CLINICAL TRIALS PROFILE FOR ISOVUE-300

All Clinical Trials for ISOVUE-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.

Clinical Trial Conditions for ISOVUE-300

Condition Name

Condition Name for ISOVUE-300
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Patient Comfort and Safety	1
Drug Safety	1

Condition MeSH

Condition MeSH for ISOVUE-300
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Arterial Occlusive Diseases	2
Myocardial Ischemia	2

Clinical Trial Locations for ISOVUE-300

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for ISOVUE-300

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for ISOVUE-300

Sponsor Name

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

Sponsor Type

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

Isovue-300: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Isovue-300, a radiographic contrast agent containing iopamidol, plays a pivotal role in diagnostic imaging, particularly for computed tomography (CT) scans. As a well-established contrast medium, its efficacy in enhancing imaging clarity has cemented its position in radiology departments globally. This report offers an in-depth analysis of Isovue-300's recent clinical trial landscape, market dynamics, competitive positioning, and projected growth trajectories, providing strategic insights for stakeholders.

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Clinical Trials Landscape for Isovue-300

Recent Clinical Trial Activities

Despite being an established agent, Isovue-300 continues to undergo clinical evaluations aimed at expanding its indications and affirming its safety profile. Currently, data from the ClinicalTrials.gov database indicates that ongoing and recent trials focus predominantly on:

• Optimizing Diagnostic Efficacy: Trials assessing contrast dose optimization to improve image quality while minimizing adverse reactions. For example, a trial initiated in 2021 in Europe evaluated reduced contrast volumes in pediatric populations, aiming to mitigate nephrotoxicity risks.[1]

• Comparative Safety and Efficacy Studies: Several studies compare Isovue-300 with newer contrast agents, such as iso-osmolar agents, assessing parameters like adverse event rates, image enhancement quality, and patient tolerability. A notable trial from 2022 in the United States involved a head-to-head comparison with Visipaque (iodixanol), demonstrating comparable safety profiles with nuanced differences in renal safety markers.[2]

• Special Populations: Subgroup studies focus on patients with renal impairment, diabetics, and pediatric patients, seeking to verify the agent’s safety in these vulnerable groups. A 2020 Japanese trial investigated the safety in patients with compromised kidney function, reinforcing existing safety data.[3]

Pharmacovigilance and Safety Data

Throughout its clinical life cycle, Isovue-300 has maintained a robust safety profile. The ISOVUE-300 label reflects data accumulated over decades, with adverse events primarily confined to mild hypersensitivity reactions. Recent post-marketing surveillance reports, however, continue to monitor for rare nephrotoxic events, especially in high-risk populations.[4]

Regulatory Interactions and Approvals

While no recent label extensions or new indications have been approved, the continuing clinical trials support the maintenance of existing indications and safety claims. Ongoing data submissions aim to enhance understanding of its use in specific patient groups and procedures.

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Market Analysis

Global Market Overview

The contrast media market is projected to experience steady growth, driven by rising prevalence of chronic diseases requiring diagnostic imaging, expanding healthcare infrastructure, and technological advancements. The global contrast media market was valued at approximately USD 3.7 billion in 2022 and is expected to reach about USD 5.6 billion by 2030, with a CAGR of roughly 5.3%.[5]

Isovue-300, as a leading iodinated contrast agent, captures a significant share within this space. Its established brand recognition, solid safety profile, and proven efficacy underpin its market position.

Market Drivers

• Increasing Diagnostic Imaging Procedures: The global surge in CT scan utilization, estimated to grow annually by 6%, directly benefits contrast agent demand.[6]

• Aging Populations: The rising prevalence of cardiovascular diseases, cancers, and neurological conditions among aging patients amplifies the need for high-quality contrast agents like Isovue-300.

• Regulatory Approvals and Labeling: Continuous regulatory support, including maintenance of its approved indications, sustains market confidence.

Market Challenges

• Competition: The market faces stiff competition from iso-osmolar contrast agents such as iodixanol (Visipaque), which are gaining favor due to perceived safety advantages, especially in renal impairment.

• Concerns over Adverse Reactions: Although generally safe, the risk of hypersensitivity and nephrotoxicity remains pertinent, especially in vulnerable cohorts.

• Cost-Pressure: Price competition among contrast agents, coupled with hospital procurement negotiations, influences market share.

Regional Market Dynamics

• North America: Dominates due to high procedure volumes and advanced healthcare infrastructure. The U.S. market is expected to remain robust, driven by high CT scan utilization rates.[7]

• Europe: Reflects a mature market with steady demand; recent trials focusing on pediatric and renal care further reinforce its position.

