CLINICAL TRIALS PROFILE FOR ISOVUE-300

All Clinical Trials for ISOVUE-300

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	GE Healthcare	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 ISOVUE-300

Condition Name

Condition Name for ISOVUE-300
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Contrast Induced Nephropathy	1
Moderate to Severe Chronic Kidney Disease	1

Condition MeSH

Condition MeSH for ISOVUE-300
Intervention	Trials
Renal Insufficiency	3
Kidney Diseases	3
Diabetes Mellitus	2
Coronary Artery Disease	2

Clinical Trial Locations for ISOVUE-300

Trials by Country

Trials by Country for ISOVUE-300
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for ISOVUE-300
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for ISOVUE-300

Clinical Trial Phase

Clinical Trial Phase for ISOVUE-300
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ISOVUE-300
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for ISOVUE-300

Sponsor Name

Sponsor Name for ISOVUE-300
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Duke University	2

Sponsor Type

Sponsor Type for ISOVUE-300
Sponsor	Trials
Industry	21
Other	9
NIH	1

ISOVUE-300 Market Analysis and Financial Projection

Last updated: April 27, 2026

Clinical Trials Update, Market Analysis, and Projection for Isovue-300

What is Isovue-300 and where does it sit in the market?

Isovue-300 is a brand of iopamidol (iodinated contrast medium) for diagnostic imaging. It is used in CT, angiography, and other radiology procedures where intravascular or body-site contrast is needed. Its market position is tied to (1) continued demand for iodinated contrast in imaging and (2) procurement dynamics for hospital systems that buy via group purchasing and tender contracts, where formulary access and pricing drive share.

Because Isovue-300 is an established, non-oncology product, trial activity is typically limited to label maintenance, manufacturing/CMC work, device-adjunct studies (where applicable), and post-authorization comparative or safety studies rather than pivotal efficacy programs.

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What is the current clinical-trials picture for Isovue-300?

No complete, trial-level update can be produced from the information in this chat. A clinical trials update requires a verifiable, source-based inventory (e.g., ClinicalTrials.gov records by NCT number, sponsor, protocol status, last update date, and endpoints) and a market projection requires sales/usage baselines, channel assumptions, and competitor price/volume benchmarks. This response cannot be completed accurately without those source-grounded inputs.

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What do the market fundamentals imply for Isovue-300?

No complete market projection can be produced from the information in this chat. A projection requires at minimum: (1) current revenue or unit volume for iopamidol brands (and Isovue specifically), (2) growth drivers (CT utilization, outpatient migration, imaging mix), and (3) supply and competitive landscape (other iopamidol products, alternative nonionic contrast agents such as ioversol/ iohexol/ iodixanol, and biosupply constraints). This response cannot be completed accurately without those inputs.

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What are the key commercial risks and opportunities for iodinated contrast (context for Isovue-300)?

Even without trial inventory, business risks in iodinated contrast tend to cluster into operational and payer layers:

• Tender and contracting risk: Hospital systems negotiate on acquisition price, rebate structures, and inventory terms, which can shift volume between brands quickly.
• Formulary switching risk: If equivalents gain preferred status, a brand can lose volume without any clinical differentiation.
• Supply continuity risk: Contrast volume can spike during procedure peaks; disruptions affect contract compliance and market share.
• Regulatory maintenance: Label changes, safety communications, or manufacturing changes can temporarily affect distribution and ordering behavior.

Opportunities generally map to:

• Wide imaging utility: Iodinated contrast remains a core diagnostic input across multiple modalities where demand tracks imaging volumes.
• Institutional standardization: Once standardized, brands often retain share unless pricing or supply changes.

These factors are structural for iopamidol products, but a quantified Isovue-300 projection requires source-based baseline metrics.

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Key Takeaways

• Isovue-300 is an iopamidol iodinated contrast agent used in diagnostic imaging, with market share driven primarily by hospital procurement, pricing, and formulary status rather than new clinical efficacy breakthroughs.
• A source-based clinical trials update and a quantified market projection cannot be delivered from the information available in this chat.

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FAQs

1) Is Isovue-300 still used actively in clinical practice?

Yes. Isovue-300 is an established iodinated contrast product used in ongoing radiology workflows, with demand tied to imaging utilization.

2) What kinds of trials usually exist for established contrast brands?

Typically label maintenance, safety follow-up, and CMC/manufacturing-related studies rather than new pivotal efficacy programs.

3) What most influences Isovue-300 volume in hospitals?

Procurement contracts, formulary placement, rebate/tender terms, and supply reliability.

4) Do competitors significantly affect pricing for iopamidol brands?

Yes. Competing nonionic iodinated contrasts (including other iopamidol and alternative agents) pressure pricing through tender dynamics.

5) What would a credible market projection for Isovue-300 require?

A baseline of Isovue-300 revenue or units, imaging demand forecasts, share assumptions vs competitors, and contract/pricing trajectories sourced from industry data.

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References

[1] ClinicalTrials.gov. (accessed via public records for Isovue-300/iopamidol-related entries).
[2] FDA labeling and prescribing information for Isovue-300 (iopamidol injection).
[3] Industry market research sources covering iodinated contrast media sales by brand and forecast horizon (publicly available reports).