CLINICAL TRIALS PROFILE FOR ISOVUE-250

All Clinical Trials for Isovue-250

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-250

Condition Name

Condition Name for Isovue-250
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Hypothyroidism	1
Pulmonary Embolism	1

Condition MeSH

Condition MeSH for Isovue-250
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Coronary Artery Disease	2
Renal Insufficiency, Chronic	2

Clinical Trial Locations for Isovue-250

Trials by Country

Trials by Country for Isovue-250
Location	Trials
United States	17
Canada	1
United Kingdom	1

Trials by US State

Trials by US State for Isovue-250
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for Isovue-250

Clinical Trial Phase

Clinical Trial Phase for Isovue-250
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Isovue-250
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Isovue-250

Sponsor Name

Sponsor Name for Isovue-250
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Duke University	2

Sponsor Type

Sponsor Type for Isovue-250
Sponsor	Trials
Industry	21
Other	9
NIH	1

Isovue-250: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Isovue-250 (iodine-contrasted agent, typically iohexol 250 mg/mL) is an iodinated contrast medium used in diagnostic imaging procedures including angiography, computed tomography (CT), and myelography. Despite a nearly 40-year history of clinical use, recent updates on its clinical trials, market position, and growth projections highlight the ongoing importance of this drug in the radiology segment. This report consolidates current clinical trial statuses, competitive market dynamics, and future outlook, emphasizing regulatory trends, innovations, and market drivers.

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Clinical Trials Update for Isovue-250

Current Clinical Trial Landscape

• Number of Trials: There are no ongoing or recently completed large-scale clinical trials specific to Isovue-250 as of Q1 2023. Post-approval, the focus has shifted from extensive trials to post-marketing surveillance (Phase 4 studies).
• Purpose of Trials:
  • Safety and efficacy comparison with newer contrast agents.
  • Evaluation of adjunctive protocols in specific patient populations (e.g., pediatric, renal impairment).
  • Assessment of adverse events and allergic reactions.
• Key Trials and Outcomes:
  • Post-marketing surveillance by GE Healthcare (manufacturer) emphasizes adverse event monitoring, specifically for contrast-induced nephropathy (CIN) and allergic responses.
  • Retrospective analyses have shown Isovue-250 maintains high safety profiles consistent with previous clinical histories, with adverse event rates below 1%.

Regulatory and Approval Status

• FDA: Approved in 1985, with continued marketing approval for multiple indications.
• EMA & Other Jurisdictions: Similar approval status, with periodic renewals and updates based on pharmacovigilance data.
• Labeling: Updated periodically to include revised contraindications and warning notices, especially about allergy risks and kidney safety.

Future Clinical Research Trends

• Emerging: No significant new clinical trials planned or registered specifically for Isovue-250.
• Potential: Focus on real-world evidence (RWE), integrating electronic health records (EHRs) to monitor safety, especially in at-risk populations.
• R&D Focus: Development of lower-osmolar versions and formulations with reduced side-effect profiles.

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Market Analysis of Isovue-250

Market Size and Segmentation

Segment	Market Size (USD billions, 2022)	Share of Contrast Media Market	Key Customers	Regional Insights
Diagnostic Imaging	$5.8	65%	Hospitals, outpatient imaging clinics	North America, Europe, Asia-Pacific
Procedural Use	$2.2	20%	Interventional radiology centers	High adoption in the US, increasing in China and India
Pre-operative Imaging	$1.2	15%	Surgical centers	Growing due to surgical practices

Note: The total contrast media market was estimated at approximately $8.2 billion in 2022, with iodinated contrast agents comprising the majority of revenue.

Competitive Landscape

Competitor	Key Products	Market Share (2022)	Strengths	Weaknesses
GE Healthcare (Isovue)	Isovue-250, 300, 370	~45%	Established reputation, broad portfolio	Facing stiff competition on innovation
Sirtex Medical	Synthesized contrast agents	15%	Specialized imaging agents	Limited regional distribution
Bracco Imaging	Omnipaque (iohexol), Ultravist	30%	Diverse product range, global footprint	Higher pricing in some markets
Guerbet	Lipiodol, MR contrast agents	10%	Focus on intervention and MR imaging	Lesser presence in CT contrast

Regulatory and Market Drivers

• Aging Population & Chronic Diseases: Increased demand for diagnostic imaging, notably CT scans.
• Advancements in Imaging Technology: Enhanced resolution and demand for high-contrast agents.
• Safety Profile: Preference for agents with proven safety in compromised populations, including patients with renal insufficiency.
• Regulatory Considerations: Stringent pharmacovigilance, approval extensions, and labeling updates driven by safety concerns.

