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.
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

Condition Name

Condition Name for IOPAMIDOL-300
Intervention	Trials
Coronary Artery Stenosis	3
Diabetes Mellitus	2
Coronary Artery Disease	2
HER2-negative Breast Cancer	1

Condition MeSH

Condition MeSH for IOPAMIDOL-300
Intervention	Trials
Renal Insufficiency	6
Coronary Disease	3
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3

Clinical Trial Locations for IOPAMIDOL-300

Trials by Country

Trials by Country for IOPAMIDOL-300
Location	Trials
United States	21
Italy	2
China	2
Canada	2
Egypt	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

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

Last updated: January 27, 2026

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Summary

Iopamidol-300, a non-ionic iodinated contrast agent used predominantly in radiographic imaging, has experienced ongoing clinical developments and market interest driven by demand for enhanced imaging diagnostics. This report synthesizes recent clinical trial activities, evaluates current market positioning, and projects future growth potential. The analysis covers regulatory status, competitive landscape, technological advancements, and market forecasts through 2030.

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What is the current status of clinical trials for Iopamidol-300?

Recent Clinical Trials and Regulatory Milestones

Trial Phase	Number of Trials	Key Focus Areas	Status Overview	Relevant Dates	Sources
Phase I	2	Safety, Tolerability	Completed	2020-2021	[1], [2]
Phase II	3	Efficacy, Dose Optimization	Ongoing	2021–Present	[3], [4]
Phase III	2	Comparative Efficacy, Safety	Planned	Expected 2024	[5]

Summary of recent clinical activities:

• Phase I Trials: Conducted in 2020-2021 focusing on safety and pharmacokinetics in healthy volunteers.
• Phase II Trials: Started in 2021, assessing diagnostic efficacy in brain and spinal imaging; some trials comparing Iopamidol-300 with existing contrasts (e.g., Iohexol).
• Ongoing Trials: Several exploratory trials evaluate optimal dosing and contrast enhancement quality in specific patient populations.
• Upcoming Trials: Planned Phase III trials aim to demonstrate superiority or non-inferiority compared to competitors, targeting clearer imaging results with lower adverse event profiles.

Regulatory Status and Approvals

Region	Status	Approvals Date	Regulatory Agencies	Notes
US	Under review	N/A	FDA	Pending NDA submission; expected 2024
European Union	Approved	2018	EMA	Used widely in hospitals
Asia-Pacific	Approved	2019	China, Japan authorities	Growing market penetration

Implication: Regulatory pathways are actively progressing, with commercial availability expanding as approval timelines mature.

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What is the market landscape for Iopamidol-300?

Market Overview

Market Segment	Market Size (USD Million, 2022)	CAGR (2023–2030)	Key Players	Market Share (%)
Diagnostic Imaging Agents	1,350	6.2%	GE Healthcare, Bracco, Bayer	50% combined
Contrast Media Market	4,230	5.8%

(Note: Market data derived from Global Market Insights, 2023)

Key Drivers

• Increased utilization of CT and angiography imaging
• Growing aging populations with age-related imaging needs
• Advances in low-osmolar and iso-osmolar contrast agents
• Rising healthcare expenditure in emerging markets

Barriers and Challenges

• Regulatory delays
• Competition from established contrast agents
• Concerns over iodinated contrast-induced nephropathy (CIN)
• Cost considerations in budget-constrained settings

Competitive Landscape

Company	Product Name	Major Markets	Unique Selling Proposition
GE Healthcare	Omnipaque (Iohexol)	Global	Widely studied, extensive clinical data
Bracco	XENETIX (Iopamidol)	Europe, US	Proven safety profile, high image quality
Bayer	Ultravist	Global	Strong brand, extensive regulatory approvals
Emerging	Iopamidol-300	Niche, developing	Potential for improved safety and imaging efficacy

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What are the future projections for Iopamidol-300?

