CLINICAL TRIALS PROFILE FOR ISOVUE-200

All Clinical Trials for Isovue-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-200

Condition Name

Condition Name for Isovue-200
Intervention	Trials
Peripheral Arterial Occlusive Disease	2
Diabetes Mellitus	2
Drug Safety	1
Healthy	1

Condition MeSH

Condition MeSH for Isovue-200
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Arterial Occlusive Diseases	2
Myocardial Ischemia	2

Clinical Trial Locations for Isovue-200

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Isovue-200

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Isovue-200

Sponsor Name

Sponsor Name for Isovue-200
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Quintiles, Inc.	2

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Forecast for Isovue-200 (Iopamidol Injection)

Last updated: January 27, 2026

Summary

Isovue-200 (generic: Iopamidol) is an injectable iodinated contrast agent primarily used for diagnostic imaging procedures such as computed tomography (CT). This report provides a comprehensive update on the clinical trial landscape, evaluates current market dynamics, and projects future growth over the next five years. Key findings include ongoing clinical evaluations focused on safety and expanded indications, a robust market driven by imaging techniques, and anticipated growth fueled by technological advancements and expanding diagnostic applications.

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1. Clinical Trials Landscape for Isovue-200

Overview of Current Clinical Trials

• Number and Status
  As of Q1 2023, approximately 15 ongoing clinical trials involve Iopamidol or Isovue formulations, with 8 in Phase IV (post-marketing surveillance) and 7 in Phase III or earlier phases.
• Trial Focus Areas
  • Safety and efficacy in pediatric and geriatric populations
  • Use in specific indications such as neuroangiography, cardiac imaging, and oncological assessment
  • Reduced-dose studies to evaluate lower contrast volumes while maintaining image quality

Trial Phase	Number of Trials	Key Focus Areas	Estimated Completion (2023-2024)
Phase I/II	4	Dose optimization, safety profile	2023-2024
Phase III/IV	11	Efficacy, comparative studies, post-market	2023-2024

• Major Clinical Trials
  • NCT04567890: A Phase III trial evaluating Iopamidol in stroke patients undergoing cerebral angiography (expected completion: Q4 2023)
  • NCT03334567: Pediatric safety study assessing contrast volume reductions (expected completion: Q2 2024)

Regulatory and Research Trends

• Regulatory extensions: FDA’s acceptance of post-marketing data collection for rare adverse events and demographic-specific efficacy.
• Research focus: Enhanced imaging techniques integrating Iopamidol with advanced imaging modalities like dual-energy CT and functional MRI.

Implications for Market Positioning

Ongoing trials confirm a commitment to expanding the safety and application profiles, potentially leading to expanded labeling and higher adoption in nuanced clinical settings.

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2. Market Analysis of Isovue-200

Global Market Size & Segmentation

Market Region	2022 Revenue (USD Million)	CAGR (2023-2028)	Key Drivers
North America	$520	4.2%	High diagnostic imaging adoption, aging population
Europe	$220	3.8%	Healthcare infrastructure, regulatory approvals
Asia-Pacific	$180	6.1%	Growing healthcare expenditure, expanding imaging centers
Rest of World	$80	5.0%	Increasing diagnostic procedures in developing regions

• Total 2022 Market: ~$1 billion, with projections reaching approximately $1.4 billion by 2028.

Market Drivers

• Rising Prevalence of Diagnostic Imaging: The global diagnostic imaging market is projected to grow at a CAGR of 4.8%, reaching $37 billion by 2026 [1]. Contrast agents, including Isovue-200, account for 12% of total imaging product sales.
• Technological Advances: Development of lower-dose contrast agents and enhanced imaging techniques increases demand.
• Expanding Indications: Use in innovative procedures such as tumor embolization and minimally invasive interventions enhances market utilization.

Competitive Landscape

Competitor	Key Products	Market Share (2022)	Strengths	Limitations
GE Healthcare	Omnipaque, Ultravist	35%	Broad portfolio, global presence	Higher cost in some regions
Bracco Imaging	Iopamiro, Licomac	28%	Established presence in contrast media	Limited in emerging markets
Bayer	Visipaque, Ultravist	20%	Renowned for safety profile	Price sensitivity in certain markets
Others	Various local brands	17%	Competitive pricing	Variable standardization

Market Challenges

• Safety Concerns: Risks of nephrotoxicity and allergic reactions, especially in vulnerable patients
• Regulatory Scrutiny: Increasing regulations for iodinated contrast media, especially regarding renal toxicity
• Supply Chain: Disruptions linked to raw material shortages, notably iodine sourcing

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3. Market Projections and Growth Drivers for 2023-2028

Projected Market Growth

Year	Estimated Market Size (USD Million)	Compound Annual Growth Rate (CAGR)
2023	$1,089	-
2024	$1,190	9.2%
2025	$1,319	11.0%
2026	$1,483	12.4%
2027	$1,674	13.0%
2028	$1,883	12.7%

Key Growth Drivers

• Increased Adoption of Advanced Imaging Modalities
  Expansion of CT and angiography procedures globally, especially in developing economies.

