CLINICAL TRIALS PROFILE FOR IOPAMIDOL-300

All Clinical Trials for Iopamidol-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 Iopamidol-300

Condition Name

Condition Name for Iopamidol-300
Intervention	Trials
Coronary Artery Stenosis	3
Coronary Artery Disease	2
Diabetes Mellitus	2
Contrast Agent With Lean Body Weight	1

Condition MeSH

Condition MeSH for Iopamidol-300
Intervention	Trials
Renal Insufficiency	6
Kidney Diseases	3
Coronary Stenosis	3
Coronary Disease	3

Clinical Trial Locations for Iopamidol-300

Trials by Country

Trials by Country for Iopamidol-300
Location	Trials
United States	21
Canada	2
Italy	2
China	2
Sweden	1

Trials by US State

Trials by US State for Iopamidol-300
Location	Trials
New Jersey	10
Minnesota	2
California	2
North Carolina	2
Illinois	2

Clinical Trial Progress for Iopamidol-300

Clinical Trial Phase

Clinical Trial Phase for Iopamidol-300
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Iopamidol-300
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for Iopamidol-300

Sponsor Name

Sponsor Name for Iopamidol-300
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for Iopamidol-300
Sponsor	Trials
Industry	27
Other	23
NIH	3

Iopamidol-300 Market Analysis and Financial Projection

Last updated: April 23, 2026

Iopamidol-300 Clinical Trials Update, Market Analysis, and Projection

What is Iopamidol-300 and what products matter commercially?

Iopamidol is a non-ionic, iodinated contrast medium used for intravascular and body imaging. “Iopamidol-300” denotes the 300 mgI/mL strength used in imaging settings where low osmolality and rapid tolerability matter. In-market commercialization is largely driven by:

• Hospital procurement of branded and private-label equivalents
• Tender-based pricing in large imaging networks
• Regulatory continuity of established manufacturing and pack configurations
• Substitution dynamics versus other iodinated, non-ionic agents (e.g., iohexol, iopromide, ioversol, iopamidol-370 where available)

Commercially, Iopamidol-300 is best treated as a mature, category-stable product rather than a high-innovation pipeline asset. The competitive battleground is availability, tenders, and price-to-performance, not new clinical endpoints.

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What does the clinical trials landscape show for Iopamidol-300?

There is no signal that Iopamidol-300 is undergoing a sustained wave of de novo, late-stage clinical development designed to change standard-of-care. For an older, generic-substitution-friendly contrast agent class, trial activity tends to cluster around:

• Formulation/manufacturing comparability
• Bioequivalence or bridging where regulatory pathways require it
• Imaging protocol studies (often small and protocol-specific rather than drug-differentiating)

Bottom line: Iopamidol-300 behaves like a mature regulated utility product. Clinical “updates” that influence market access typically come from regulatory actions (approvals, labeling updates, manufacturing changes), not from large Phase 3 outcomes.

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What clinical evidence base underpins Iopamidol-300 use?

Iopamidol is supported by long-standing clinical use across radiography, CT, and angiography workflows. The dominant evidence value for business planning is not new efficacy readouts but:

• Operational safety and tolerability profiles consistent with non-ionic, iodinated contrasts
• Predictable imaging performance used in protocols that specify iodine dose, flow rate, and injection parameters
• Clinical continuity that keeps switching costs low for procurement teams when supply and price are favorable

In commercial terms, this means tender wins drive volumes more reliably than incremental differentiation.

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What is the market structure for iodinated contrast and where does Iopamidol-300 sit?

The iodinated contrast market is dominated by non-ionic agents. Within that, Iopamidol competes at the intersection of:

• Strength portfolio (300 mgI/mL vs higher concentrations where clinically used)
• Injection kit and distribution compatibility with radiology departments
• Supply reliability and tender pricing

Key structural characteristics:

• Regulated product continuity: switching requires protocol alignment but is operationally feasible.
• Price competition: procurement often uses tender frameworks that compress margins.
• Class substitutability: if competing non-ionic agents remain in stock and are labeled for the same indication set, switching is routine.

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Who are the main competitive substitutes and how do they impact pricing?

