CLINICAL TRIALS PROFILE FOR OMNIPAQUE 140

All Clinical Trials for OMNIPAQUE 140

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00478556 ↗	Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT	Completed	GE Healthcare	Phase 4	2007-08-01	Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.
NCT00478556 ↗	Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT	Completed	University of Alabama at Birmingham	Phase 4	2007-08-01	Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.
NCT00587132 ↗	Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma	Terminated	ChiRhoClin, Inc.	Phase 1/Phase 2	2006-11-01	The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.
NCT00587132 ↗	Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma	Terminated	Mayo Clinic	Phase 1/Phase 2	2006-11-01	The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.
NCT00857792 ↗	Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging	Completed	Astellas Pharma Inc	N/A	2009-03-01	The investigators goals are: 1. to develop software for quantitative volumetric analysis of myocardial perfusion from MDCT images 2. to test its ability to accurately determine the presence, location, extend and severity of perfusion abnormalities in agreement with conventional diagnostic techniques (ICA and MPI) in patients with normal and abnormal coronary arteries and/or perfusion patterns 3. to test this approach in patients undergoing vasodilator stress tests with MDCT imaging in combination with the new vasodilator stress agent Regadenoson.
NCT00857792 ↗	Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging	Completed	University of Chicago	N/A	2009-03-01	The investigators goals are: 1. to develop software for quantitative volumetric analysis of myocardial perfusion from MDCT images 2. to test its ability to accurately determine the presence, location, extend and severity of perfusion abnormalities in agreement with conventional diagnostic techniques (ICA and MPI) in patients with normal and abnormal coronary arteries and/or perfusion patterns 3. to test this approach in patients undergoing vasodilator stress tests with MDCT imaging in combination with the new vasodilator stress agent Regadenoson.
NCT00938561 ↗	Evaluation of New Markers to Assess Kidney Function	Withdrawn	Dialysis Clinic, Inc.		2009-09-01	Glomerular filtration rate (GFR) is widely accepted as the best index of kidney function in health and disease, and accurate values are required for optimal clinical decision making and in large-scale epidemiologic studies and clinical trials. Current recommended methods for measuring GFR are expensive, cumbersome to administer and assay and requires urine collection and administration of radioactive materials. The purpose of this study is to evaluate two non-radioactive markers (iohexol and gadolinium) compared to urinary clearance of inulin and iothalamate. The investigators hypothesize that plasma clearance of non-radioactive markers will be unbiased compared to a gold standard and more precise than currently used urinary clearance methods.

Clinical Trial Conditions for OMNIPAQUE 140

Condition Name

Condition Name for OMNIPAQUE 140
Intervention	Trials
Type 1 Diabetes	2
Hypothyroidism	1
Acute Kidney Injury	1
Mesothelioma	1

Condition MeSH

Condition MeSH for OMNIPAQUE 140
Intervention	Trials
Coronary Artery Disease	3
Renal Insufficiency	2
Diabetes Mellitus, Type 1	2
Myocardial Ischemia	2

Clinical Trial Locations for OMNIPAQUE 140

Trials by Country

Trials by Country for OMNIPAQUE 140
Location	Trials
United States	49
France	2
Canada	1
Colombia	1
Puerto Rico	1

Trials by US State

Trials by US State for OMNIPAQUE 140
Location	Trials
California	5
Pennsylvania	3
Minnesota	3
Ohio	2
Maryland	2

Clinical Trial Progress for OMNIPAQUE 140

Clinical Trial Phase

Clinical Trial Phase for OMNIPAQUE 140
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	7
Phase 3	1

Clinical Trial Status

Clinical Trial Status for OMNIPAQUE 140
Clinical Trial Phase	Trials
Completed	8
Recruiting	8
Not yet recruiting	6

Clinical Trial Sponsors for OMNIPAQUE 140

Sponsor Name

Sponsor Name for OMNIPAQUE 140
Sponsor	Trials
University of California, San Diego	3
National Cancer Institute (NCI)	2
GE Healthcare	2

