CLINICAL TRIALS PROFILE FOR ISOVUE-M 200

All Clinical Trials for ISOVUE-M 200

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.

Clinical Trial Conditions for ISOVUE-M 200

Condition Name

Condition Name for ISOVUE-M 200
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Pulmonary Embolism	1
Kidney Diseases	1

Condition MeSH

Condition MeSH for ISOVUE-M 200
Intervention	Trials
Renal Insufficiency	3
Kidney Diseases	3
Diabetes Mellitus	2
Coronary Artery Disease	2

Clinical Trial Locations for ISOVUE-M 200

Trials by Country

Trials by Country for ISOVUE-M 200
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for ISOVUE-M 200
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for ISOVUE-M 200

Clinical Trial Phase

Clinical Trial Phase for ISOVUE-M 200
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ISOVUE-M 200
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for ISOVUE-M 200

Sponsor Name

Sponsor Name for ISOVUE-M 200
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Duke University	2

Sponsor Type

Sponsor Type for ISOVUE-M 200
Sponsor	Trials
Industry	21
Other	9
NIH	1

ISOVUE-M 200 Market Analysis and Financial Projection

Last updated: May 2, 2026

ISOVUE-M 200: What the Clinical Pipeline and Market Outlook Indicate

What is ISOVUE-M 200 and where does it sit clinically?

ISOVUE-M 200 is an iodinated contrast media (ICM) product. It is marketed for intravascular and other imaging procedures in settings where iodinated x-ray contrast is required. As a legacy ICM, the commercial product line is largely shaped by regulatory status, labeling scope, procurement contracts, and supply stability rather than by new clinical efficacy trials typical of novel therapeutics.

Clinical-trial status

• No ongoing or newly reported Phase 3/Phase 2 efficacy programs are required to sustain a marketed ICM product line in the way new chemical entities do. For established contrast agents, updates generally take one of these forms:
  • label expansions (new indications, patient populations, or administration details),
  • manufacturing or formulation changes (with associated CMC submissions),
  • and postmarketing observational data rather than randomized efficacy programs.

What this means for a “clinical trials update”

• The actionable clinical information for ISOVUE-M 200 tends to be regulatory/label updates and safety surveillance rather than a steady stream of new interventional trials.
• When new studies appear, they usually aim at operational performance and safety characterization (e.g., comparative tolerability or administration workflow endpoints), not a re-establishment of fundamental diagnostic performance already demonstrated at product class level.

Is there any meaningful new clinical evidence driving the product’s market position?

For legacy ICM brands, the market impact of new evidence generally depends on whether it changes:

• payer coverage and utilization,
• hospital formulary placement,
• or risk-management protocols (e.g., renal impairment or allergy-prevention pathways).

Absent visible, publicly indexed interventional trial readouts tied specifically to ISOVUE-M 200, the clinical signal that typically moves demand is institutional protocol adoption and procurement pricing rather than a new clinical outcome trial.

Practical read-across for decision makers

• If your goal is near-term forecasting, the highest-yield “clinical” drivers for ISOVUE-M 200 are usually label language changes and safety communications, not new randomized trials.

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What is the market structure for iodinated contrast agents (ICMs) and how does ISOVUE-M 200 compete?

How does demand form in the ICM market?

ICM demand is procedure-driven. The dominant volume pools are:

• computed tomography (CT),
• angiography and vascular imaging,
• interventional radiology and cardiac imaging,
• and other radiographic imaging requiring iodinated contrast.

Hospital and imaging centers drive uptake via:

• formulary decisions (who supplies which agent),
• stocking and inventory management,
• imaging protocol standardization (dose selection, dilution rules, infusion vs bolus),
• and contract pricing.

What typically determines brand share in ICMs?

For established brands, the share engine is usually:

• price and contract terms (GPO alignment, annual replenishment agreements),
• supply reliability (lead times, batch consistency),
• device compatibility (bottle size, syringe compatibility, administration workflow),
• label fit for the institution’s patient mix,
• and switching friction (staff training, protocol validation, prior authorization rules if payers intervene).

ISOVUE-M 200 competes in this environment as one of the commercially available, commonly stocked iodinated contrast options, with performance judged heavily by nonclinical parameters (availability, logistics, and cost-per-procedure).

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What is the forecast logic for ISOVUE-M 200: growth, decline, or stability?

Base-case trajectory

Without a clearly identifiable, publicly reported “new evidence” engine specific to ISOVUE-M 200, the default forecast shape for legacy ICM brands is stable to modestly growing, tied to:

• growth in imaging volumes (CT utilization),
• mix shift toward higher frequency/high throughput sites,
• and contract-driven substitution across competing ICM brands.

Directional assumption that fits the product category

• Volume: modest growth with overall imaging demand.
• Unit economics: pressure from competition and contract pricing, especially in GPO-managed channels.
• Brand elasticity: moderate. Institutions will switch when pricing or supply favors an alternative.

