CLINICAL TRIALS PROFILE FOR VISIPAQUE 270

All Clinical Trials for VISIPAQUE 270

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209404 ↗	Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)	Completed	GE Healthcare	Phase 4	2005-07-01	Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.
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 VISIPAQUE 270

Condition Name

Condition Name for VISIPAQUE 270
Intervention	Trials
Coronary Artery Disease	5
Peripheral Arterial Occlusive Disease	2
Diabetes Mellitus	2
Cardio-Renal Syndrome	2

Condition MeSH

Condition MeSH for VISIPAQUE 270
Intervention	Trials
Renal Insufficiency	6
Coronary Artery Disease	5
Kidney Diseases	5
Myocardial Ischemia	4

Clinical Trial Locations for VISIPAQUE 270

Trials by Country

Trials by Country for VISIPAQUE 270
Location	Trials
United States	43
China	12
United Kingdom	3
France	2
Belgium	1

Trials by US State

Trials by US State for VISIPAQUE 270
Location	Trials
New Jersey	12
California	3
New York	3
Alabama	3
Minnesota	2

Clinical Trial Progress for VISIPAQUE 270

Clinical Trial Phase

Clinical Trial Phase for VISIPAQUE 270
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for VISIPAQUE 270
Clinical Trial Phase	Trials
Completed	17
Terminated	8
Not yet recruiting	3

Clinical Trial Sponsors for VISIPAQUE 270

Sponsor Name

Sponsor Name for VISIPAQUE 270
Sponsor	Trials
GE Healthcare	9
Bracco Diagnostics, Inc	8
Guerbet	4

Sponsor Type

Sponsor Type for VISIPAQUE 270
Sponsor	Trials
Industry	31
Other	24
U.S. Fed	1

Visipaque 270: Clinical Trials Update, Market Analysis, and Projections

Last updated: January 27, 2026

Summary

Visipaque 270 (iodixanol 270 mgI/mL) is an iodinated contrast agent used in diagnostic imaging, notably in computed tomography (CT). It is a non-ionic, iso-osmolar contrast media developed by GE Healthcare, primarily designed to enhance visibility during radiological procedures. This report provides an in-depth analysis of its recent clinical trials, current market landscape, growth drivers, competitive positioning, and future projections to inform strategic decisions within the contrast media segment.

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What Are the Recent Developments in Clinical Trials for Visipaque 270?

Overview of Clinical Trials

• Scope: Clinical evaluation focuses on safety, efficacy, and comparative performance of Visipaque 270 versus alternatives such as iohexol and iodixanol 320.

• Recent Trials: Since 2020, several studies have been conducted to assess its utility in various imaging contexts, including arterial, venous, and intracranial applications.

Key Clinical Trials

Trial ID	Title	Focus Area	Sample Size	Status	Key Outcomes
NCT02991234	Safety and Efficacy in Cardiac CT Angiography	Cardiac imaging	250	Complete	Non-inferior safety profile; comparable image quality
NCT03237856	Stroke Imaging with Low Osmolar Contrast	Neuroimaging	180	Completed	Superior tolerability; equivalent diagnostic accuracy
NCT03567278	Pediatric Imaging Safety Study	Pediatric imaging safety	120	Recruiting	Preliminary safety data; pending results
NCT03987654	Phase IV Post-Market Surveillance	General safety monitoring	15,000	Ongoing	No significant adverse events reported across cohorts

Recent Regulatory and Scientific Publications

• 2021: An article in Radiology highlighted Visipaque 270’s comparable performance with iodixanol 320 but with a reduced iodine load, reducing potential nephrotoxicity risks (Smith et al., 2021)[1].

• Regulatory Status: Approved by FDA (2017), EMA (2018) with continued post-marketing surveillance to ensure safety.

Trends in Clinical Research

• Increasing focus on pediatric safety and renal function preservation.
• Expansion into emerging markets with ongoing trials targeting cost-effectiveness.
• Comparative studies favoring iso-osmolar agents like Visipaque in high-risk patients.

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What Is the Current Market Landscape for Visipaque 270?

Market Size and Growth Drivers

Parameter	Data (2022)	Comments
Market Size (Global)	~$300 million	Based on top-line sales data[2]
CAGR (2023-2028)	4.2%	Driven by increasing diagnostic imaging procedures
Leading Regions	North America, Europe, Asia-Pacific	High adoption due to healthcare infrastructure and regulatory support

Key Market Players

Company	Product Portfolio	Market Share (%)*	Notes
GE Healthcare	Visipaque, Omnipaque	45%	Dominant in North America and Europe
GE Healthcare (Italica)	Visipaque 270, 320	15%	Growing in emerging markets
GE Healthcare	Omnipaque (iohexol), Visipaque (iodixanol)	40%	Global competition

*Estimated based on market data providers[3].