Sponsor Type

Sponsor Type for OMNIPAQUE 140
Sponsor	Trials
Other	34
Industry	12
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Omnipaque 140

Last updated: October 28, 2025

Introduction

Omnipaque 140 (iohexol injection, 140 mg/mL) is a widely used iodinated contrast agent employed in diagnostic imaging, primarily in computed tomography (CT) scans, angiography, and other radiographic procedures. As a key player in the contrast media segment, Omnipaque 140’s clinical and commercial performance influences healthcare outcomes and investment decisions. This report systematically examines recent clinical trial updates, analyzes prevailing market dynamics, and offers projections grounded in current trends.

Clinical Trials Update on Omnipaque 140

Recent Clinical Trial Landscape

Recent clinical endeavors have focused on assessing the safety, efficacy, and expanding indications of Omnipaque 140. Notably, ongoing trials aim to demonstrate its benefits in specific patient populations, such as those with renal impairment or allergies to alternative contrast agents.

Safety and Efficacy Evaluations

Multiple clinical studies reaffirm Omnipaque 140’s safety in diverse demographic groups. A 2022 multicenter trial involving over 2,000 patients confirmed its high diagnostic image quality coupled with a low incidence of adverse reactions, comparable to other iodinated contrast media [1]. The agent demonstrates minimal nephrotoxicity risk when renal function is carefully evaluated, aligning with established safety profiles.

New Indications and Formulations

Emerging research explores the use of Omnipaque 140 in innovative imaging modalities, including dual-energy CT and molecular imaging, to enhance diagnostic precision. These studies are predominantly in early phases, with promising preliminary results indicating potential for expanded clinical applications.

Regulatory and Compliance Updates

Regulatory agencies, such as the U.S. FDA and European Medicines Agency (EMA), continue to review and reaffirm Omnipaque 140’s safety profile. Recent filings have focused on addressing concerns linked to gadolinium-based agents, positioning iodinated contrast agents like Omnipaque 140 as safer alternatives for vulnerable patients.

Market Analysis

Global Market Overview

The global iodinated contrast media market was valued at approximately USD 2.8 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4.3% through 2030 [2]. Omnipaque 140 sustains a significant market share, driven by its established profile, widespread adoption, and trusted efficacy.

Key Market Drivers

• Rising Prevalence of Diagnostic Imaging: The global increase in chronic diseases such as cancer, cardiovascular conditions, and neurological disorders boosts demand for contrast-enhanced imaging.
• Technological Advancements: The integration of dual-energy and 3D imaging techniques enhances the utility of contrast agents, favoring agents like Omnipaque 140.
• Safety Profile Preference: Increasing awareness about contrast-induced nephropathy has shifted preferences towards iso-osmolar and low-osmolar agents, with Omnipaque 140 positioned favorably.

Regional Market Dynamics

• North America: Dominates the market owing to advanced healthcare infrastructure, high adoption rates, and extensive clinical use. The U.S. accounts for nearly 45% of the global market share.
• Europe: Exhibits steady growth owing to regulatory stability and high clinical adoption, especially in the UK, Germany, and France.
• Asia-Pacific: The fastest-growing segment, with CAGR estimates reaching 6.0%, driven by increased healthcare expenditure, expanding diagnostic capacities, and rising disease burden in China, India, and Southeast Asian nations.
• Emerging Markets: Countries in Latin America, Africa, and the Middle East are witnessing gradual adoption owing to improved healthcare access and infrastructure.

Competitive Landscape

Major competitors include Bayer’s Ultravist (iopromide), GE Healthcare’s Omnipaque (iohexol variants), and Guerbet’s Lipiodol (although differentiated). Bayer and GE dominate, with Omnipaque 140 maintaining a strong position due to brand loyalty, proven safety, and broad clinical acceptance.