The closest substitutes are other non-ionic, iodinated contrast media with comparable imaging utility. Competition pressure typically targets:

• Acquisition cost per imaging procedure
• Total cost of ownership (pack sizes, expiry management, supply assurance)
• Therapeutic equivalence in practice (workflow compatibility)

For Iopamidol-300, the market impact is a consistent pattern: pricing is capped by the availability and price of peer non-ionic agents, rather than by unique clinical superiority.

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What drives procurement and forecasting for Iopamidol-300?

Forecasting depends on volume rather than differentiation. The main drivers are:

• CT utilization trends and diagnostic imaging volumes (procedural growth)
• Radiology department mix (hospital vs ambulatory imaging centers)
• Tender cycles and regional contracting rules
• Manufacturing supply continuity and logistics reliability
• Regulatory and labeling continuity (pack changes, concentration availability)

Because the product is mature, forecast errors usually come from procurement and supply dynamics, not from clinical trial outcomes.

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How should market projection be built for a mature contrast agent like Iopamidol-300?

A practical projection model for Iopamidol-300 should be built on:

1. Imaging procedure volume growth (CT and related cross-sectional imaging)
2. Share-of-iodinated-non-ionic spend captured by Iopamidol-300
3. Tender-driven share shifts (scenario-based)
4. Retention and substitution rate relative to peer non-ionic agents
5. Pricing compression through generic or equivalent substitution

Given the absence of late-stage clinical differentiation, projections should reflect a mature product margin profile with stable demand and periodic share rotations.

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What is the near-term outlook for Iopamidol-300?

The near-term outlook is dominated by:

• Volume stability tied to diagnostic imaging demand
• Ongoing procurement price pressure
• Supply assurance as a competitive moat
• Regulatory continuity and manufacturing consistency

This translates into a market profile where:

• Growth is mostly demand-led
• Revenue is mostly tender-priced
• Competitive position is mostly procurement-relationship and supply reliability-led

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What scenarios matter most for business planning?

For a mature contrast medium, the actionable scenarios usually are:

• Base case: demand follows imaging procedure growth, share stable, pricing gradually compresses
• Upside case: improves tender win rates, supply advantage, or regional stocking leads to incremental share gains
• Downside case: competitive undercutting in tenders or supply interruptions shift share away

The clinical program is unlikely to be the primary driver of these outcomes.

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Key Takeaways

• Iopamidol-300 is a mature non-ionic iodinated contrast medium, and market performance is driven by procurement, tender cycles, pricing, and supply continuity, not new clinical differentiation.
• The clinical trials pipeline does not indicate a business-changing late-stage development wave; clinical “updates” are more likely to be regulatory and labeling/manufacturing continuity.
• Market projection should be procedure-volume-led with tender-based share and pricing compression baked in, using scenario inputs for competitive undercutting and supply events.

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FAQs

1. Is Iopamidol-300 growing due to new clinical approvals?
   Growth is expected to be demand and procurement driven, with approvals and labeling continuity typically providing the main regulatory updates rather than major clinical advances.

2. What most influences Iopamidol-300 revenue: volume or price?
   For mature contrast agents, both matter, but tender pricing and substitution frequently dominate revenue per unit.

3. What determines whether hospitals switch Iopamidol-300?
   Switching is usually controlled by tender terms, drug availability, pack compatibility, and protocol alignment, given class substitutability.

4. Does the concentration (300 mgI/mL) change competitive dynamics?
   Yes, concentration affects protocol iodine dose calculations and kit usage, but the competitive set remains other non-ionic iodinated agents.

5. Are clinical trials a reliable indicator of near-term market share for Iopamidol-300?
   For mature contrast products, clinical trial news rarely drives immediate share; operational factors in procurement and supply do.

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References

[1] Food and Drug Administration. Drug Approval Reports and Labels for iodinated contrast media (database and labeling archives). U.S. FDA. (Accessed 2026-04-23).
[2] European Medicines Agency. Public assessment reports and product information for iodinated contrast media (EMA). European Medicines Agency. (Accessed 2026-04-23).
[3] World Health Organization. Use and safety information for contrast media in diagnostic imaging (guidance and documents). World Health Organization. (Accessed 2026-04-23).
[4] ClinicalTrials.gov. Search results for iopamidol trials and related comparability or protocol studies. U.S. National Library of Medicine. (Accessed 2026-04-23).