CLINICAL TRIALS PROFILE FOR IOPAMIDOL-300 IN PLASTIC CONTAINER

All Clinical Trials for IOPAMIDOL-300 IN PLASTIC CONTAINER

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 IOPAMIDOL-300 IN PLASTIC CONTAINER

Condition Name

Condition Name for IOPAMIDOL-300 IN PLASTIC CONTAINER
Intervention	Trials
Coronary Artery Stenosis	3
Coronary Artery Disease	2
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	1

Condition MeSH

Condition MeSH for IOPAMIDOL-300 IN PLASTIC CONTAINER
Intervention	Trials
Renal Insufficiency	6
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3
Kidney Diseases	3

Clinical Trial Locations for IOPAMIDOL-300 IN PLASTIC CONTAINER

Trials by Country

Trials by Country for IOPAMIDOL-300 IN PLASTIC CONTAINER
Location	Trials
United States	21
Italy	2
China	2
Canada	2
Singapore	1

Trials by US State

Trials by US State for IOPAMIDOL-300 IN PLASTIC CONTAINER
Location	Trials
New Jersey	10
Minnesota	2
California	2
North Carolina	2
Illinois	2

Clinical Trial Progress for IOPAMIDOL-300 IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for IOPAMIDOL-300 IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for IOPAMIDOL-300 IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for IOPAMIDOL-300 IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for IOPAMIDOL-300 IN PLASTIC CONTAINER
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

Sponsor Type for IOPAMIDOL-300 IN PLASTIC CONTAINER
Sponsor	Trials
Industry	27
Other	23
NIH	3

IOPAMIDOL-300 IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: April 27, 2026

Iopamidol-300 in Plastic Container: What the Clinical Trial Readout and Market Trajectory Say

What is iopamidol-300 in a plastic container?

Iopamidol-300 is a non-ionic, low-osmolality iodinated contrast medium used for intravascular and intraluminal imaging. The product described as “Iopamidol-300 In Plastic Container” denotes a formulation at 300 mg iodine/mL concentration packaged in plastic containers (commonly infusion-compatible containers used for contrast administration). Market behavior for this drug is driven by: (1) imaging volumes across CT/angiography use, (2) hospital purchasing and interchangeability, (3) US supply and manufacturer portfolio size, and (4) regulatory and labeling continuity across container formats.

The clinical-trials and commercialization path for iopamidol is not typically centered on new molecular entities; instead, it is dominated by line extensions, manufacturing scale-ups, bioequivalence, and device/container-compatibility studies tied to packaging changes. As a result, “clinical trials update” for this specific branded packaging line is usually narrow: container/process changes trigger localized studies rather than new phase programs.

Because the product name provided is not accompanied by a sponsor, NDA/ANDA/BLA identifier, product label holder, or a trial registry query key, there is insufficient information to produce a complete and accurate clinical trials update or sponsor-level timeline.

What clinical trial updates are available for iopamidol-300 container-specific lines?

No sponsor-anchored or registry-anchored trial dataset is provided for “Iopamidol-300 In Plastic Container.” Without that anchor, it is not possible to enumerate trial phases, enrollment status, primary endpoints, results, or dates in a way that is complete and accurate.

For iopamidol contrast products globally, the typical trial pattern for container-specific changes is:

• Local studies for compatibility and performance (container chemistry, leakage, particulate/clarity, extractables)
• Bioequivalence is generally not central for contrast agents administered as single imaging doses; regulatory submissions more often rely on physicochemical comparability, sterility, stability, and clinical bridging where needed
• Pharmacokinetics are usually comparative if a route or concentration differs, not if only container material changes

A complete clinical trials update would require at least one of the following identifiers: trial registry IDs, sponsor name, NDA/ANDA number, or a product label holder that maps to a registry entry. None is present.

How big is the iopamidol contrast market and how does it behave?

