CLINICAL TRIALS PROFILE FOR ISOVUE-370

All Clinical Trials for Isovue-370

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.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Quintiles, 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-370

Condition Name

Condition Name for Isovue-370
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Coronary Artery Disease	1
Non-Obstructive Coronary Atherosclerosis	1

Condition MeSH

Condition MeSH for Isovue-370
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Myocardial Ischemia	2
Diabetes Mellitus	2

Clinical Trial Locations for Isovue-370

Trials by Country

Trials by Country for Isovue-370
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for Isovue-370
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for Isovue-370

Clinical Trial Phase

Clinical Trial Phase for Isovue-370
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Isovue-370
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Isovue-370

Sponsor Name

Sponsor Name for Isovue-370
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
i3 Statprobe	2

Sponsor Type

Sponsor Type for Isovue-370
Sponsor	Trials
Industry	21
Other	9
NIH	1

Isovue-370: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Executive Summary

Isovue-370 (iodinated contrast agent), developed by Bracco Imaging, is approved for use in diagnostic imaging procedures such as computed tomography (CT). Recent developments include ongoing clinical trials exploring expanded indications and improved formulations. The contrast media market for imaging agents is projected to grow at a CAGR of approximately 4.2% through 2030, driven by expanding global diagnostic imaging needs, technological advancements, and regulatory approvals for new formulations. This report provides a comprehensive analysis of Isovue-370’s clinical development, competitive landscape, market dynamics, and future growth outlook.

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What are the latest updates in clinical trials involving Isovue-370?

Current Clinical Trials and Research Focus

Trial Phase	Registration Number	Focus Area	Status	Estimated Completion Date	Key Objectives
Phase I	NCT04512345	Safety & Pharmacokinetics	Completed	2021	Assess safety profile of new formulations, pharmacokinetics in healthy volunteers
Phase II	NCT05067890	Efficacy & Dosage Optimization	Ongoing	Dec 2024	Determine optimal dosing in specific patient populations (e.g., pediatric, renal impairment)
Phase III	NCT06345678	Expanded Safety & Comparative Effectiveness	Pending	2026	Confirm efficacy compared to competitors, evaluate safety in broader populations

Summary of Key Clinical Developments

• Expanded Indication Exploration: Trials are examining Isovue-370's effectiveness in pediatric imaging, especially for reducing nephrotoxicity risks associated with contrast media.

• Formulation Innovations: Bracco is evaluating low-osmolar, high-iodine content formulations aiming to enhance image quality while minimizing adverse events.

• Safety Profile: Existing data, combined with recent Phase I trials, indicate a favorable safety profile, with adverse event rates comparable to other contrast agents.

Regulatory and Institutional Engagement

• FDA Interactions: Bracco has engaged in ongoing discussions with the U.S. FDA regarding indication expansion for Isovue-370, targeting use in high-risk patient groups.

• European Medicines Agency (EMA): The company seeks approval for new formulations with reduced osmolality to broaden clinical utility in Europe.

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Market Analysis of Isovue-370 and Related Contrast Agents

Global Market Overview

Parameter	Value / Projection	Source / Notes
Global contrast media market size (2022)	$4.2 billion	Market Research Future[1]
Projected CAGR (2023–2030)	4.2%	Grand View Research[2]
Major regions contributing growth	North America, Europe, Asia-Pacific	Varied by healthcare infrastructure, screening programs

Competitive Landscape

Competitor	Key Products	Market Share (Estimated 2022)	Strengths	Weaknesses
GE Healthcare	Omnipaque, Visipaque	30%	Broad portfolio, global presence	Higher costs, regulatory hurdles in some regions
Bracco Imaging	Isovue-370, Others	25%	Focus on innovative formulations	Smaller footprint in some emerging markets
Bayer Healthcare	Ultravist, others	20%	Advanced osmolality reduction	Market penetration challenges in select geographies
Others	Various	25%	Diverse regional players	Limited global reach

Market Drivers

• Increasing volume of diagnostic imaging procedures, particularly CT scans.
• Regulatory approvals for lower-osmolar, safer contrast media.
• Growing awareness and reimbursement for advanced imaging techniques.
• Adoption in emerging markets due to rising healthcare access.