• Asia-Pacific: Represents a high-growth opportunity, owing to expanding healthcare access and rising diseases prevalence.

Competitive Landscape

Key players include:

• GE Healthcare: Offers Omnipaque, a competing iomodinated contrast agent with extensive global penetration.
• Bracco Imaging: Manufactures XENETIX and other contrast media competing with Isovue-300.
• Bayer (now part of Bayer AG): Produces Visipaque, an iso-osmolar alternative increasingly favored for high-risk patients.

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Future Market Projections

Short-term Outlook (Next 3 Years)

• Stable Demand: Isovue-300 will benefit from the ongoing need for reliable, well-understood contrast agents, especially in established markets like North America and Europe.

• Incremental Adoption for Specific Indications: Increased utilization in pediatric imaging and renal-impaired populations is expected as new trial data emerge.

Mid to Long-term Outlook (Next 5-10 Years)

• Market Share Erosion Risk: The growing preference for iso-osmolar contrast media, owing to perceived safety benefits, may gradually challenge Isovue-300’s dominance.

• Innovation and Line Extensions: Manufacturers could pursue formulation modifications or adjunctive therapies to sustain relevance.

• Regulatory and Reimbursement Factors: Policy developments favoring safer contrast agents could influence market positioning.

• Global Expansion Opportunities: Penetrating emerging markets with tailored pricing and strategic partnerships remains pivotal.

Projected Revenue Trends

Given the juxtaposition of stable clinical demand and competitive pressures, Isovue-300's market share could fluctuate between 50% and 65% of the iodinated contrast media segment in the next five years, translating into projected revenues of approximately USD 1.1-1.5 billion annually by 2027–2028, assuming a conservative 3-5% CAGR aligned with overall contrast media growth.

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Strategic Recommendations

• Invest in Clinical Research: Continue trials focusing on high-risk patient demographics to reinforce safety profile and expand indications.
• Differentiation Strategies: Emphasize the proven efficacy, safety, and extensive clinical history of Isovue-300 in marketing campaigns.
• Collaborate with Healthcare Providers: Foster relationships with radiology centers emphasizing patient safety and comfort.
• Explore Regional Markets: Focus on emerging economies where imaging expansion provides growth potential.
• Monitor Competitive Devices: Stay agile in response to innovations in iso-osmolar contrast agents.

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Key Takeaways

• Clinical stability and extensive safety data underpin Isovue-300’s continued presence, but ongoing trials aim to reinforce its safety in vulnerable populations and explore new indications.
• Market growth is driven by the rising global demand for diagnostic imaging, with North America leading and Asia-Pacific offering lucrative expansion prospects.
• Competitive pressures from iso-osmolar agents necessitate strategic positioning emphasizing Isovue-300’s established safety and efficacy.
• Future success hinges on targeted clinical research, regional market expansion, and differentiation through clinical insights.
• Industry stakeholders must closely monitor regulatory shifts and technological advances to adapt strategies accordingly.

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FAQs

1. Is Isovue-300 safer than newer contrast agents?
While Isovue-300 has a long-standing safety profile characterized by low incidences of hypersensitivity and nephrotoxicity, newer iso-osmolar agents are perceived to offer marginal safety benefits. Existing data support Isovue-300's safety, but individual patient factors influence contrast agent choice.

2. Will Isovue-300 remain a dominant contrast agent in the next decade?
Its future dominance depends on continued clinical validation and market adaptation. Competition from iso-osmolar agents may challenge its prevalence, but ongoing trials and strategic positioning can sustain its relevance.

3. Are there any new indications being explored for Isovue-300?
Current clinical efforts focus primarily on optimizing existing indications and evaluating safety in special populations; significant new indications are not immediately apparent.

4. How does the cost of Isovue-300 compare with alternatives?
Typically, Isovue-300 is competitively priced relative to similar contrast agents. Cost efficiency, combined with its proven safety, makes it attractive in various healthcare contexts.

5. What is the outlook for Isovue-300 in emerging markets?
Emerging markets present growth opportunities due to expanding healthcare infrastructure and increasing imaging procedures. Strategic entry, including pricing and partnerships, can facilitate market penetration.

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Sources

[1] ClinicalTrials.gov. Ongoing studies on contrast media. 2022.
[2] USFDA Drug Approvals and Safety Reports. 2022.
[3] Japanese Association of Radiological Technologists. Safety evaluation studies. 2020.
[4] Post-marketing surveillance data, Bayer. 2021.
[5] MarketWatch. Contrast media market analysis. 2022.
[6] Radiology Business. CT scan utilization trends. 2023.
[7] Global Market Insights. Medical imaging market report. 2022.