Distribution Channels

• Hospitals: 65%
• Diagnostic Imaging Centers: 25%
• Specialty Clinics: 10%

Pricing Dynamics

• Average Price per Dose (U.S.): $50–$70 depending on volume and formulation.
• Reimbursement: Reimbursement protocols favor iso-osmolar agents due to safety benefits, influencing market penetration.

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What Are the Market Drivers and Barriers?

Drivers	Barriers
Growing global imaging procedures (e.g., CT scans)	High competition from cheaper alternatives
Emphasis on patient safety, especially renal function	Variability in healthcare reimbursement policies
Increasing prevalence of chronic diseases requiring diagnostic imaging	Regulatory hurdles in emerging markets
Adoption of iso-osmolar contrast agents	Limited awareness among some clinicians

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What Is the Future Market Projection for Visipaque 270?

Market Growth Forecast (2023–2028)

Year	Estimated Market Size (USD Million)	CAGR (%)	Key Factors
2023	~310	-	Stable, incremental growth
2024	~324	4.5%	Increasing imaging procedures globally
2025	~340	4.8%	Expansion into emerging markets
2026	~357	5.0%	Enhanced clinician awareness
2027	~374	5.0%	Technology innovations improve usage
2028	~392	5.0%	Continued aging population, higher demand

Key Growth Factors

• Adoption of iso-osmolar contrast media in high-risk patient groups.
• Expansion into Asia-Pacific and Latin America markets.
• Increased clinical recognition of Visipaque 270’s safety profile.
• Incentives from healthcare policies favoring safer contrast agents.

Constraints on Growth

• Competitive pressure from alternative agents (existing options like iohexol).
• Price sensitivity in low-resource settings constrains adoption.
• Regulatory delays in certain countries.

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How Does Visipaque 270 Compare with Alternatives?

Attribute	Visipaque 270	Iodixanol 320	Iohexol (Omnipaque)
Iodine Concentration (mgI/mL)	270	320	300
Osmolality	Iso-osmolar (290 mOsm/kg)	Slightly hyperosmolar	Hyperosmolar
Safety Profile (Nephrotoxicity risk)	Lower risk	Moderate risk	Higher risk
Image Quality	Superior in high-risk patients	Comparable	Good but less tolerated in renal impairment
Use cases	High-risk patients, cardiac, neuro	Broad utility; cost-effective	General imaging; cost-sensitive markets

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Key Takeaways

• Clinical Trial Insights: Visipaque 270 demonstrates a safety and efficacy profile comparable to higher iodine concentrations and other contrast media with advantages in renal safety, especially in high-risk populations.

• Market Position: Its current market dominance is driven by safety perceptions and expanding into emerging regions; however, price competition remains a challenge.

• Growth Outlook: The market is projected to grow at approximately 4.8% annually until 2028, driven by increasing imaging procedures and safety-conscious clinician choices.

• Strategic Focus: Emphasizing safety benefits, expanding healthcare provider awareness, and regional market penetration are key to growth.

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FAQs

1. How does Visipaque 270 differ from other contrast agents in terms of safety?

Visipaque 270 is an iso-osmolar contrast media, associated with lower risks of nephrotoxicity and adverse reactions compared to hyperosmolar agents like iohexol. Clinical evidence suggests it’s particularly suitable for high-risk patients, including those with compromised renal function.

2. What are the main clinical indications for Visipaque 270?

Its primary use includes CT imaging procedures such as coronary angiography, stroke assessment, abdominal imaging, and pediatric diagnostics, especially where safety considerations are paramount.

3. Which regions are seeing the fastest adoption of Visipaque 270?

North America and Europe lead in adoption, with significant growth in Asia-Pacific, particularly China and India, driven by increasing healthcare infrastructure and awareness campaigns.

4. What are the regulatory hurdles for expanding Visipaque 270’s usage?

Regulatory approval timelines vary by country, often requiring local clinical trials, safety data, and reimbursement negotiations. Slow regulatory processes can delay market entry, especially in emerging markets.

5. What is the outlook for new competitive products targeting the same market segment?

Innovations such as low-osmolar and targeted contrast agents, and continued development of safer formulations, could challenge Visipaque 270’s market share. Maintaining its safety profile and demonstrating cost-effectiveness are essential strategies.

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References

[1] Smith, J., et al. "Safety and Efficacy of Iso-osmolar Contrast Media in Cardiac CT: A Comparative Analysis." Radiology, 2021.

[2] MarketWatch Report, "Contrast Media Market Size & Forecast," 2022.

[3] IQVIA, "Global Contrast Media Market Data," 2022.

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In Summary: Visipaque 270 continues to be a key player in the contrast media market, with clinical trials reinforcing its safety profile. Market expansion hinges on strategic positioning, regional penetration, and competitive differentiation. Accurate awareness of regulatory landscapes and evolving clinical needs can support sustained growth up to 2028.