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.

Clinical Trial Conditions for VISIPAQUE 270

Condition Name

Condition Name for VISIPAQUE 270
Intervention	Trials
Coronary Artery Disease	5
Cardio-Renal Syndrome	2
Peripheral Arterial Occlusive Disease	2
Diabetes Mellitus	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
India	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 Market Analysis and Financial Projection

Last updated: April 27, 2026

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

Visipaque 270 (iopamidol injection; 270 mg iodine/mL) is a mature, off-patent iodinated contrast agent with broad imaging use across computed tomography (CT), angiography, and related radiology workflows. Current opportunities are driven less by new clinical breakthroughs and more by supply continuity, formulary access, contracting, imaging-volume growth, and substitution dynamics within the iodinated contrast class.

What is the clinical trial activity for Visipaque 270?

There is no robust, current, registrational-grade signal for Visipaque 270-specific Phase 3 or pivotal new use studies in the public trial registries. Published clinical evidence and label-informed data support its established indications and dosing paradigms across adult and pediatric CT and angiographic imaging, with ongoing industry behavior shifting toward:

• Comparative formulary and contracting studies (often small or retrospective),
• Device and workflow compatibility studies (catheter/administration workflows),
• Post-marketing safety surveillance rather than new efficacy endpoints.

What dosing/label context anchors current clinical use?

Label usage patterns for iopamidol 270 mg I/mL generally align with established iodinated contrast administration ranges used in:

• CT (intravascular/intravenous): typical bolus and injection protocols vary by indication and patient factors.
• Angiography (intra-arterial/intravascular): dose and dilution depend on procedure, vascular territory, and imaging goals.

(Visipaque is the registered brand name for iopamidol injection in multiple regions; dosing language is in region-specific prescribing information. The clinical relevance for new trials is that the product is already positioned for established indications rather than new mechanism-driven claims.)

How does Visipaque 270 fit into the modern iodinated contrast market?

Market structure

Iodinated contrast media (ICM) is a high-volume, highly substitutable category. Brand value depends on:

• Local regulatory status and label breadth,
• Tender competitiveness and wholesaler contracts,
• Supply reliability and manufacturing capacity,
• Adherence to current administration standards and patient safety monitoring.

Competitive set

Visipaque competes in broad market segments against other nonionic, low-osmolality iodinated contrast agents (LOCM) and, in some settings, alternative classes depending on national procurement preferences. In practice, selection is driven by:

• Price-to-volume and tender outcomes,
• Formulary restrictions (often based on hospital-specific procurement cycles),
• Product availability and logistics,
• Clinician preference shaped by historical outcomes and institutional experience.

Key market drivers

The main drivers for demand and pricing are not new clinical outcomes for Visipaque, but:

• Growth in CT volumes globally,
• Hospital imaging expansion and throughput targets,
• Ongoing use of ICM in angiography and interventional radiology,
• Procurement centralization that favors cost-effective supply.

Key headwinds

• Increased generic and alternate-brand penetration in many markets,
• Tender pressure compressing gross margins,
• Regulatory and pharmacovigilance overhead without new registrational upside.

What is the near- to mid-term market outlook for Visipaque 270?

Projection logic (category-level)

For a mature, off-patent ICM brand, projection should follow ICM category volume growth and share stability rather than R&D-driven revenue uplift. A practical projection model uses three levers:

1. Imaging demand growth (CT and interventional procedures),
2. Share and tender retention within iodinated contrast portfolios,
3. Net price realization after discounts.

Business-relevant projection ranges

Because the product is mature and substitutions are strong, the plausible range for revenue growth depends on whether Visipaque retains share versus competing products during procurement cycles. In most markets, the pattern for mature ICM brands is:

• Volume-supported growth aligned with imaging utilization,
• Limited or modest net price increases (often net price declines offset volume gains),
• Share fluctuations driven by tender outcomes and supply continuity.

Base case (typical mature ICM pattern)

• Revenue: tracks roughly with category volume growth, with modest net price pressure.
• EBITDA margin: stable to slightly down if tender pressure increases or if input costs rise faster than net price.

Upside case (contract wins / supply stability)

• Revenue: exceeds category growth due to share gains in hospital systems and radiology networks.
• Margin: improves if premium formulary positioning holds and procurement yields favorable terms.

Downside case (tender displacement / supply disruptions)

• Revenue: grows slower than the category or declines if replaced at large accounts.
• Margin: compresses due to heavier discounting and increased logistics costs.

What clinical evidence supports continued payer and clinician acceptance?

Established safety and effectiveness profile

Iopamidol is supported by longstanding clinical use and a large body of routine imaging practice. For mature ICM brands, the clinical requirement for continued adoption usually centers on:

• Safety monitoring practices (contrast-associated risks, renal considerations),
• Consistency of imaging quality and workflow fit,
• Compatibility with standard administration settings used in radiology departments.

Practical adoption criteria

Hospital adoption remains tied to:

• Standard operating procedures for hydration and risk stratification,
• Availability of protocols for dose selection and administration,
• Pharmacy and therapeutics committee decisions anchored to local data and tender economics.

What should investors and R&D leaders watch next?

Patent and exclusivity status

Visipaque is a brand-level product in a mature molecule category. The value driver is not new exclusivity but asset protection at the product and supply chain level, such as:

• Brand life-cycle management,
• Regional formulation and packaging variations (where applicable),
• Continued regulatory compliance and pharmacovigilance performance.

Commercial watchpoints

• Next major hospital contracting rounds in target geographies,
• Manufacturing or supply continuity signals,
• Substitution behavior in large radiology networks.

Market numbers: what can be quantified from public sources?

A complete numeric forecast for Visipaque 270 specifically requires product-level revenue reporting, geography-specific tender data, and channel pricing that are not available in a single consolidated public dataset in a way that supports a complete, accurate projection.

Key Takeaways

• Visipaque 270 is a mature iopamidol (270 mg I/mL) iodinated contrast brand with mature clinical positioning and no clear registrational-grade new trial pipeline signal in public registries.
• Demand is driven by imaging volume growth (CT and interventional radiology) and procurement execution, not by new efficacy breakthroughs.
• Near-term revenue outlook follows iodinated contrast category volume with net price pressure as the key risk factor.
• The investment and business battleground is hospital contracting, supply continuity, and share stability versus alternate brands in the iodinated contrast class.

FAQs

1. Is Visipaque 270 in late-stage clinical development for a new indication?
   Public evidence does not show a clear, registrational-grade Phase 3 or pivotal program for Visipaque 270 specifically.

2. What drives Visipaque 270 demand most?
   CT and interventional imaging volumes plus hospital procurement and tender outcomes within the iodinated contrast class.

3. How competitive is the iodinated contrast market for Visipaque?
   Highly substitutable, with selection usually determined by tender pricing, availability, and institutional protocols.

4. Does Visipaque 270 face patent-based growth headwinds?
   As an off-patent molecule class, growth depends on brand retention and commercial execution rather than exclusivity expansion.

5. What would change the market trajectory for Visipaque 270?
   Significant shifts in hospital formulary decisions, large contract wins or losses, or major supply continuity events.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. Study records for iopamidol/Visipaque (accessed 2026-04-28). https://clinicaltrials.gov/
[2] DailyMed. Visipaque (iopamidol) prescribing information (varies by country/label version; accessed 2026-04-28). https://dailymed.nlm.nih.gov/
[3] U.S. Food and Drug Administration. Drug Approval and Labeling information for iopamidol-containing products (accessed 2026-04-28). https://www.accessdata.fda.gov/