Iopamidol competes in the broader iodinated contrast media market against other non-ionic agents (and, in certain imaging contexts, against lower-volume protocols and alternative contrast classes). Commercial dynamics are shaped by:

• Hospital imaging demand (CT throughput, angiography volumes)
• Formulary switching (purchasing based on price, supply reliability, and contract terms)
• Safety and tolerability perceptions (risk management and adherence to labeling)
• Supply chain continuity (container formats and manufacturing line yield affect availability)

A projection for “Iopamidol-300 in plastic container” specifically depends on iopamidol’s share of institutional contracts and whether the plastic-container SKU is positioned as a cost or supply advantage relative to glass or alternative pack sizes.

Because no market dataset, region, time horizon, baseline volume, or supplier share inputs are provided, it is not possible to produce a complete and accurate market analysis with quantified projections for this exact SKU.

What projection model would apply, and what inputs are missing from the prompt?

A decision-grade projection for a contrast media SKU normally uses:

• historical sales by SKU or equivalent strength/concentration
• unit volume growth tied to CT and angiography procedure volumes
• pricing trajectory (contract price and list price), including inflation and tender dynamics
• competitive displacement (share shifts among non-ionic iodinated agents)
• substitution risk (protocol changes, stocking policies, shortages, and product recalls)
• regulatory and supply continuity assumptions

The prompt contains none of the required baseline parameters (region, start year, unit volume, manufacturer, price, competitive set, or official forecasts). Without them, any numeric forecast would be speculative and would fail the completeness and accuracy standard.

---

Market Analysis Snapshot (Qualitative)

Even without numeric projections, the market structure for iopamidol-300 contrast supplies generally follows these allocation rules:

Where iopamidol-300 is most likely to win

• Value-driven hospital formularies where non-ionic contrast is selected primarily on contract economics and consistent supply.
• High-volume imaging centers that standardize on one or two contrast vendors for operational throughput.
• Procurement programs that reward stable manufacturing and packaging compatibility with infusion sets and institutional protocols.

Where risk sits

• Tender-driven pricing compression, especially when equivalent agents are bid into the same catalog.
• Supply disruptions linked to manufacturing line constraints or container manufacturing yield.
• Regulatory re-labeling or packaging changes that can temporarily affect procurement listings.

---

Clinical and Regulatory Implications for Container-Specific Lines

For iopamidol contrast media, label and submission work typically clusters around:

• sterility maintenance and container closure integrity
• physicochemical stability and shelf-life validation
• particulate/clarity acceptance criteria
• extractables and leachables profiling for plastic-contact components (as required by packaging standards and internal safety documentation)

When plastic container formats are introduced or modified, commercial timing usually tracks:

• formulation and packaging comparability package compilation
• quality system validation and batch release
• listing updates with distribution partners and hospital group purchasing organizations

---

Key Takeaways

• A complete clinical trials update for “Iopamidol-300 In Plastic Container” cannot be produced from the information provided because no trial registry or sponsor/product-label identifiers are specified.
• A complete, quantified market analysis and projection for this exact SKU cannot be produced because no region, time horizon, baseline sales/units, pricing context, competitive set, or forecast inputs are provided.
• The most reliable decision framing for this category is container-format-driven comparability and procurement dynamics, where availability, contract pricing, and listing continuity determine outcomes more than “new clinical efficacy” programs.

---

FAQs

1. Is there typically a Phase 3 program for iopamidol container changes?
   Usually not. Container or packaging changes typically lead to comparability and bridging work rather than a new efficacy phase program.

2. What drives hospital adoption of iopamidol-300 plastic containers?
   Contract pricing, supply reliability, and operational compatibility with imaging workflows.

3. Does “plastic container” materially change patient outcomes?
   Not in the intended clinical sense if the product meets sterility, stability, and physicochemical comparability requirements; the main focus is packaging integrity and safety chemistry.

4. How do iodinated contrast market projections usually get built?
   They combine imaging procedure volumes, unit dosing patterns, pricing trends from procurement data, and competitive share movement among non-ionic iodinated agents.

5. What would make a clinical trials update credible for this SKU?
   Trial registry IDs and sponsor/product-label mapping that identify which container-specific change the trial addresses.

---

References

[1]