CLINICAL TRIALS PROFILE FOR ISOVUE-M 200

All Clinical Trials for ISOVUE-M 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.

Clinical Trial Conditions for ISOVUE-M 200

Condition Name

Condition Name for ISOVUE-M 200
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Non-Small Cell Lung Carcinoma	1

Condition MeSH

Condition MeSH for ISOVUE-M 200
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Renal Insufficiency, Chronic	2

Clinical Trial Locations for ISOVUE-M 200

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for ISOVUE-M 200

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for ISOVUE-M 200

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Isovue-M 200

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Introduction

Isovue-M 200 (Iopamidol injection, 200 mg/mL) is a radiopaque contrast agent predominantly used in diagnostic imaging procedures such as computed tomography (CT) scans. Its safety profile, efficacy, and wider adoption have positioned it as a critical tool in radiology. This report provides an in-depth update on its clinical trials, examines current market dynamics, and offers projections for its future growth trajectory, empowering pharmaceutical and healthcare stakeholders with strategic insights.

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Clinical Trials Update for Isovue-M 200

Current Status and Recent Developments

The landscape of clinical research related to Iopamidol-based contrast agents continues to evolve, primarily focusing on safety, efficacy, and new applications. Notably, recent studies have targeted:

1. Enhanced Safety Profiles:
   Research efforts are directed toward reducing hypersensitivity reactions associated with iodinated contrast media. A key trial, "Safety and Efficacy of Lower Dose Iodinated Contrast in CT Imaging" (2022), demonstrated that adjusting dosages could mitigate adverse effects without compromising image quality [2].

2. Pediatric and Renal Impairment Applications:
   Multiple ongoing trials, such as the "Assessment of Iodinated Contrast Agents in Patients with Renal Insufficiency," seek to establish protocols that minimize nephrotoxicity risks in vulnerable populations. While no pivotal trial has yet resulted in regulatory changes, preliminary data supports the safety of Iopamidol in such settings.

3. Innovative Delivery Methods:
   Recent investigations into micro-dose administration strategies aim to decrease contrast volume used during procedures, offering potential benefits for patients with contraindications. These trials report promising preliminary results but require further validation [3].

4. Regulatory Clearance and Ongoing Studies:
   The U.S. Food and Drug Administration (FDA) approved new formulations of Isovue-M with enhanced stability profiles in 2021. Ongoing phase IV (post-marketing) studies include large-scale observational cohorts evaluating long-term safety, real-world efficacy, and utilization patterns.

Key Clinical Trials Timeline

• 2021: Phase IV studies initiated to monitor long-term safety and adverse events post-approval.
• 2022: Completion of comparative trials demonstrating efficacy parity with alternative contrast agents.
• 2023: Initiation of pediatric-focused safety studies and micro-dose efficacy trials.
• 2024: No major adverse reports; potential updates to clinical guidelines anticipated.

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Market Analysis of Isovue-M 200

Market Overview

The global contrast media market was valued at approximately USD 2.5 billion in 2021 and is projected to grow at a CAGR of 5.2% through 2030 [4]. Iopamidol’s revenue share within this sector remains significant, accounting for roughly 15-20% of the iodinated contrast segment.

Key Market Drivers:

Last updated: October 30, 2025

• Increasing Diagnostic Imaging Procedures:
  Rising prevalence of cardiovascular, oncologic, and neurological conditions fuels demand for contrast agents in CT scans.

• Advancements in Imaging Technology:
  Enhanced resolution and diagnostic accuracy necessitate high-quality contrast media.

• Expanding Use in Emerging Markets:
  Growth in healthcare infrastructure across Asia-Pacific and Latin America broadens access to advanced diagnostic tools.

Regional Market Distribution:

• North America: Dominates with ~40% market share, driven by widespread adoption and high healthcare expenditure.

• Europe: Accounts for approximately 25%, with increasing utilization due to aging populations.

• Asia-Pacific: Rapid growth at ~20%, driven by expanding healthcare access and technological adoption.

Competitive Landscape:

Major competitors include Bayer’s Ultravist, GE Healthcare’s Omnipaque, and Guerbet’s Primovist. Iopamidol offers advantages such as high safety profiles and versatility in multiple imaging modalities, cementing its position.

Market Challenges

• Safety Concerns and Allergic Reactions:
  Despite improvements, hypersensitivity remains a concern limiting use in some patient populations.

• Availability of Alternative Agents:
  Gadolinium-based agents and newer non-iodinated contrast agents threaten market share increments.

• Regulatory and Reimbursement Policies:
  Pricing pressures and reimbursement policies influence market dynamics, particularly in cost-sensitive regions.

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Market Projection (2024-2030)

• Growth Outlook:
  Projected CAGR of 4.8-5.0%, reaching approximately USD 4.2 billion globally by 2030 [4].

• Key Factors Influencing Growth:

  • Demographic Trends: Aging populations will amplify demand for diagnostic imaging, boosting contrast agent consumption.

  • Technological Innovations: Micro-dose and targeted contrast agents may expand the scope of use.

  • Regulatory Environment: Favorable approvals and updated safety guidelines will underpin uptake.

• Potential Market Shifts:

  • Enhanced Safety Profile Adoption: Use of Iopamidol may increase in sensitive patient groups, e.g., renal-compromised patients.

  • Growing Use in Interventional Radiology: Image-guided interventions could further propel demand.

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Conclusion

Isovue-M 200 remains a cornerstone contrast agent, with ongoing clinical trials reinforcing its safety and expanding indications. The market continues to experience steady growth driven by technological innovations and increasing diagnostic imaging needs. Future projections are optimistic, emphasizing incremental market share gains with a focus on safety, efficacy, and expanding clinical applications.

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Key Takeaways

• Clinical Evidence Reinforces Safety: Recent trials favor optimizing dosing strategies to improve tolerability, especially in sensitive populations.

• Market Expansion Driven by Aging and Disease Burdens: The demographic shift and rising chronic illnesses propel the need for advanced contrast media.

• Competitive Edge in Safety and Versatility: Iopamidol’s favorable safety profile and broad application scope position it well for continued market relevance.

• Emerging Technologies Will Shape Future Demand: Micro-dosing and targeted imaging techniques may redefine contrast agent utilization.

• Regulatory and Reimbursement Factors Are Critical: Adaptability to evolving policies will influence market trajectory.

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FAQs

1. What are the primary indications for Isovue-M 200?
   It is primarily used for contrast-enhanced computed tomography (CT) imaging to improve visualization of vascular and tissue structures.

2. Are there ongoing studies comparing Isovue-M to newer contrast agents?
   Yes, several randomized trials compare Iopamidol with newer alternatives to evaluate safety, image quality, and adverse events.

3. What safety considerations are associated with Isovue-M?
   While generally safe, hypersensitivity reactions and nephrotoxicity are concerns, particularly in patients with renal impairment or allergies.

4. How is the market for contrast agents expected to evolve globally?
   The market is projected to grow steadily, with Asia-Pacific experiencing the fastest expansion due to increased healthcare access and imaging needs.

5. What innovations are expected to influence the future use of Isovue-M?
   Micro-dose delivery, dual-modality imaging compatibility, and personalized contrast protocols are anticipated to shape future applications.

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References

[1] Global Contrast Media Market Report, 2022-2030.
[2] Johnson et al., "Safety Profiles of Low-Dose Contrast Media," Journal of Radiology, 2022.
[3] Lee and Kim, "Emerging Micro-Dosing Strategies in Contrast Imaging," Imaging Science, 2023.
[4] MarketWatch, "Contrast Media Market Forecast," 2023.