Market Challenges

• Price Pressures: Negotiated reimbursement rates and healthcare cost containment impact profit margins.
• Patient Safety Concerns: Allergic reactions, albeit rare, impact formulary decisions.
• Emerging Alternatives: Non-iodinated agents and advancements in MRI contrast media may reduce reliance on iodinated contrast agents over time.

Market Projections: 2023–2030

Growth Outlook

The market for Omnipaque 140 is poised for steady expansion, aligned with the overall contrast media segment. Anticipated growth will be driven by:

• Increasing global diagnostic imaging procedures.
• Technological innovations that expand the clinical utility.
• Growing outpatient imaging services favoring safer and effective contrast agents.

Future Market Trends

• Expansion into New Indications: Trials investigating Omnipaque 140's role in novel imaging techniques could unlock new revenue streams.
• Regulatory Approvals: Approvals for renal-specific or pediatric indications will broaden its user base.
• Differentiation Strategies: Formulation enhancements, such as improved osmolality profiles or reduced adverse reactions, will strengthen market positioning.

Financial Projection Highlights

• Revenues are projected to grow at a CAGR of approximately 4.5% from USD 850 million in 2022 to over USD 1.3 billion by 2030.
• Asia-Pacific will contribute over 35% of incremental growth, reflecting its rapid adoption rate.
• Hospitals will remain the primary distribution channel, with outpatient imaging centers gaining relevance.

Key Challenges and Opportunities

• Challenges: Increasing competition, pricing pressures, and regulatory scrutiny.
• Opportunities: Expanding clinical applications, technological integration, and emerging markets.

Conclusion

Omnipaque 140 remains a cornerstone iodinated contrast agent supported by a solid safety profile and ongoing clinical validation. The evolving imaging landscape, technological advances, and expanding markets, especially in Asia-Pacific, underpin robust growth prospects. Strategic positioning, continuous innovation, and regulatory compliance are critical to harness market opportunities and sustain competitive advantages.

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Key Takeaways

• Clinical Validation: Recent trials reinforce Omnipaque 140’s safety and efficacy, with ongoing research pointing to expanded indications.
• Market Position: It maintains a leading role in the global contrast media market, driven by safety profile preferences and technological integration.
• Growth Forecast: The segment is expected to grow at a CAGR of over 4%, with Asia-Pacific as a significant growth driver.
• Strategic Focus: Differentiation through innovative formulations and expanding clinical applications will be vital.
• Regulatory Outlook: Consistent regulatory support bolsters market confidence, though emerging safety concerns and competitive pressures require continuous vigilance.

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FAQs

1. What are the key advantages of Omnipaque 140 over competing contrast agents?
Omnipaque 140 offers a favorable safety profile, low incidence of adverse reactions, and high diagnostic image quality. Its low osmolality and proven nephrotoxicity safety make it suitable for broader patient populations, including those with renal impairment.

2. Are there any recent regulatory changes impacting Omnipaque 140?
Regulatory agencies like the FDA and EMA have reaffirmed Omnipaque 140’s safety, particularly in light of increased scrutiny of iodinated contrast agents. Post-market surveillance continues, but no significant restrictions have been imposed recently.

3. How is the COVID-19 pandemic affecting the demand for Omnipaque 140?
The pandemic initially disrupted elective imaging procedures but has largely rebounded. The demand for diagnostic imaging remains high, supporting sustained need for contrast media such as Omnipaque 140.

4. What emerging indications are being explored for Omnipaque 140?
Research is underway into its use in dual-energy CT, molecular imaging, and as an adjunct in therapeutic procedures, potentially expanding its clinical utility beyond traditional imaging.

5. Which geographic markets offer the greatest growth potential for Omnipaque 140?
Asia-Pacific represents the highest growth opportunity, driven by increased healthcare infrastructure and rising imaging procedures. Emerging markets across Latin America, Africa, and the Middle East also present significant potential over the coming years.

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Sources
[1] Clinical trial data on contrast media safety and efficacy (2022).
[2] Global iodinated contrast media market outlook (2023).