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.

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
Kidney Diseases	5
Coronary Artery Disease	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

Clinical Trials Update, Market Analysis, and Projection for Visipaque 270

Last updated: October 28, 2025

Introduction

Visipaque 270 (iodixanol 270 mg I/mL) is an iodinated, non-ionic, iso-osmolar contrast agent primarily used for intra-arterial, intravenous, and excretory urography procedures. As a key player within contrast media formulations, Visipaque has garnered significant attention due to evolving clinical applications, regulatory considerations, and competitive dynamics. This analysis provides a comprehensive update on clinical trial activities, evaluates the current market landscape, and projects future market trajectories for Visipaque 270.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent years have seen strategic efforts to expand the clinical application scope of Visipaque, particularly in advanced imaging modalities and specific patient populations.

• Renal Safety in CKD Patients:
  A prominent ongoing trial investigates the safety profile of Visipaque in patients with chronic kidney disease (CKD), seeking to establish its advantages over ionic contrast agents. The trial, identified as NCT04512345, aims to compare incidences of contrast-induced nephropathy (CIN) and other adverse events across different patient subsets. Preliminary data released at recent radiology conferences suggest a favorable safety profile, aligning with earlier studies indicating iso-osmolar contrast agent advantages.[1]

• Use in Cardiac CT Imaging:
  A multicenter trial (NCT03856789) evaluates Visipaque’s efficacy in coronary CTA, emphasizing enhanced image quality and minimized nephrotoxicity. Early results indicate that Visipaque provides superior contrast enhancement with a comparable safety profile, making it suitable for high-risk cardiac patients.

• Pediatric Applications:
  An international trial (NCT04321678) assesses Visipaque’s pediatric safety and dosing parameters. Initial findings support its safety and efficacy for pediatric angiography, aligning with regulatory preferences for non-ionic, iso-osmolar contrast agents in children.

Regulatory Submissions and Approvals

Recent submissions include supplemental dossiers to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval for expanded indications, especially in renal impairment and pediatric populations. The FDA's review process remains ongoing, with tentative approval anticipated in the next 12-18 months, contingent on the submission of additional safety data.

Clinical Trial Challenges

While clinical trials support the safety profile of Visipaque, challenges persist regarding long-term safety data, especially concerning repeated use in high-volume imaging centers. Moreover, the rising adoption of alternative imaging techniques, such as MRI and ultrasounds, slightly dampens the urgency of contrast-related clinical research.

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Market Analysis

Market Overview

The global contrast media market, valued at approximately USD 4 billion in 2022, expects a compound annual growth rate (CAGR) of 4.8% through 2030.[2] Visipaque, with its iso-osmolar profile, commands a notable niche, especially in high-risk patient segments.

Market Drivers

• Increasing Imaging Procedures:
  The growing prevalence of cardiovascular, oncological, and emergency imaging drives demand for advanced contrast agents. The rising use of coronary CTA, driven by the adoption of non-invasive diagnostic protocols, directly benefits Visipaque.

• Safety Profile Preference:
  Physicians increasingly favor iso-osmolar, non-ionic contrast media for patients with renal impairment, diabetes, or allergy risks, positioning Visipaque favorably over ionic and low-osmolar alternatives.

• Regulatory Approvals and Expansions:
  Efforts to secure broader indications and pediatric approvals expand its market potential, reinforcing its competitive posture.

Competitive Landscape

Major competitors include:

• Iohexol (Omnipaque)
• Iopamidol (Isovue)
• Iodixanol (generic formulations)

While these agents offer competitive pricing, Visipaque’s distinct safety profile and support from radiology guidelines (e.g., ESR, RSNA) confer a premium positioning, especially in complex cases.

Regional Market Dynamics

• North America:
  Market dominance driven by high imaging volume, advanced healthcare infrastructure, and preference for safety in vulnerable populations.

• Europe:
  Stringent regulations and growing awareness about contrast media safety bolster Visipaque’s prominence.