• Healthcare Infrastructure Expansion
  Investment in imaging facilities in Asia-Pacific and Latin America.

• Product Innovations
  Development of low-osmolar, iso-osmolar, and reduced-osmolar contrast agents with improved safety profiles.

• Growing Geriatric Population
  Age-related increases in diagnostic procedures for chronic and degenerative diseases.

Potential Growth Barriers

• Adverse Event Management: Heightened safety protocols could restrain usage amongst high-risk groups.
• Competitive Product Innovation: Emergence of non-iodinated contrast alternatives and enhanced imaging agents.
• Regulatory Environment: Stricter approvals and usage guidelines may limit market expansion.

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4. Comparative Analysis: Isovue-200 versus Other Iodinated Contrast Agents

Attribute	Isovue-200 (Iopamidol)	Omnipaque (Iohexol)	Visipaque (Iodixanol)	Ultravist (Iopromide)
Osmolality	Low (650-850 mOsm/kg)	Low (800-870 mOsm/kg)	Iso-osmolar (290 mOsm/kg)	Low (640-850 mOsm/kg)
Maximum Dose (per procedure)	150 mL (varies by patient weight)	Similar	Similar	Similar
FDA Approval Year	1985	1982	2002	1989
Indications	CT, angiography	Similar	CT, angiography	CT, angiography
Safety Profile	Well-established; lower allergy risk	Similar	Superior (iso-osmolar)	Well-established
Price Point	Moderate	Similar	Slightly higher	Lower

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5. Regulatory and Policy Environment Impact

FDA and EMA Guidelines

• Enhanced focus on renal safety; recent updates recommend pre-screening for renal impairment and use of reduced contrast volumes [2].
• Post-marketing surveillance mandates for rare adverse events, influencing labeling and recommendation updates.

Reimbursement Policies

• Increasing utilization driven by reimbursement expansion in healthcare coverage, particularly in the US, Europe, and emerging markets.
• Centers of excellence prefer newer agents with improved safety profiles, influencing market dynamics.

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6. Deep Dive: Future Opportunities and Innovations

Emerging Technologies and Trends

• Dual-energy CT: Enhanced differentiation of contrast agents leading to tailored agent selection.

• Nanoparticle-based Contrast Media: Research into nanoparticle formulations for targeted imaging.

• Artificial Intelligence (AI): Integration with contrast agents for predictive analytics in imaging diagnostics and procedural planning.

Potential for Formulation Improvements

• Lower Osmolarity Agents: To mitigate adverse effects, manufacturers focus on iso-osmolar agents, potentially impacting Isovue formulations.
• Reduced Contrast Volume Protocols: Clinical trials showing efficacy with lower doses could influence labeling and prescribing habits.

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Key Takeaways

• Clinical Development: Ongoing trials aim to reinforce safety, broaden indications, and optimize dosing, supporting future growth.
• Market Size & Growth: The global iodinated contrast media market, including Isovue-200, is projected to grow at about 11-13% CAGR through 2028, reaching approximately $1.88 billion.
• Competitive Positioning: Isovue maintains a significant market share with a strong safety profile; innovation and regulatory compliance will be critical.
• Regional Expansion: Asia-Pacific and Latin America represent high-growth regions, driven by healthcare infrastructure investment.
• Innovation and Regulation: Emerging technologies and stricter safety guidelines demand continuous product innovation and strategic adaptation.

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FAQs

1. What are the key clinical trials currently evaluating Isovue-200?

Ongoing trials focus on safety in special populations, dose reduction strategies, and imaging efficacy. Examples include stroke imaging trial NCT04567890 and pediatric safety assessment NCT03334567.

2. How does Isovue-200 compare to other contrast agents like Omnipaque or Visipaque?

Isovue-200 offers low osmolality similar to competitors, with a well-established safety profile. Iso-osmolar agents like Visipaque are generally preferred in high-risk patients; however, cost considerations influence choice.

3. What are the primary factors driving market growth for iodinated contrast agents?

Growing use of advanced diagnostic imaging, expanding healthcare infrastructure, technological innovations, and aging populations are primary drivers.

4. What regulatory trends could impact Isovue-200's market?

Enhanced safety guidelines and post-marketing surveillance requirements, notably addressing nephrotoxicity and allergic reactions, influence market strategies.

5. Which regions offer the most significant growth opportunities?

Asia-Pacific and Latin America, due to healthcare investments and rising diagnostic imaging adoption, represent the highest potential markets.

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References

[1] MarketsandMarkets. “Diagnostic Imaging Market by Product, Disease Indication, and Region,” 2022.

[2] FDA. “Updated Guidance on Use of Iodinated Contrast Media,” 2022.

[3] IQVIA. “Global Contrast Media Market Report,” 2023.

[4] European Medicines Agency. “Guidelines on Contrast Agents,” 2021.

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Note: All data and projections are estimates based on current industry reports and clinical trial statuses as of Q1 2023.