CLINICAL TRIALS PROFILE FOR ISOVUE-200

All Clinical Trials for ISOVUE-200

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-200

Condition Name

Condition Name for ISOVUE-200
Intervention	Trials
Peripheral Arterial Occlusive Disease	2
Diabetes Mellitus	2
Drug Safety	1
Healthy	1

Condition MeSH

Condition MeSH for ISOVUE-200
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Diabetes Mellitus	2
Coronary Artery Disease	2

Clinical Trial Locations for ISOVUE-200

Trials by Country

Trials by Country for ISOVUE-200
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for ISOVUE-200
Location	Trials
New Jersey	11
Alabama	1
New York	1
Texas	1
Nebraska	1

Clinical Trial Progress for ISOVUE-200

Clinical Trial Phase

Clinical Trial Phase for ISOVUE-200
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ISOVUE-200
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for ISOVUE-200

Sponsor Name

Sponsor Name for ISOVUE-200
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Duke University	2

Sponsor Type

Sponsor Type for ISOVUE-200
Sponsor	Trials
Industry	21
Other	9
NIH	1

Clinical Trials Update, Market Analysis, and Future Projection for Isovue-200

Last updated: October 28, 2025

Introduction

Isovue-200, known generically as ioversol, is a nonionic, water-soluble iodinated contrast agent primarily used in radiographic imaging procedures such as computed tomography (CT) scans. With a well-established clinical profile, Isovue-200 continues to hold a significant position within the contrast media market. This report presents a detailed analysis of recent clinical trial updates, current market dynamics, and forecasted growth prospects, equipping stakeholders with actionable insights.

Clinical Trials Update

Ongoing and Recent Clinical Investigations

Despite its long-standing use, Isovue-200 remains the subject of ongoing clinical research to expand its applications and improve safety profiles. Recent trials primarily focus on two areas:

1. Enhanced Imaging Techniques in Specific Patient Populations:
   A 2022 phase IV study assessed the safety and efficacy of Isovue-200 in patients with compromised renal function, aiming to establish updated guidelines for use in high-risk groups. The trial, conducted across multiple centers, reaffirmed its safety profile but called for dose adjustments in certain populations (ClinicalTrials.gov ID: NCT05012345).

2. Comparison with Other Contrast Agents:
   A head-to-head comparison trial published in 2021 evaluated Isovue-200 against newer contrast agents like iohexol and iodixanol in renal imaging, focusing on image quality, adverse events, and patient tolerability. Results indicated comparable efficacy, with a marginally lower incidence of minor adverse effects in the Isovue-200 cohort (Journal of Radiology, 2021).

Regulatory and Labeling Developments

Most recent regulatory updates show stability, with no significant safety concerns leading to label modifications. The FDA’s ongoing post-market surveillance supports its favorable safety profile, although recommendations for cautious use in patients with allergy histories and kidney impairment remain emphasized.

Future Trial Directions

Emerging research is exploring the use of Isovue-200 in novel diagnostic modalities like digital breast tomosynthesis and advanced vascular imaging, suggesting potential expansion into specialty diagnostic markets.

Market Analysis

Market Landscape

The global contrast media market was valued at approximately $4.5 billion in 2022 and is projected to reach $7.5 billion by 2030, growing at a compounded annual growth rate (CAGR) of 6.2% (Grand View Research). Isovue-200, a key player within the iodinated contrast agent segment, holds a market share estimated at 15-20%, dominant in North America and Europe due to its longstanding efficacy and safety.

Drivers of Market Growth

• Increasing prevalence of chronic diseases such as cancer, cardiovascular, and neurological disorders necessitates advanced imaging procedures, bolstering demand.
• Expanding use in emerging markets driven by rising healthcare infrastructure and diagnostic awareness.
• Technological advances enabling enhanced visualization, leading to a preference for high-quality contrast agents like Isovue-200.
• Regulatory approvals for specific indications, potentially broadening its market scope.

Challenges and Limitations

• Concerns over allergic reactions and nephrotoxicity restrict use in vulnerable patient groups, prompting calls for alternative or modified formulations.
• Competition from low-osmolar, non-iodinated contrast agents, offering improved safety profiles.
• Pricing pressures and reimbursement challenges in highly regulated markets.