Key scenario drivers

Market upside for ISOVUE-M 200:

• consistent allocation and supply continuity,
• favorable contract renewal terms,
• label refinements that reduce utilization barriers for common patient groups,
• and “protocol lock-in” at large hospital systems.

Downside:

• adverse procurement pricing,
• supply interruptions or shortages leading to temporary switching,
• and payer or institutional policy changes that steer use toward competing agents.

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Where do clinical and regulatory signals show up for ICM brands?

What counts as a material clinical update for ICMs

For an ICM like ISOVUE-M 200, the signals that move practice are typically:

• changes in boxed warnings or prominent sections of labeling,
• updated guidance for renal impairment risk management,
• and safety communications that affect prophylaxis or monitoring workflow.

Forecast impact channel

• If safety language tightens requirements, utilization can slow (or shift to alternatives).
• If language clarifies safe use pathways, adoption can improve.

How to treat “trial updates” for an ICM brand

In most cases, trial updates for ICM brands do not reset the market the way oncology or biologics do. Instead:

• randomized trial readouts are less likely to change routine clinical practice quickly,
• while safety updates and procurement terms change adoption faster.

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Market projection: what “numbers” can be projected from publicly observable signals

Projection framework (brand-level)

Because ISOVUE-M 200 is a legacy ICM product, a credible projection must rest on:

1. Imaging volume growth assumptions (procedure-driven demand for iodinated contrast).
2. Share stability/shift assumptions driven by contracting and substitution.
3. Price index assumptions capturing ongoing competitive pressure.

A full numeric forecast requires product-level sales, channel splits, and competitor pricing moves. Those are not provided here, so only a directional, decision-ready forecast framework can be stated based on standard ICM market mechanics.

Decision-ready directional projection

• Most likely outcome: stability to low-single-digit growth driven by imaging volume, with ongoing price pressure limiting revenue growth relative to procedure growth.
• Risk skew: moderate downside if supply, allocation, or contract pricing turns unfavorable.
• Upside constraint: without a distinct clinical adoption catalyst, upside is primarily contracting and logistics driven, not evidence-driven.

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What should investors and R&D leaders watch next for ISOVUE-M 200?

Commercial watchlist

• GPO and hospital contract renewals affecting ICM formulary placement.
• Any supply chain disruptions affecting lead times and allocation.
• Changes in labeling that affect administration protocols or renal/contrast risk mitigation.

Regulatory watchlist

• Label updates and safety communications that change contraindication language or monitoring recommendations.
• New warnings or boxed language updates that shift workflow requirements.

Clinical watchlist

• Postmarketing pharmacovigilance signals that lead to updated precautions.
• Any comparative clinical studies that directly influence procurement decisions, rather than general safety statements.

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Key Takeaways

• ISOVUE-M 200 is a legacy iodinated contrast media brand where market movement is driven primarily by procurement, supply reliability, and label-based workflow rules, not new randomized efficacy programs.
• A “clinical trials update” for this type of product typically shows up as label and safety surveillance rather than late-stage clinical readouts that restructure demand.
• Most likely market trajectory is stable to modest growth in volume with revenue growth constrained by pricing and substitution across competing ICMs.
• Near-term forecast sensitivity is highest to contract terms, formulary switches, and supply continuity, followed by label changes affecting safety workflow.

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FAQs

1. Is ISOVUE-M 200 still actively studied in new clinical trials?
   For legacy ICMs, publicly visible new interventional trials are typically not the main driver of market adoption; changes usually occur through label and safety updates rather than Phase 2/3 efficacy programs.

2. What most affects ISOVUE-M 200 utilization in hospitals?
   Procurement pricing and formulary placement, supply reliability, and protocol fit (administration workflow, monitoring requirements) are the dominant utilization drivers.

3. Do clinical safety findings for ICMs change demand quickly?
   They can, but the timing and magnitude depend on how labeling changes alter workflow requirements or contraindications for common patient groups.

4. How should market growth be modeled for an ICM brand?
   Use procedure-driven demand growth, combine it with brand share stability or substitution risk, and overlay contract-driven price pressure.

5. What are the main downside risks to a projection?
   Unfavorable contract renegotiations, supply disruptions that force switching, and label changes that tighten safety workflow requirements.

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References

[1] U.S. Food and Drug Administration. (n.d.). Drug approvals and labeling resources for iodinated contrast media (labeling and safety communications). FDA.
[2] American College of Radiology. (n.d.). Manual on Contrast Media (clinical guidance and safety considerations for iodinated contrast). ACR.
[3] PubMed. (n.d.). Search results for ISOVUE-M 200 and iodinated contrast media clinical studies (evidence and safety updates). NLM.