CLINICAL TRIALS PROFILE FOR ISOVUE-370

All Clinical Trials for Isovue-370

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-370

Condition Name

Condition Name for Isovue-370
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Hypothyroidism	1
Pulmonary Embolism	1

Condition MeSH

Condition MeSH for Isovue-370
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Peripheral Arterial Disease	2
Arterial Occlusive Diseases	2

Clinical Trial Locations for Isovue-370

Trials by Country

Trials by Country for Isovue-370
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for Isovue-370
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for Isovue-370

Clinical Trial Phase

Clinical Trial Phase for Isovue-370
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Isovue-370
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Isovue-370

Sponsor Name

Sponsor Name for Isovue-370
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Quintiles, Inc.	2

Sponsor Type

Sponsor Type for Isovue-370
Sponsor	Trials
Industry	21
Other	9
NIH	1

ISOVUE-370 Clinical Trials Update and Market Outlook

Last updated: April 23, 2026

What is ISOVUE-370 and where does it sit in today’s therapy landscape?

ISOVUE-370 is a high-concentration iodinated contrast medium (370 mg iodine/mL) used to enhance imaging in CT and angiographic procedures. It is an established branded product in the radiology contrast segment and competes in a mature market with multiple therapeutically equivalent (i.e., same use case, comparable imaging performance) iodinated contrast products.

What does the clinical development pipeline currently show?

No active, product-specific late-stage (Phase 3 or registrational) clinical trials for ISOVUE-370 are identifiable as ongoing in public registries from the available record set used here. For an already marketed iodinated contrast, the practical clinical evidence base tends to be:

• Initial approvals and label-enabling studies completed years earlier
• Post-approval safety and utilization evidence, often reflected in pharmacovigilance, not in new Phase 3 registrational trials
• Manufacturing, process, and device-adjacent comparability studies that do not always appear as separate interventional “drug trials” on public platforms

Where do trial updates show up instead of new Phases?

For marketed contrast agents, the signal is typically driven by:

• Label updates (safety labeling refinements, administration guidance)
• Safety surveillance (adverse event reporting trends)
• Non-interventional observational research in practice settings

Because the request is for “clinical trials update” for ISOVUE-370, the operative conclusion from the available evidence record is that current activity is not dominated by new Phase 3 development announcements in public trial registries.

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What is the market structure for iodinated CT contrast today?

Segment overview

ISOVUE-370 operates inside the iodinated contrast market, with demand tied to:

• CT utilization growth (scan volume)
• Increasing imaging penetration in emergency and outpatient settings
• Protocol standardization (e.g., consistent contrast concentrations by indication)
• Hospital purchasing concentration and formulary placement

Competitive set (typical)

ISOVUE-370 competes against branded and authorized generic iodinated contrast agents at the same iodine concentration tier (where available), plus alternative dosing strategies (different concentrations, different volumes, different injection systems). Competitive differentiation usually hinges on:

• Image quality consistency claims
• Injection performance and viscosity/injection profile
• Packaging format and supply reliability
• Specialty distribution contracts

Pricing and access dynamics

In mature, procurement-led imaging categories:

• Contract pricing and formulary status drive volume more than incremental clinical differentiation.
• WAC-to-net spreads are typically governed by hospital group contracting and rebates.
• Generic entry or authorized generics can compress branded price points over time in specific channels.

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What demand drivers support ISOVUE-370 through the next 3 to 5 years?

ISOVUE-370’s demand is primarily a function of imaging volume and protocol preference rather than new clinical endpoints. Key demand drivers typically include:

• Continued CT volume growth: more scans per patient and expanding indications in ED and oncology workflows
• Inelastic substitution in institutional practice: once a radiology department standardizes contrast products, switching friction persists
• High throughput imaging operations: preference for agents with reliable injection handling and consistent supply
• Risk management protocols: contrast is embedded in standardized pathways for vascular and abdominal imaging

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How should you think about market projection for ISOVUE-370 specifically?

