CLINICAL TRIALS PROFILE FOR ISOVUE-M 300

All Clinical Trials for ISOVUE-M 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.

Clinical Trial Conditions for ISOVUE-M 300

Condition Name

Condition Name for ISOVUE-M 300
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Moderate to Severe Chronic Kidney Disease	1
Coronary Artery Disease	1

Condition MeSH

Condition MeSH for ISOVUE-M 300
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Renal Insufficiency, Chronic	2
Peripheral Arterial Disease	2

Clinical Trial Locations for ISOVUE-M 300

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for ISOVUE-M 300

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for ISOVUE-M 300

Sponsor Name

Sponsor Name for ISOVUE-M 300
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Quintiles, Inc.	2

Sponsor Type

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

Last updated: May 22, 2026

ISOVUE-M 300 clinical trials update, market analysis and exclusivity/patent outlook

Executive summary: ISOVUE-M 300 (iopamidol injection; 300 mg iodine/mL) is an iodinated contrast medium marketed in the US for X‑ray imaging. Its near-term commercial outlook is driven by hospital demand for routine contrast-enhanced CT and angiography workflows, supply stability for generic/authorized generics of iopamidol, and regulatory continuity rather than a new-wave pipeline. Publicly visible “clinical trials updates” for ISOVUE-M 300 specifically are limited because the product is an established reference-brand formulation with an older active ingredient. The most actionable IP and competition risk is the baseline iopamidol patent landscape plus any formulation/device-specific exclusivities for the labeled presentation (dose volume and container configuration), rather than new clinical endpoints that would materially expand the indication base.

What is ISOVUE-M 300 and what is the current clinical evidence base?

ISOVUE-M 300 is iopamidol injection (300 mg iodine/mL). As an iodinated contrast medium, its clinical “evidence base” is dominated by historical comparative imaging performance and safety characterization typical for intravascular contrast agents, including hypersensitivity and nephrotoxicity risk management.

What this means for “clinical trials update” searches

• The dominant ongoing activity is often post-marketing surveillance and label maintenance rather than brand-specific late-stage trials.
• For established contrast agents, manufacturers typically run either (1) bioavailability/presentation bridging studies for generics and authorized generics, or (2) observational studies and registry analyses tied to imaging utilization and safety signals.

Where would new ISOVUE-M 300 trials show up, if any exist

High-intent searchers usually look for:

• NCT records containing “iopamidol” and the specific brand string “ISOVUE-M 300”
• FDA label update citations tied to new contraindications/warnings/adjunct use
• Manufacturer press releases tied to new dosing regimens or new container formats

Actionable take: without a visible, product-specific interventional trial signal, the most reliable “clinical update” signal for ISOVUE-M 300 is regulatory label continuity plus imaging utilization trends rather than a late-stage pipeline event.

Are there active clinical trials for iopamidol 300 mg I/mL that affect ISOVUE-M 300 demand?

For commercial planning, the key is whether trials target:

• broader imaging indications (changing volume utilization)
• lower-volume or patient-specific dosing that can shift per-scan iodine consumption
• reduced hypersensitivity risk protocols that affect purchasing decisions

Featured snippet answer: No product-level, ISOVUE-M 300-specific late-stage trials are clearly identifiable as a demand-shaping driver from publicly indexed signals for an established iopamidol contrast agent; the commercial effect is more often driven by generic/authorized generic competition and hospital purchasing.

Trial types most likely to move the needle

• Imaging protocol studies (dose optimization, injection rate, timing)
• Safety studies (breakthrough hypersensitivity characterization, premedication effectiveness)
• Renal safety work tied to contrast-associated acute kidney injury (CA-AKI) guidelines

What is the market size and demand driver for iopamidol 300 mg I/mL (ISOVUE-M 300 category)?

Demand drivers

• CT utilization and angiography procedure volumes
• Hospital conversion to higher-throughput scanners and standardized contrast protocols
• Seasonal and staffing effects on imaging throughput
• Procurement cycles and multi-source contracting for iodinated contrast

Key category dynamic Iodinated contrast is a competitive, high-volume hospital spend category where multiple manufacturers supply the same strength range. For iopamidol 300 mg I/mL, procurement tends to price aggressively, with reference-brand share compressed by authorized generics and multiple ANDA entrants over time.

Commercial variables that govern ISOVUE-M 300 projections

• Contracting position: whether ISOVUE-M 300 is in sole-source, preferred, or substitutable tiers
• Average unit price vs category basket (private label and generic substitution)
• Supply reliability and allocation risk (contrast agents are operationally sensitive)
• Conversion based on formulary and injection system compatibility
• Utilization per procedure (protocol-driven iodine volume per scan)

How do generic iopamidol products affect ISOVUE-M 300 revenue and pricing?

Featured snippet answer: ISOVUE-M 300 faces structural pricing pressure from generic iopamidol 300 mg I/mL equivalents and authorized generics, with hospital formularies substituting at the product-line level rather than by brand.

What to track in competitive landscape

• FDA approval announcements and labeling parity (same concentration, similar indications and administration guidance)
• Contract awards by IDNs (integrated delivery networks) and GPO tenders
• Stocking preferences for container types (vial sizes, carton configuration) and compatibility with power injectors

When does ISOVUE-M 300 lose exclusivity, and what patents matter?

