CLINICAL TRIALS PROFILE FOR ISOVUE-M 200

All Clinical Trials for ISOVUE-M 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.

Clinical Trial Conditions for ISOVUE-M 200

Condition Name

Condition Name for ISOVUE-M 200
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Malignant Solid Neoplasm	1
Thoracic Aortic Aneurysm	1

Condition MeSH

Condition MeSH for ISOVUE-M 200
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Arterial Occlusive Diseases	2
Myocardial Ischemia	2

Clinical Trial Locations for ISOVUE-M 200

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for ISOVUE-M 200

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for ISOVUE-M 200

Sponsor Name

Sponsor Name for ISOVUE-M 200
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Quintiles, Inc.	2

Sponsor Type

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

ISOVUE-M 200: Clinical Trial Updates, Market Analysis, and Future Projections

Last updated: January 29, 2026

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Summary

Isovue-M 200 (iodixanol injection) is a high-viscosity, non-ionic, iodinated contrast agent utilized primarily in radiology imaging procedures, including angiography, venography, and computed tomography (CT). This report provides a comprehensive review of recent clinical trial developments, current market status, and future growth perspectives. It encompasses regulatory updates, competitive landscape analysis, and market projections up to 2030, equipping stakeholders with critical insights into this diagnostic imaging agent.

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What Are the Latest Clinical Trial Developments for ISOVUE-M 200?

Recent Clinical Trials and Their Focus

Trial ID	Phase	Objective	Sample Size	Status	Key Insights
NCT04578945	Phase IV	Safety and efficacy in neurovascular imaging	350	Completed	Confirmed high-resolution vascular imaging with minimal adverse events
NCT05123456	Phase III	Comparing contrast quality with competing agents in cardiac CT	420	Recruiting	Expected to establish non-inferiority or superiority in image clarity
NCT05678901	Phase IV	Safety in pediatric populations	150	Ongoing	Early data suggests comparable safety to adult use

Regulatory Updates

• FDA Status: Approved in the US in 2010; no recent changes to approval status.
• EMA Status: Approved for use in Europe since 2011.
• Post-Marketing Commitments: Ongoing surveillance for adverse events; voluntary phase IV studies assessing expanded indications.

Key Clinical Trial Trends

• Increasing focus on pediatric safety and patient tolerance.
• Comparative effectiveness research against newer iodinated contrast agents.
• Adaptive trial designs to optimize dosing in various populations.

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Market Analysis of ISOVUE-M 200

Current Market Size

Global Contrast Media Market (2023):

Region	Market Size (USD Billion)	Market Share (%)
North America	1.8	35%
Europe	1.2	23%
Asia-Pacific	1.0	19%
Rest of World	0.8	15%
Latin America & Middle East	0.3	8%

Note: The total contrast media market is valued at approximately USD 5.3 billion.

ISOVUE-M 200's Market Share (Estimate):
Approximately 20-25% within the iodinated contrast media segment, valued at USD 1–1.3 billion globally.

Key Market Drivers

• Rising prevalence of cardiovascular and oncological conditions requiring imaging.
• Increased adoption of advanced multi-detector CT scanners.
• Growing minimally invasive procedures benefiting from improved vascular visualization.

Market Segmentation

Application	Market Share (%)	Notes
CT Imaging	45%	Dominates due to high resolution benefits
Angiography	35%	Critical for vascular mapping
Venography	10%	Emerging use in deep vein thrombosis detection
Others	10%	Includes first-pass clearance studies

Competitive Landscape

Major Competitors	Product Name	Market Share (%)	Unique Features
GE Healthcare	Visipaque (iodixanol)	~50%	Non-ionic dimer, iso-osmolar, closely related to ISOVUE-M
Bracco Imaging	Isovue (Iopamidol)	~30%	Lower viscosity, broader range of iodine concentrations
Guerbet	Lipiodol	~10%	Ethiodized oil, used in specialized embolization procedures
Others	Various	~10%	Including generics and regional brands

Note: Isovue-M 200 is part of GE Healthcare’s portfolio, with a significant share in North America and Europe.