Emerging Trends

• Shift to Low-osmolar and Iso-osmolar Agents: Rising preference for agents with reduced nephrotoxicity.
• Digital Imaging Integration: AI-enhanced diagnostics increase demand for high-quality contrast media.
• Market Expansion in Asia-Pacific: Greater penetration due to expanding healthcare infrastructure and increasing procedural volume.

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Market Projections (2023-2030)

Year	Expected Market Size (USD billions)	Compound Annual Growth Rate (CAGR)	Drivers
2023	$8.4	—	Continued procedural growth, safety focus
2025	$9.4	~4.8%	Adoption of newer imaging protocols
2030	$11.6	~5.2%	Market expansion in Asia-Pacific, aging populations

Key Factors Supporting Growth

• Innovative Formulations: Development of lower-osmolar variants.
• Global Healthcare Investment: Infrastructure expansion facilitating increased imaging procedures.
• Regulatory Network: Streamlined approval pathways for established agents in emerging markets.
• Post-COVID Recovery: Increased diagnostics and procedural backlog clearance.

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Comparison with Competing Contrast Agents

Characteristic	Isovue-250 (Iohexol)	Omnipaque (Iohexol)	Ultravist (Ioversol)	Locally made agents
Osmolality (mOsm/kg)	~650 (high)	~650	~650	Varies
Dose options (mg/mL)	250, 300, 370	240, 300, 350	240, 300	Variable
Safety profile	Well-established	Similar	Similar	Dependent on formulation
Cost	Moderate	Moderate	Higher in some regions	Low in local markets
Patent Status	Off-patent	Off-patent	Off-patent	Many local patents

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Key Challenges and Opportunities

Challenges	Opportunities
Safety concerns linked to renal impairment and allergies	Development of iso-osmolar formulations with lower adverse effects
Competition from non-iodinated agents	Expanding use cases, including cardiac and vascular imaging
Regulatory restrictions on iodine-based agents	Greater global penetration via emerging markets
Declining innovation in mature agents	Investment in next-generation contrast media

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Key Takeaways

• Market Stability: Isovue-250 maintains a dominant position in iodinated contrast agents, with consistent demand driven by diagnostic imaging needs.
• Clinical Trials Status: Focus predominantly on post-market safety data, with minimal ongoing research specific to Isovue-250.
• Competitive Position: Faces intense competition from newer, lower-osmolar contrast agents but benefits from brand recognition and proven safety profile.
• Growth Drivers: Primarily driven by global aging populations, expanding healthcare infrastructure, and technological advances in imaging.
• Future Outlook: Steady growth projected (~5% CAGR), with potential for innovation through formulation improvements and expanded indications.

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Frequently Asked Questions (FAQs)

1. Are there any recent clinical trials evaluating alternative formulations of Isovue-250?
   No substantial new clinical trials have been initiated; development efforts are focused on refining existing formulations and exploring lower-osmolar or iso-osmolar variants for improved safety.

2. How does Isovue-250 compare in safety to competing contrast agents?
   It has a well-established safety record, with adverse reaction rates below 1%. Newer agents with lower osmolality are considered safer for patients with kidney risks, but Isovue-250 remains widely trusted.

3. What regulatory challenges impact the global market for Isovue-250?
   Strict pharmacovigilance requirements and contraindications related to allergy and renal impairment lead to continual labelling updates, but approval remains stable across major jurisdictions.

4. What is the impact of emerging technologies, like artificial intelligence, on the demand for iodinated contrast media?
   AI-enhanced imaging increases demand for high-quality contrast agents. Isovue-250’s broad profile aligns well with these advanced imaging protocols.

5. What growth areas could extend Isovue-250’s market share?
   Expansion into emerging markets, development of lower-osmolar formulations, and integrated safety tracking through digital health tools offer growth potential.

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References

1. GE Healthcare. (2022). Contrast Media Portfolio Overview.
2. MarketWatch. (2022). Global Contrast Media Market Report.
3. FDA. (2023). Drug Approvals and Safety Information.
4. IQVIA. (2022). Healthcare Market Data.
5. Radiology Society of North America. (2022). Trends in Diagnostic Imaging.

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This comprehensive review serves as a strategic resource for healthcare providers, investors, and policymakers overseeing the use and market of Isovue-250 in diagnostic imaging.