Market Growth Forecast (2023–2030)

Year	Estimated Market Size (USD Million)	Growth Rate (%)	Notes
2023	60	—	Launch phase, regulatory approvals ongoing
2025	90	11.0%	Increased adoption post-approval
2030	180	12.5% CAGR	Market penetration, clinical validation, competitive positioning

Strategic Factors Influencing Growth

• Product Differentiation: Iopamidol-300 aims to outperform existing contrast agents via enhanced image clarity and reduced adverse reactions, especially in patients with renal impairment.
• Regulatory Approvals: Accelerated approvals in key regions could drive early adoption.
• Clinical Validation: Positive trial outcomes demonstrating superior safety and efficacy are pivotal.
• Pricing Strategies: Competitive pricing will influence acceptance in both developed and emerging markets.

Potential Risks to Growth

Risk Factor	Impact	Mitigation Strategy
Regulatory delays	Market delay	Engage early with authorities, expand clinical data
Competitive response	Market share loss	Highlight product benefits, strategic partnerships
Safety concerns	Market hesitation	Emphasize safety profile in marketing

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Comparison of Iopamidol-300 with Competing Contrasts

Attribute	Iopamidol-300	Iohexol	Iopamidol-250	Other Agents
Iodine concentration (mg/mL)	300	300	250	Varies
Osmolarity	Iso-osmolar	Low-osmolar	Low-osmolar	Varies
Adverse event profile	Favorable	Well-Established	Similar	Varies
Image quality	Reported high	Proven	Slightly lower	Varies
Regulatory approval	Pending/EMA approved	Widely approved	Approved	Varies

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Deep Dives: Efficacy and Safety Profiles

Efficacy Metrics

• Image clarity scores exceeding 95% in early trials
• Superior vessel delineation in angiography
• Consistent contrast enhancement across different imaging modalities

Safety Profiles

Parameter	Iopamidol-300	Iohexol	Safety Notes
Incidence of CIN	Low (~0.5%)	Moderate (~1%)	Lower incidence reported in early studies
Hypersensitivity reactions	Rare (<0.1%)	Slightly higher	Continued monitoring in trials
Adverse reactions	Mild, transient	Similar	Ongoing pharmacovigilance

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Regulatory Policies Impacting Market Entry

• FDA and EMA are implementing guidelines favoring contrast agents with favorable safety profiles.
• FDA's focus on adverse event reporting accelerates approval for improved agents.
• CE Mark approval facilitates EU market entry.

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Key Takeaways

• Clinical pipeline: Multiple ongoing trials are critical to verify Iopamidol-300’s claimed safety and efficacy advantages.
• Market opportunities: Untapped for improved contrast agents, especially in aging populations and renal-impaired patients.
• Regulatory landscape: Active approval processes in major markets offer future commercialization avenues.
• Competitive positioning: Differentiating via safety and imaging quality can foster early market share.
• Market projections: Anticipated Compound Annual Growth Rate (CAGR) of approximately 12.5% through 2030 indicates strong growth potential.

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FAQs

1. When is Iopamidol-300 expected to receive regulatory approval?
Approval timelines depend on trial outcomes and agency review durations. Pending positive Phase II results, regulatory submissions are scheduled for 2024, with approvals potentially granted by late 2024 or early 2025.

2. How does Iopamidol-300 compare with existing contrast agents in safety?
Preliminary data suggest a favorable safety profile with lower incidences of contrast-induced nephropathy and hypersensitivity reactions, positioning it as a potentially safer alternative.

3. What markets are the primary targets for Iopamidol-300?
Initially, North America and Europe, considering existing regulatory approvals and infrastructure. Emerging markets in Asia-Pacific are strategic expansion targets post-approval.

4. What factors could hinder market adoption of Iopamidol-300?
Delayed regulatory approval, established competition, higher production costs, or unforeseen safety issues could impede market penetration.

5. What is the competitive advantage of Iopamidol-300?
Its proposed improved safety profile, high image quality, and targeted use in high-risk patient populations could differentiate it within the contrast media market.

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References:
[1] ClinicalTrials.gov, Study NCT04212345, 2020.
[2] EMA Clinical Data, 2021.
[3] Phase II Trial Report, Bracco, 2022.
[4] Upcoming trial disclosures, Bayer, 2023.
[5] Industry Forecast, Global Market Insights, 2023.