Featured snippet answer: ISOVUE-M 300 exclusivity is primarily constrained by the age of the iopamidol reference active ingredient and by the expiration of any formulation, method-of-use, and packaging patents that cover the specific labeled product presentation.

Commercially relevant patent question: “Is there any enforceable, product-specific patent that prevents generic iopamidol 300 mg I/mL ANDAs from launching?”

Patent estate structure to evaluate

For established injectables like iopamidol:

1. Active ingredient (core composition) patents: mostly expired for older radiographic contrast agents.
2. Formulation patents: may cover specific concentration ranges, stabilizers, or processing parameters.
3. Method-of-use patents: less common for broad imaging contrast use but can exist for patient subgroups or procedural steps.
4. Packaging and container closure systems: can delay entry for particular presentation SKUs.
5. Orange Book-listed “Drug Product” patents: drive Paragraph IV risks in the ANDA context.

What is the Orange Book status of ISOVUE-M 300 and which patents are listed?

A complete Orange Book mapping requires a product-level Orange Book extract (drug name, dosage form, strength, and listed patents with expiration). That mapping is not present in the information provided in this prompt.

Which companies challenge iopamidol 300 mg I/mL via Paragraph IV, and what litigation affects launch timing?

A complete Paragraph IV and litigation view also requires case-level data tied to specific ANDAs/Orange Book listings for iopamidol 300 mg I/mL presentations. That dataset is not present in the information provided in this prompt.

What generic entry risks exist for ISOVUE-M 300 in the US?

Generic entry risks for established contrast agents typically hinge on:

• Orange Book “drug product” and “drug substance” patent coverage at the exact strength and dosage form
• Whether any remaining, non-expired patents relate to the specific container/pack
• Whether FDA designates any required pediatric exclusivity or other listed exclusivity periods (less common for older molecules)

Featured snippet answer: For iopamidol 300 mg I/mL, the dominant US entry risk is not clinical uncertainty but patent clearance around any still-listed formulation/packaging patents for the specific branded presentation.

How does ISOVUE-M 300 compare with other iodinated contrast agents and does it substitute across classes?

Category substitution

• Iodixanol, iohexol, ioversol, and other iodinated nonionic contrast agents compete by formulary preference, cost, tolerability, and imaging workflow fit.
• Hospitals switch among agents based on GPO and IDN contracts, often treating them as interchangeable for many routine CT indications.

Purchasing effect on projections: Even if iopamidol 300 mg I/mL is reference-stable, substitution by other nonionic agents can depress brand share if price differentials widen.

How do FDA regulatory milestones affect ISOVUE-M 300 manufacturing and supply projections?

For mature injectables:

• Manufacturing changes, inspections, and site approvals are often the largest operational drivers of short-term supply stability.
• Label maintenance updates typically do not materially expand utilization but can change prescribing patterns via warnings and administration guidance.

Featured snippet answer: Supply continuity and procurement contracts usually dominate short-horizon market projections for ISOVUE-M 300.

What are the key commercial KPIs to model for ISOVUE-M 300 over the next 3 to 5 years?

Use a bottom-up hospital procurement model:

• Demand volume: imaging procedure volume proxies (CT angiography and contrast-enhanced CT share)
• Dose utilization: average mL per procedure and repeat dosing rates
• Net price: list price minus rebates, discounts, and GPO outcomes
• Mix: vial size and container configuration that influences wastage and purchasing
• Share: reference brand share vs authorized generics vs competing branded nonionics
• Supply constraints: allocation risk and backorder effects on contract compliance

Projection mechanics

• Base case: stable procedure demand growth with gradual erosion of brand net price through competitive contracting
• Bear case: accelerated substitution to lower-cost alternatives or supply disruptions
• Bull case: contract wins that lock preferred status across a major IDN cluster

Key Takeaways

• ISOVUE-M 300 is an established iopamidol-based iodinated contrast medium; “clinical trial update” relevance is typically limited because product-specific late-stage trials are uncommon for mature contrast agents.
• Market performance is driven primarily by hospital procurement, pricing pressure from generic/authorized generic iopamidol 300 mg I/mL equivalents, and cross-agent substitution among nonionic iodinated contrasts.
• The highest business-risk driver is IP and regulatory status tied to Orange Book-listed patents and any remaining enforceable drug product/formulation/packaging protections for the specific branded presentation, not new clinical evidence.
• Near-term commercial projections should be modeled using demand proxies, dose utilization, net price trajectory under contracting pressure, and supply continuity.

FAQs

1. What is the typical dosing workflow for ISOVUE-M 300 in contrast-enhanced CT, and what factors change mL per scan?
2. How do hospital formulary tiering and GPO contracts typically shift iopamidol 300 mg I/mL share to generics or competing nonionics?
3. What labeling safety warnings for iodinated contrast most influence prescribing choices (e.g., hypersensitivity and renal risk workflows)?
4. How can container/vial size and power-injector compatibility affect wastage and procurement decisions for iopamidol 300 mg I/mL?
5. What operational risks (CMC, inspections, supply allocation) most often disrupt iodinated contrast availability for major US brands?

References

1. Food and Drug Administration. Approved Drug Products and Databases (Orange Book). FDA.
2. Food and Drug Administration. Drug Trials Snapshots and Drug Approval Reports. FDA.
3. ClinicalTrials.gov. iopamidol trials listings. National Library of Medicine.