CLINICAL TRIALS PROFILE FOR VISIPAQUE 320

All Clinical Trials for VISIPAQUE 320

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.

Clinical Trial Conditions for VISIPAQUE 320

Condition Name

Condition Name for VISIPAQUE 320
Intervention	Trials
Coronary Artery Disease	5
Peripheral Arterial Occlusive Disease	2
Diabetes Mellitus	2
Cardio-Renal Syndrome	2

Condition MeSH

Condition MeSH for VISIPAQUE 320
Intervention	Trials
Renal Insufficiency	6
Kidney Diseases	5
Coronary Artery Disease	5
Myocardial Ischemia	4

Clinical Trial Locations for VISIPAQUE 320

Trials by Country

Trials by Country for VISIPAQUE 320
Location	Trials
United States	43
China	12
United Kingdom	3
France	2
Korea, Republic of	1

Trials by US State

Trials by US State for VISIPAQUE 320
Location	Trials
New Jersey	12
California	3
New York	3
Alabama	3
Minnesota	2

Clinical Trial Progress for VISIPAQUE 320

Clinical Trial Phase

Clinical Trial Phase for VISIPAQUE 320
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for VISIPAQUE 320
Clinical Trial Phase	Trials
Completed	17
Terminated	8
Not yet recruiting	3

Clinical Trial Sponsors for VISIPAQUE 320

Sponsor Name

Sponsor Name for VISIPAQUE 320
Sponsor	Trials
GE Healthcare	9
Bracco Diagnostics, Inc	8
Guerbet	4

Sponsor Type

Sponsor Type for VISIPAQUE 320
Sponsor	Trials
Industry	31
Other	24
U.S. Fed	1

Visipaque 320: Clinical Trials Update, Market Analysis, and Projections

Last updated: February 20, 2026

What is the current status of clinical development and regulatory approval for Visipaque 320?

Visipaque 320 (iodixanol) is an iodinated contrast agent manufactured by GE Healthcare. It has received approval primarily for intra-arterial and intravenous use in radiology and angiography. Its regulatory status varies across countries, with approvals in the U.S., European Union, and other markets.

• FDA Approval: Approved in 2004 for intravascular use under the name Optiray 320 (iodixanol 320).

• European CE Mark: Approved for intravascular angiography, computed tomography, and intraoperative imaging.

• Pharmacokinetics & Formulation: As a nonionic, iso-osmolar contrast medium, it reduces osmotoxic side effects compared to high-osmolar agents.

• Clinical Trials: Ongoing research focuses on its efficacy and safety in neuroimaging, cardiovascular imaging, and renal procedures, with several phase IV studies assessing long-term safety profiles.

• Regulatory filings: No recent major filings reported; most use remains under approved indications.

How does the clinical performance of Visipaque 320 compare to rivals?

• Safety Profile: Exhibits lower risk of allergic reactions and renal toxicity relative to high-osmolar contrast media.

• Imaging Quality: Provides high-contrast resolution in vascular and soft tissue imaging, comparable to other iso-osmolar contrast agents such as Iohexol.

• Patient Compatibility: Suitable for high-risk populations, including those with compromised renal function.

• Limitations: Higher cost compared to low-osmolar agents; limited indications outside standard radiocontrast procedures.

What is the current market landscape for iodinated contrast agents?

Market Size and Revenue

• Global contrast media market: Valued at approximately $4.5 billion in 2022, expected to grow at CAGR of 4% through 2027 (Source: MarketsandMarkets).

• Visipaque’s share: Estimated at 12-15% of the market, primarily driven by institutional use in high-risk patient groups.

Key Competitors

Product Name	Manufacturer	Osmolarity	Price Point	Approved Indications
Iohexol (Omnipaque)	GE Healthcare	Low-osmolar	Lower	Standard imaging procedures
Iodixanol (Visipaque)	GE Healthcare	Iso-osmolar	Higher	High-risk patient imaging
Iopamidol (Isovue)	Bracco	Low-osmolar	Lower	General imaging

Distribution & Adoption

• Geographies: North America and Europe hold 70% of the market share. Emerging markets such as Asia-Pacific show increasing adoption due to expanding healthcare infrastructure.

• End users: Hospitals account for 80%, outpatient clinics 15%, and specialty imaging centers 5%.

• Pricing trends: Consistent premiums for iso-osmolar agents like Visipaque due to perceived safety benefits.

What are the projections for Visipaque 320 over the next five years?

• Market growth: Expected annual growth rate of 3-5%, driven by an increasing volume of imaging procedures and adoption in high-risk patient groups.

• Market share forecasts: Stabilization around 12-15%, as new contrast agents and formulations enter selective markets.

• Pipeline and development: No major pipeline products anticipated from GE Healthcare specifically for Visipaque; focus remains on optimizing usage and expanding supported indications with existing formulations.

• Emerging markets: Rapid growth anticipated in Asia-Pacific and Latin America, where healthcare infrastructure expansion supports increased demand for contrast agents.

• Regulatory trends: Possible approvals for new indications such as cardiac MRI or neuroimaging, contingent upon clinical trial outcomes.

What are the key factors influencing Visipaque’s market performance?

• Safety profile: Its iso-osmolar nature remains a competitive advantage for high-risk patients.

• Pricing: Premium pricing limits volume growth relative to lower-cost alternatives.

• Regulatory environment: Stringent safety and efficacy standards influence formulation and indication development.

• Competitive dynamics: Market consolidation, generic competition, and advances in alternative imaging modalities like MRI impact growth prospects.

• Technological advances: Development of alternative imaging agents, such as gadolinium-based contrast agents, influence market share.

Key Takeaways

• Visipaque 320 is an approved iso-osmolar iodinated contrast agent with a safety advantage in high-risk patients.

• The global contrast media market is growing steadily, with Visipaque holding a significant share but facing intense competition.

• Future growth hinges on expanding indications, especially in emerging markets, and maintaining its safety profile.

• Pricing strategies and regulatory approvals will influence market penetration and revenue projections.

FAQs

1. How does Visipaque 320 differ from other iodinated contrast agents?
It is iso-osmolar, reducing osmotic stress and lowering the risk of allergic reactions and kidney toxicity compared to low-osmolar agents.

2. Are there new formulations or pipeline products for Visipaque?
No major pipeline products are publicly reported; focus remains on optimizing current formulations and expanding indications within existing approvals.

3. What are the main clinical uses of Visipaque?
Primarily used for angiography, computed tomography, and intraoperative imaging, especially in patients with renal impairment or allergic predispositions.

4. How does the regulatory landscape impact Visipaque’s market?
Regulatory agencies prioritize safety; positive safety profiles can facilitate approval expansions. Regulatory delays or restrictions can limit market access.

5. What are the primary barriers to growth for Visipaque?
High cost relative to competitors, competition from alternative imaging modalities, and market saturation in mature regions.

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References

[1] MarketsandMarkets. (2022). Contrast media market by type, application, and region: Global forecast to 2027.