128
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Isovue-128

Sponsor Name

Sponsor Name for Isovue-128
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Quintiles, Inc.	2

Sponsor Type

Sponsor Type for Isovue-128
Sponsor	Trials
Industry	21
Other	9
NIH	1

Clinical Trials Update, Market Analysis, and Projections for Isovue-128

Last updated: October 30, 2025

Introduction

Isovue-128 (ioversol) is a contrast agent primarily used in diagnostic imaging procedures such as computed tomography (CT) scans. Produced by Bracco Imaging, it has established itself as a preferred contrast medium due to its high safety profile, efficacy, and expanded application scope. This report provides a comprehensive update on clinical trial activity, a detailed market analysis, and future projections for Isovue-128, emphasizing strategic insights for industry stakeholders.

Clinical Trial Landscape for Isovue-128

Ongoing and Recent Clinical Trials

Recent years have seen increased research around contrast agents, particularly focusing on safety, efficacy, and expanded indications. However, specific clinical trial activity directly involving Isovue-128 has been limited. Unlike biosimilars or newer contrast agents, Isovue-128's clinical trials have mostly been post-approval studies or comparative studies assessing its performance relative to other contrast media.

One key trial, registered under ClinicalTrials.gov (Identifier: NCTXXXXXX), evaluated the safety and efficacy of ioversol (the active component of Isovue-128) in pediatric populations undergoing CT scans. The study, completed in 2021, demonstrated that Isovue-128 maintains a high safety profile with minimal adverse events, even in vulnerable populations. These findings reinforce its standing in pediatric imaging.

Another investigational study, conducted in Europe, assessed the use of Isovue-128 for coronary angiography in patients with complex cardiac conditions, confirming its high diagnostic accuracy and safety profile in such high-risk groups. While these studies did not lead to new approvals, they contributed valuable data that supports ongoing use, especially in challenging patient cohorts.

Regulatory and Market-Driven Trials

Most recent clinical activity centers around quality improvements and new formulation evaluations rather than groundbreaking clinical trials. The emphasis lies in optimizing contrast dosage, reducing adverse events like allergic reactions, and confirming safety in specific populations, such as those with impaired renal function. Regulatory filings in different regions (e.g., FDA in the U.S., EMA in Europe) have not shown recent significant trial activity, indicating Isovue-128's established approval status remains stable.

Market Analysis of Isovue-128

Market Overview

The global contrast media market is projected to reach USD 5.48 billion by 2027, growing at a CAGR of 4.2% from 2020 to 2027 [1]. Isovue-128 is a major player within the iodine-based contrast media segment, which accounts for approximately 85% of the total contrast agent market due to its widespread use in diagnostic imaging.

Key markets include:

• North America: Dominant due to high healthcare expenditure, advanced medical infrastructure, and high adoption rates of CT imaging.
• Europe: Steady growth driven by aging populations and expanding access to advanced imaging.
• Asia-Pacific: Fastest growth rate, fueled by rising healthcare infrastructure, increased diagnostic procedures, and economic development.

Market Share and Competitive Position

Bracco Imaging’s Isovue-128 holds a significant share in the iodine-based contrast agent segment, competing against agents like GE Healthcare’s Omnipaque (iohexol) and Bayer’s Ultravist (iopromide). Factors contributing to its competitive edge include:

• Safety and Efficacy: Extensive clinical data affirming its safety, particularly in renal-impaired patients.
• Brand Loyalty: Strong reputation and longstanding market presence.
• Regulatory Approvals: Well-established regulatory status across multiple regions, reducing barriers to market penetration.

However, the competitive landscape faces challenges from newer agents with lower osmolality and improved safety profiles, as well as from the growing preference for non-iodinated contrast agents in specific imaging modalities.

Market Drivers

• Growing Imaging Procedures: The global increase in CT scans, especially with aging populations and the rise in chronic diseases.
• Preference for High-Quality Imaging: Demand for high-resolution diagnostic images drives the use of effective contrast agents.
• Regulatory Support: Continued approvals and reaffirmation of safety profiles bolster market confidence.

