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
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

Last updated: July 28, 2026

Visipaque 270 (iodixanol) clinical trials update, market analysis, and market projection

Visipaque 270 (iodixanol 270 mg I/mL) is an established nonionic, dimeric iodinated contrast media used for intravascular and other radiographic imaging. The drug’s clinical-trials footprint is limited versus newer modalities, with incremental studies focused on safety, tolerability, and use in specific patient populations. Commercially, Visipaque faces ongoing generic and branded-contrast competition in multiple geographies; however, the exact market size and forward revenue projections depend on region-specific pricing, tender dynamics, and regulatory/shortage conditions for iodinated contrast.

No reliable, source-backed market sizing and near-term revenue projections can be produced from the information available in this session.

What clinical trials update exists for Visipaque 270 (iodixanol) and what are the latest outcomes?

What phases and study types show up most for iodixanol 270

Clinical research for iodixanol contrast is typically dominated by:

• Safety and tolerability in routine radiology settings
• Renal function outcomes in at-risk populations (contrast-associated acute kidney injury risk stratification)
• Comparison studies vs other nonionic iodinated contrast agents
• Pharmacovigilance and post-authorization observational datasets

What endpoints are usually reported

Studies of iodixanol products commonly use:

• Adverse event rates (overall and serious)
• Hemodynamic effects (where applicable)
• Renal biomarkers or clinically defined renal impairment
• Incidence of hypersensitivity-like reactions

Why “latest” trial updates are hard to translate into a single operational signal

Visipaque 270 is an off-patent, long-established agent in most markets, so trial activity is usually incremental rather than transformative. Without a verified list of the most recent studies and their readouts, a clinical-trials “update” cannot be stated in hard terms here.

How does Visipaque 270 perform versus other iodinated contrast agents in clinical outcomes and safety?

Nonionic dimer vs monomer comparisons

Clinically, iodixanol is positioned as a nonionic dimer with pharmacokinetic and tolerability attributes that drive clinician selection in higher-risk groups. Comparative evidence is usually measured against:

• Other nonionic monomers (e.g., iopamidol, iohexol, ioversol)
• Selection patterns by hospital protocols and formulary access

Renal safety and patient-selection claims

The strongest practical use-case discussions for iodixanol revolve around patients with:

• Pre-existing renal impairment
• Diabetes with renal risk factors
• Dehydration and other hemodynamic risk states

A quantified “how it performs” comparison requires specific, cited trial results, which are not available in this session.

What patents protect Visipaque 270 (iodixanol 270) and what is the exclusivity status?

Visipaque 270 is the marketed concentration product of iodixanol. For established iodinated contrast agents, patent estates often have expired or shifted to:

• Process and manufacturing-related claims
• Formulation and container/packaging improvements
• Method-of-use or specific labeling expansions (where pursued)

This session does not include a verified Orange Book listing or a patent family map, so a precise exclusivity and patent-expiration status for Visipaque 270 cannot be produced here.

What is the FDA regulatory status of Visipaque 270 and what labeling is implicated commercially?

For a full regulatory picture, a production-grade analysis uses:

• FDA Orange Book listings (drug substance, dosage form, exclusivity)
• Labeling content and changes (safety communications, boxed warnings if any, dosing/administration specifics)
• Device/drug combination considerations (if applicable)

No FDA Orange Book or labeling excerpts are available in this session, so the FDA status cannot be stated with the required hard-data rigor.

What market share and competitive landscape exists for Visipaque 270 in 2024–2026 by geography?

Who competes with Visipaque 270

Competitive pressure typically comes from:

• Branded iodixanol alternatives (where present by market)
• Generic iodinated contrast products at similar concentrations and osmolality profiles
• Hospital tenders that standardize across a limited formulary set

Key commercial drivers

Market dynamics generally track:

• Radiology volume trends
• Hospital purchasing and tender cycles
• Safety signals and guideline adherence in contrast dosing
• Supply availability for iodinated contrast (shortages can temporarily shift share)

This session lacks cited country-level market share, pricing, or procurement data, so quantified share allocation cannot be produced.

When does Visipaque 270 face major generic entry risk and Paragraph IV activity?

Paragraph IV filings apply to ANDA drug products tied to unexpired exclusivity or patents. For an established iodinated contrast agent, the main risk channels are:

• ANDA approvals for equivalent strengths
• Tender-driven substitution post-approval
• Any remaining secondary patents affecting specific packaging or methods

A paragraph-IV and generic-entry timeline requires Orange Book patent lists and legal dockets; none are present in this session.

How strong is the IP and litigation risk for Visipaque 270 (iodixanol) versus generic iodinated contrast?

IP risk depends on:

• Which patents remain in force for the specific listed strength and dosage form
• The scope of claim coverage (composition vs process vs packaging)
• Any ongoing district court or ITC proceedings

This session contains no patent docket or case identifiers, so no litigation risk assessment can be provided.

What are the revenue projections for Visipaque 270 through 2030 and what assumptions drive them?

No reliable revenue projections can be constructed here because this session lacks:

• Verified baseline revenue (global and by region)
• Current unit volumes and average selling prices
• Competitor substitution rates
• Regulatory and tender schedules
• Any confirmed forecast sources or cited financial benchmarks

Key commercial scenarios for Visipaque 270 (base, bull, bear)

Without source-backed baselines, scenarios cannot be quantified. The only hard, business-usable statements that would typically be forecasted are:

• Volume trend under imaging procedure growth
• ASP pressure due to generic entry and tender renegotiations
• Mix shifts (patient risk profile, imaging modality mix)
• Supply or shortage-related price spikes and later normalization

Quantification is not possible in this session.

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Key Takeaways

• Visipaque 270 is an established iodinated contrast medium; clinical activity is typically safety and tolerability focused.
• Patent and exclusivity status cannot be verified here at the required level for business decisions.
• Market sizing, share, and revenue forecasts require cited baseline and forecast inputs not available in this session.
• Competitive outcomes for iodinated contrast are driven largely by hospital tendering, supply conditions, and protocol standardization.

FAQs

1. What is Visipaque 270 (iodixanol 270 mg I/mL) used for clinically?
2. Does iodixanol 270 have advantages in patients at risk for contrast-associated acute kidney injury?
3. What are the main differences between Visipaque 270 and other nonionic iodinated contrast agents (e.g., iohexol, iopamidol)?
4. Is Visipaque 270 listed in the FDA Orange Book, and what patents are tied to the listed strength?
5. What factors most influence hospital switching from branded iodinated contrast to generics?

References (APA)

1. [No cited sources were provided in this session.]