Projection framework (market rather than molecule)

For established contrast products, projection is better anchored on category-level imaging demand plus brand-specific share retention. A practical projection approach:

1. Start with iodinated CT contrast category growth tied to CT scan growth
2. Apply a share retention assumption for ISOVUE-370 within its concentration tier
3. Adjust for pricing compression from authorized generics and contracting
4. Consider supply and distribution stability as a revenue protection factor

Expected shape of growth

Given the maturity of iodinated contrast markets:

• Revenue growth is expected to track mostly with utilization rather than unit expansion
• Price erosion risk is material, even when utilization grows
• Net growth can become “flat to modest” if category growth is offset by contracting-driven price compression

Business case implication

For investment and R&D prioritization, ISOVUE-370 is best treated as:

• A cash-flow anchored, procurement-dependent product
• Less exposed to “trial-driven” upside
• More exposed to payer/provider contracting, supply economics, and competitor portfolio moves

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What are the key risks to the ISOVUE-370 market outlook?

1. Net price compression from competing brands and authorized generics
   • Hospital contracting can force down effective price even if WAC remains stable.
2. Formulary switching and concentration tier changes
   • Departments may adjust protocols or switch products based on injection performance, volume requirements, or contract terms.
3. Safety and tolerability perceptions
   • While serious reactions are known across the class, label refinements and public safety attention can alter utilization patterns and premedication behaviors.
4. Regulatory or manufacturing continuity
   • Contrast supply is sensitive to manufacturing continuity. Any disruption can shift usage temporarily, affecting share.

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What do “clinical trials updates” mean for ISOVUE-370 holders today?

Because no clear new Phase 3/registrational activity is indicated in public records, “updates” for ISOVUE-370 typically take these forms:

• Current label language and safety warnings that affect institutional protocols
• Post-marketing safety reporting patterns that inform risk management guidance
• Observational utilization studies that inform real-world protocol preferences

For a business decision, these updates impact uptake indirectly, through contracting and protocol adoption rather than directly through new efficacy readouts.

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Key Takeaways

• ISOVUE-370 is a mature, marketed iodinated CT contrast (370 mg iodine/mL) with demand driven primarily by imaging utilization and institutional procurement.
• Public records do not show an active, registrational Phase 3 trial pattern for ISOVUE-370 as of the available evidence set used here; clinical “updates” are more likely to appear as label refinements, safety surveillance, and observational utilization work.
• Market projection should be framed as category utilization growth plus brand share retention, offset by ongoing pricing pressure from contracting and authorized generics.
• The main outlook drivers are CT volume growth and formulary stability; the main risks are net price compression, concentration-tier protocol shifts, and supply continuity.

FAQs

1) Is ISOVUE-370 in Phase 3 development today?
No clear active Phase 3 registrational program for ISOVUE-370 is identifiable from publicly available trial records used for this update.

2) What drives ISOVUE-370 revenue most: clinical endpoints or imaging volume?
Imaging volume and institutional purchasing behavior drive utilization; clinical endpoints are not the primary driver in a mature contrast segment.

3) What market risks matter most for iodinated contrast products like ISOVUE-370?
Net price compression from competition and authorized generics, formulary switching, and any supply or manufacturing continuity issues.

4) How should a projection model handle ISOVUE-370?
Anchor to iodinated CT contrast category growth, apply share retention within its concentration tier, then apply pricing compression from contracting.

5) Where do clinical trial “updates” typically show up for already marketed contrast agents?
Safety surveillance, label refinements, and observational practice studies rather than new Phase 3 efficacy trials.

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References

[1] FDA. (n.d.). Drug trials snapshots and related review artifacts for contrast media. U.S. Food and Drug Administration.
[2] ClinicalTrials.gov. (n.d.). ISOVUE-370 trial search results. U.S. National Library of Medicine.
[3] Radiological Society of North America (RSNA). (n.d.). CT contrast and iodinated contrast utilization educational and clinical practice resources.