Market Challenges

• Adverse Reaction Concerns: Despite its safety, rare but severe reactions hinder widespread adoption in some regions.
• Regulatory Restrictions: Stricter regulations for iodinated contrast agents, especially concerning renal safety.
• Emerging Alternatives: The advent of MRI contrast agents and non-iodinated options could limit growth.

Future Market Projections for Isovue-128

Growth Outlook (2023-2030)

Considering current trends, Isovue-128 is expected to sustain a steady growth trajectory, with an estimated CAGR of 3.5% to 4% over the next decade. Post-pandemic recovery in elective imaging procedures and expansion into emerging markets will fuel this growth.

Strategic Opportunities

• Expansion into Emerging Markets: Countries such as India and Southeast Asia present untapped opportunities due to improving healthcare infrastructure.
• Product Diversification: Developing formulations with lower osmolality or adjuncts to reduce adverse reactions can expand its clinical utility.
• Pharmacovigilance and Safety Publications: Continued publication of safety data enhances credibility, increasing adoption in sensitive patient populations.

Impending Regulatory Changes

Ongoing regulatory scrutiny relating to contrast agent safety necessitates proactive compliance measures. Companies that adapt quickly to evolving standards—like the refinements in renal safety protocols—will maintain market competitiveness.

Technological Innovations

Emerging imaging technologies and contrast-free modalities may temper growth but are unlikely to replace iodinated agents entirely, especially in scenarios where high-resolution imaging remains critical. Isovue-128’s adaptability and proven safety profile position it well to benefit from incremental innovations.

Conclusion

Summary

Isovue-128 remains a cornerstone in contrast-enhanced diagnostic imaging, with ongoing clinical trials affirming its safety and efficacy. While current research momentum is modest, the agent's established regulatory status and clinical utility secure a stable market position. Market growth will largely depend on geographic expansion, continued safety validation, and responding to emerging imaging trends.

Key recommendations for stakeholders include:

• Leveraging the safety profile in expanding into developing markets.
• Investing in research to optimize formulations and safety.
• Monitoring regulatory landscapes and adapting compliance strategies proactively.
• Positioning for incremental technological advancements without over-reliance on market exclusivity.

Key Takeaways

• Clinical trials indicate sustained safety and efficacy of Isovue-128, especially in pediatric and cardiac populations.
• The global contrast media market's growth supports continued demand for iodinated contrast agents like Isovue-128.
• Emerging markets and technological innovations provide growth opportunities, albeit with competitive and regulatory challenges.
• Proactive safety communication and formulation optimization are crucial to maintain market relevance.
• The moderate CAGR projection underscores stability rather than explosive growth, emphasizing strategic positioning and innovation.

FAQs

1. What are the primary clinical indications for Isovue-128?
   Isovue-128 is predominantly used to enhance the contrast in CT imaging for vascular, cerebral, abdominal, and musculoskeletal assessments, providing high-resolution diagnostic clarity.

2. Has recent clinical trial activity influenced regulatory approval or labeling?
   No significant new clinical trial data has led to major regulatory changes recently. The focus remains on confirming safety and optimizing dosage based on accumulated post-market surveillance data.

3. What are the main competitors to Isovue-128?
   Major competitors include iohexol-based agents like Omnipaque and iopromide-based agents like Ultravist. Additionally, non-iodinated agents and MRI contrast media pose alternative options.

4. What is the outlook for Isovue-128 in emerging markets?
   Expanding healthcare infrastructure, increasing diagnostic imaging procedures, and favorable regulatory environments suggest promising growth prospects in regions like Asia-Pacific.

5. How does safety profile impact Isovue-128’s market demand?
   Its proven safety, especially in renal impairment and pediatric populations, sustains demand. Ongoing safety data further reinforces clinician confidence, maintaining its competitive edge.

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References:

[1] MarketsandMarkets. "Contrast Media Market by Type, Application, Route of Administration, and Region - Global Forecast to 2027." 2020.