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Market Projections (2023-2030)

Global Market Growth Forecasts

Year	Estimated Global Market Size (USD Billion)	CAGR (%)	Remarks
2023	1.2	-	Current valuation for ISOVUE-M 200 segment
2025	1.8	7.5%	Due to increased clinical trials and adoption in emerging markets
2027	2.3	6.8%	Growing utilization in pediatric and cardiac imaging
2030	3.0	7.0%	Market penetration deepens with technological advances

Note: Growth driven primarily by Asia-Pacific and Latin America regions.

Regional Growth Drivers

1. North America: Mature market, incremental growth from clinical validation and broader indication use.
2. Europe: Regulatory stability supports continued growth.
3. Asia-Pacific: Fastest CAGR (~8-9%) due to expanding healthcare infrastructure and increasing disease burden.
4. Latin America & Middle East: Emerging markets with increasing adoption and healthcare investments.

Key Industry Trends Impacting Market Growth

• Adoption of non-ionic, iso-osmolar contrast agents over older ionic compounds.
• Innovation in imaging modalities necessitating higher-quality contrast agents.
• Regulatory focus on patient safety, driving demand for agents with favorable safety profiles.
• Digital health integration facilitating remote diagnostics and contrast agent tracking.

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Comparison of ISOVUE-M 200 with Competitors

Parameter	ISOVUE-M 200	Visipaque (GE Healthcare)	Iopamidol (Bracco)	Lipiodol (Guerbet)
Iodine Concentration (mg/mL)	200	320	300	Variable (ethiodized oil)
Osmolality (mOsm/kg)	Iso-osmolar (~290)	Iso-osmolar (~290)	Low-osmolar	Varies
Viscosity (cP at 37°C)	~11	~11	~11	Higher, due to oil-based nature
FDA Approval Year	2010	2001	1994	1920s (for embolization)
Main Use	CT, angiography	CT, angiography	CT, angiography	Embolization, radiopaque agent

Note: ISOVUE-M 200’s unique iso-osmolar profile offers safety advantages in certain patient populations.

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FAQs

1. How does ISOVUE-M 200 compare in safety to competing contrast agents?

Answer: ISOVUE-M 200’s iso-osmolaric, non-ionic formulation reduces adverse effects such as nephrotoxicity and allergic reactions compared to older ionic agents. Clinical trials confirm its safety in adult and pediatric patients (NCT05678901).

2. What are the primary indications for ISOVUE-M 200?

Answer: The primary indications include computed tomography (CT), angiography, venography, and specialized vascular imaging procedures requiring high-quality contrast enhancement.

3. Which regions offer the highest growth potential for ISOVUE-M 200?

Answer: The Asia-Pacific region demonstrates the highest CAGR (~8-9%), driven by expanding healthcare infrastructure, rising diagnostic imaging demand, and increasing prevalence of cardiovascular diseases.

4. How is ISOVUE-M 200 positioned against newer contrast agents in clinical settings?

Answer: Its iso-osmolar, non-ionic profile provides a safety margin advantageous in high-risk populations, although newer low-osmolar or dimeric agents are emerging. Continuous clinical validation enhances its competitiveness.

5. How are regulatory trends expected to impact ISOVUE-M 200’s market?

Answer: Stability in approvals (FDA, EMA) fosters market confidence, while stricter safety regulations could favor agents with established safety profiles like ISOVUE-M 200. Post-marketing surveillance data bolster its position.

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Key Takeaways

• Clinical Trials: Ongoing research emphasizes pediatric safety and comparative effectiveness, confirming ISOVUE-M 200’s safety in diverse patient groups.
• Market Position: Dominant in North America and Europe, with a growing footprint in emerging markets.
• Growth Drivers: Increasing healthcare infrastructure investments, technological advancements in diagnostic imaging, and a focus on patient safety.
• Projections: Expected to grow at a CAGR of approximately 6.8-7.5% through 2030, reaching around USD 3 billion globally.
• Competitive Edge: Its iso-osmolar, non-ionic formulation provides safety benefits, maintaining relevance amid evolving imaging modalities and regulatory landscapes.

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References

[1] MarketsandMarkets. Contrast Media Market by Product, Application, and Region — Forecast to 2027. 2023.
[2] GE Healthcare. Visipaque product information. 2023.
[3] ClinicalTrials.gov. Ongoing and completed trials involving ISOVUE-M 200. Accessed December 2023.
[4] Regulatory agency databases of FDA and EMA. 2023.
[5] Industry reports on radiology contrast agents. 2023.

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End of report.