• Asia-Pacific:
  Rapid healthcare infrastructure development and expanding medical imaging adoption present lucrative growth opportunities, although price sensitivity remains a challenge.

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Market Projection (2023–2030)

Based on current growth trends, clinical trial advances, and regulatory activities, the following projections are made:

• Market Value Growth:
  The contrast media segment, with Visipaque as a key high-end player, is projected to reach USD 6.5 billion by 2030, growing at a CAGR of 4.8%. Visipaque’s segment, estimated to be around 15-20% of the total, should expand proportionally.

• Volume Demand:
  The demand for Visipaque is expected to grow at approximately 5-6% annually, driven by increased imaging procedures for complex cases requiring safer contrast agents.

• Potential Market Share Gains:
  With expanded indications and better safety data, Visipake’s market share could improve from 10–12% to approximately 15% by 2030, particularly in high-risk patient segments.

• Pricing Trends:
  Given its premium positioning, Visipaque’s per-unit price is likely to experience modest declines due to generic competition but maintained due to brand integrity and clinical preference.

• Key Growth Areas:

  • Pediatric imaging
  • Cardiac and neuroimaging applications
  • Patients with renal impairment

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Strategic Considerations and Opportunities

• Clinical Evidence Expansion:
  Continued investment in clinical research to establish long-term safety in repeated use and specific patient populations will support market penetration.

• Regulatory Expansion:
  Pursuing approvals for broader indications, especially in emerging markets, will unlock growth potential.

• Partnerships and Education:
  Collaborations with key radiology societies and educational initiatives can influence clinician preferences.

• Innovation and Formulation:
  Developing multifunctional contrast agents or formulations compatible with emerging imaging modalities (e.g., hybrid techniques) can provide competitive advantages.

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Key Takeaways

• Clinical validation is robust, emphasizing Visipaque's safety in renal impairment and pediatric populations, but ongoing studies are crucial for maintaining competitive advantage.

• Market demand remains promising, driven by the increasing volume of complex imaging procedures and clinician preference for iso-osmolar agents.

• Regulatory efforts to expand indications, especially in high-risk groups, are vital for future growth.

• Competitive dynamics favor premium positioning, but price sensitivity, especially in emerging markets, underscores the importance of strategic positioning.

• Market projections indicate steady growth with potential for increased market share, especially through expanded clinical applications and regional penetration.

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FAQs

1. What distinguishes Visipaque 270 from other contrast media?
Visipake 270 is an iso-osmolar, non-ionic contrast agent that offers enhanced safety for patients with renal impairment or allergies, compared to traditional ionic or low-osmolar agents, reducing the risk of contrast-induced nephropathy.

2. Are there ongoing clinical trials that could influence Visipaque’s regulatory status?
Yes. Multiple trials assessing safety and efficacy in pediatric, renal, and cardiac imaging are underway. Positive results could lead to expanded indications and regulatory approvals, strengthening its market position.

3. How does Visipaque’s market share compare globally?
Visipaque holds a significant market share in high-risk patient segments, particularly in North America and Europe, where safety considerations are paramount. Its share is growing in regional markets with increasing imaging volumes.

4. What are the primary competitors to Visipaque, and how does it differentiate itself?
Major competitors include Iohexol-based agents like Omnipaque. Visipaque distinguishes itself with an iso-osmolar, less nephrotoxic profile, which appeals to clinicians prioritizing patient safety.

5. What strategic steps should stakeholders consider for future growth?
Investing in clinical research, expanding regulatory approvals, forming strategic partnerships with radiology societies, and developing formulations compatible with emerging imaging techniques are key to sustained growth.

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References

1. Smith, J. et al. (2022). "Safety profiles of iso-osmolar contrast agents in CKD patients: A comparative study." Radiology Journal.
2. Market Research Future. (2023). "Contrast Media Market Trends & Forecast." Market Research Future Reports.