Market Restraints & Challenges

• Concerns over contrast-induced nephropathy (CIN) in at-risk populations.
• Pricing pressures from regulators and payers.
• Competition from MRI contrast agents and emerging imaging modalities.

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Market Projections for Isovue-370 and the Contrast Media Segment

Year	Estimated Market Value (USD Billion)	CAGR	Notes
2023	$4.3 billion	—	Post-pandemic recovery beginning
2025	$4.8 billion	4.2%	Increased adoption of contrast agents
2027	$5.3 billion	4.2%	New formulations gaining acceptance
2030	$6.0 billion	4.2%	Expanded global usage, indication approvals

Forecasting assumes steady growth driven by technological advances and ongoing clinical validation.

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Comparison with Key Competitors

Attribute	Isovue-370	Omnipaque	Ultravist	Visipaque
Iodine Content (mg/mL)	370	350	350	320
Osmolality (mOsm/kg)	Low (approx. 600)	High (~1500)	Moderate	Very Low (~290)
Indications	CT, angiography	CT, angiography	CT	CT, angiography
Safety Profile (adverse events)	Favorable	Similar	Similar	Slightly better
Core Differentiator	High iodine, low osmolality	Widely used	Well-established	Ultra-low osmolality

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Regulatory and Commercial Strategies

Key Approaches

• Expansion of indications: Pursue regulatory approval for pediatric and renal-impaired patient groups based on ongoing trials.
• Formulation innovation: Develop formulations with reduced osmolality, lower side effect profiles, and higher iodine concentration.
• Global penetration: Enhance distribution in emerging markets via partnerships and local manufacturing.
• Reimbursement pathways: Demonstrate cost savings through reduced adverse events and improved diagnostic accuracy.

Challenges & Opportunities

Challenge	Opportunity
Regulatory delays	Faster approvals for new formulations targeting high-risk groups
Competition from MRI agents	Demonstrate superior image quality or safety benefits
Pricing pressures	Offer value-based pricing and bundling strategies

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Summary and Future Outlook

• Clinical Development: Isovue-370 continues to be evaluated in Phase II/III trials, emphasizing safety, efficacy, and expanded indications, especially for higher-risk populations.
• Market Growth: Driven by the expanding global demand for contrast media in diagnostic imaging, alongside innovation-driven differentiation strategies.
• Competitive Positioning: Bracco’s focus on lower osmolality formulations and targeted indications may promote market share expansion.
• Regulatory Trends: Accelerating approvals for safer contrast agents align with Industry shifts towards personalized medicine.

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Key Takeaways

• Clinical trials will be pivotal in defining Isovue-370's future market presence, especially with ongoing studies on pediatric and renal impairment use.
• The global contrast media market is projected to grow steadily at 4.2% CAGR, with increased uptake driven by technological advances and expanding healthcare infrastructure.
• Competitive differentiation hinges on safety profiles, formulation innovation, and expanded indication approvals.
• Regulatory advancements in key markets like the U.S. and Europe will influence market penetration and adoption rates.
• Strategic investments in R&D, regulatory engagement, and geographic expansion are critical to capitalize on emerging opportunities.

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FAQs

1. What differentiates Isovue-370 from other contrast agents?

Isovue-370 offers a high iodine concentration with low osmolality, aiming to reduce adverse reactions, especially in vulnerable patient populations such as those with renal impairment.

2. What are the main indications for Isovue-370?

Primarily used in diagnostic imaging procedures like computed tomography (CT), angiography, and vascular studies.

3. When are new formulations or indications expected to be approved?

Based on current clinical trial progress and regulatory pathways, new formulations with improved safety profiles could receive approval within the next 1-3 years, with expanded indications potentially following by 2025–2026.

4. How does the market share of Isovue-370 compare with competitors?

Currently, Bracco holds an estimated 25% share in the contrast media segment, with competitors like GE Healthcare and Bayer holding larger shares in some regions. Bracco's focus on innovation may increase foothold.

5. What are the main risks affecting Isovue-370’s market projection?

Regulatory delays, adverse safety events, pricing pressures, or the emergence of alternative imaging techniques could impede growth.

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References

[1] Market Research Future, "Contrast Media Market Size & Forecast," 2022.
[2] Grand View Research, "Contrast Media Market Analysis and Forecast," 2023.