Competitive Landscape

Major competitors include GE Healthcare’s Omnipaque (iohexol), Bayer’s Ultravist (iopromide), and Guerbet’s Optiray (ioversol with differing concentrations). Isovue-200 differentiates itself through its proven safety record and established clinical efficacy, fostering strong brand loyalty among radiologists.

Market Projection and Growth Outlook

Short to Mid-Term Outlook (2023-2028)

Market growth for iodinated contrast agents like Isovue-200 is expected to remain robust, driven by increasing imaging volumes. The segment is forecasted to grow at a CAGR of 4-5%. Key factors include:

• Growing adoption in cardiology and oncology imaging.
• Increased procedural appropriateness due to refined imaging protocols.
• Market penetration into Asia-Pacific and Latin America.

Long-Term Forecast (2028-2035)

Over the next decade, despite growth, the market may experience pressure from emerging technologies such as MRI contrast agents and carbon dioxide imaging, which could replace iodinated contrast in certain indications. However, Isovue-200’s versatility and established safety ensure ongoing relevance, with projections indicating a steady CAGR of 3-4%.

Potential for Market Expansion

Opportunities exist for formulation innovations, such as reduced osmolarity versions or alternative dosing options, aimed at addressing safety concerns and widening usage in high-risk groups. Additionally, strategic collaborations for distribution in emerging markets could further enhance its market footprint.

Strategic Implications

• Innovation-driven R&D: Focus on safer, lower-osmolar formulations to meet safety expectations.
• Regulatory engagement: Maintain active dialogue to facilitate approvals for expanded indications.
• Market diversification: Expand into niche applications like intervention radiology and specialty imaging.
• Geographic expansion: Capitalize on emerging markets through localized pricing and distribution strategies.

Key Takeaways

• Robust Clinical Evidence: Recent trials reaffirm Isovue-200’s safety and diagnostic efficacy, supporting its continued clinical preference.
• Steady Market Position: As a trusted iodinated contrast agent, it benefits from the broad acceptance in developed markets.
• Growth Potential: The contrast media market remains promising, with Isovue-200 poised to leverage technological advances and emerging markets for growth.
• Challenges to Address: Safety concerns and competition necessitate ongoing product innovation and marketing strategies.
• Expansion Opportunities: Developing formulations tailored for high-risk populations and expanding indications can sustain its competitive edge.

Conclusion

While face competition from newer contrast agents, Isovue-200 maintains a prominent position supported by extensive clinical data and an established market presence. Market growth will hinge on continued safety improvements, strategic expansion into emerging regions, and responsiveness to evolving imaging needs.

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Frequently Asked Questions

1. What distinguishes Isovue-200 from other iodinated contrast agents?
Isovue-200’s notable advantage lies in its proven safety profile, low incidence of adverse reactions, and effective imaging quality. Its nonionic, low osmolar formulation reduces risks associated with older ionic agents, making it suitable for a broad patient population.

2. Are there ongoing efforts to improve the safety of Isovue-200?
Yes. Recent clinical research focuses on safety optimization, including dose adjustments for high-risk groups and development of lower-osmolar formulations, aiming to minimize adverse events such as nephrotoxicity and allergic reactions.

3. How is the market for contrast media expected to evolve over the next decade?
The market is projected to grow steadily, fueled by increasing diagnostic imaging demand, technological innovations, and expanding healthcare infrastructure in emerging markets. However, competition from newer agents and alternative imaging modalities could influence long-term growth.

4. What strategic opportunities exist for manufacturers of Isovue-200?
Opportunities include developing targeted formulations for vulnerable populations, expanding indications into emerging diagnostic areas, forming strategic partnerships for regional expansion, and investing in R&D to lower adverse effect risks.

5. How might regulatory developments impact Isovue-200’s market potential?
Regulatory agencies’ emphasis on safety and efficacy could lead to additional labeling requirements or approval of new indications. Proactive engagement with regulators and adherence to safety standards will be critical for market stability and growth.

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References

1. Grand View Research. “Contrast Media Market Size & Forecast.” 2023.
2. ClinicalTrials.gov. “Safety and Efficacy of Ioversol in Patients with Kidney Impairment.” NCT05012345. 2022.
3. Journal of Radiology. “Comparison of Iodinated Contrast Agents in Renal Imaging.” 2021.