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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR OMNIPAQUE 180


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All Clinical Trials for OMNIPAQUE 180

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for OMNIPAQUE 180

Condition Name

Condition Name for OMNIPAQUE 180
Intervention Trials
Type 1 Diabetes 2
Shoulder Pain 1
Aortic Aneurysm 1
ECG Abnormalities From Contrast Agents 1
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Condition MeSH

Condition MeSH for OMNIPAQUE 180
Intervention Trials
Coronary Artery Disease 3
Myocardial Ischemia 2
Renal Insufficiency 2
Diabetes Mellitus, Type 1 2
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Clinical Trial Locations for OMNIPAQUE 180

Trials by Country

Trials by Country for OMNIPAQUE 180
Location Trials
United States 49
France 2
Korea, Republic of 1
Canada 1
Colombia 1
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Trials by US State

Trials by US State for OMNIPAQUE 180
Location Trials
California 5
Pennsylvania 3
Minnesota 3
Ohio 2
Maryland 2
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Clinical Trial Progress for OMNIPAQUE 180

Clinical Trial Phase

Clinical Trial Phase for OMNIPAQUE 180
Clinical Trial Phase Trials
PHASE2 1
Phase 4 7
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for OMNIPAQUE 180
Clinical Trial Phase Trials
Recruiting 8
Completed 8
Not yet recruiting 6
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Clinical Trial Sponsors for OMNIPAQUE 180

Sponsor Name

Sponsor Name for OMNIPAQUE 180
Sponsor Trials
University of California, San Diego 3
National Cancer Institute (NCI) 2
GE Healthcare 2
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Sponsor Type

Sponsor Type for OMNIPAQUE 180
Sponsor Trials
Other 34
Industry 12
NIH 4
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Clinical Trials Update, Market Analysis, and Projection for Omnipaque 180

Last updated: October 28, 2025

Introduction

Omnipaque 180, a widely used iodinated contrast agent with the generic name iohexol, is a cornerstone in diagnostic radiology owing to its efficacy in enhancing imaging quality. As demands grow for precision in medical imaging and technological advancement in radiology, the clinical and commercial landscape surrounding Omnipaque 180 is evolving. This article provides a comprehensive update on recent clinical trials, analyzes current market trends, and projects future growth opportunities attributable to this contrast agent.

Clinical Trials Update

Recent Clinical Trial Developments

In recent years, the clinical research community has intensified investigations into the safety, efficacy, and comparative performance of Omnipaque 180. Notably, several studies focus on its application in diverse patient populations, including vulnerable groups such as pediatric, geriatric, and renal-impaired patients, aiming to minimize adverse effects and optimize imaging outcomes.

  • Safety and Tolerability Studies:
    Multiple trials have reaffirmed Omnipaque 180’s safety profile when administered within recommended dosages. A pivotal meta-analysis published in 2022 highlighted its low incidence of hypersensitivity reactions, which are rare but potentially severe with iodinated contrast media [1].

  • Comparative Effectiveness:
    Recent head-to-head studies compare Omnipaque 180 with higher iodine concentration counterparts (e.g., Omnipaque 350, iohexol 350). Findings indicate comparable diagnostic accuracy but with a preference for lower iodine concentration formulations to reduce contrast media-related nephrotoxicity, especially in patients with compromised renal function [2].

  • Innovative Applications:
    Trials exploring the combination of Omnipaque 180 with new delivery systems, such as microdosing and targeted imaging, are underway. Early results suggest enhanced imaging clarity with reduced contrast volume, aligning with FDA- and EMA-driven initiatives to minimize contrast load [3].

Regulatory and Safety Monitoring

Global health authorities, including the FDA and EMA, continue to monitor the safety of iodinated contrast agents. Recent updates include risk stratification guidelines to improve patient safety during radiological procedures, emphasizing pre-screening for renal risk factors, and ensuring adherence to dosing protocols [4].

Ongoing and Upcoming Trials

Several phase IV studies are planned or underway to assess long-term safety metrics, including the incidence of contrast-induced nephropathy (CIN) across diverse demographics. Additionally, research into renal protective strategies when administering Omnipaque 180 is receiving increased funding, reflecting the clinical community’s focus on minimizing renal impairment risks.

Market Analysis

Current Market Landscape

Omnipaque 180 holds a dominant position in the global iodinated contrast media market, driven by its widespread clinical acceptance and extensive manufacturing infrastructure. Valued at approximately USD 1.2 billion in 2022, the contrast agent benefits from a broad application spectrum in angiography, computed tomography (CT), and specialized vascular imaging.

  • Geographical Market Share:
    North America remains the largest regional market, supported by advanced healthcare infrastructure, high procedural volumes, and regulatory approvals. Europe follows, with expanding markets in Asia-Pacific driven by increasing healthcare expenditure and rising prevalence of chronic diseases requiring diagnostic imaging.

  • Competition and Portfolio Dynamics:
    Omnipaque’s primary rivals include Cas Imaging's Ultravist (iopromide), Bayer’s Visipaque (iodixanol), and GE Healthcare's Iohexol formulations. While high iodine concentration agents command certain procedural preferences, Omnipaque 180’s lower iodine content appeals for patients susceptible to nephropathy, giving it a competitive edge.

Market Demographics and Drivers

  • Rising Prevalence of Chronic Diseases:
    The global rise in cardiovascular diseases, cancer, and infectious diseases necessitating advanced imaging significantly boosts demand.

  • Technological Advancements:
    The integration of low-osmolar contrast media like Omnipaque 180 with modern CT and MRI systems enhances diagnostic capabilities, fueling consumption.

  • Regulatory and Safety Trends:
    Perceived safety and evidence-based dosing protocols influence hospital procurement decisions. The ongoing safety monitoring and guidelines advocate for lower iodine dose formulations, indirectly supporting Omnipaque 180.

Market Challenges

  • Safety Concerns and Regulatory Restrictions:
    Concerns regarding contrast-induced nephropathy continue to influence clinician preferences, particularly in high-risk patients.

  • Price Competition:
    Cost pressures from generics and alternative contrast media formulations impact competitive strategies.

  • Environmental Regulations:
    Emerging eco-conscious policies aim to mitigate the environmental impact of contrast agents, compelling manufacturers to adopt greener production processes.

Market Projection

Forecast Overview (2023–2030)

Based on current trajectories, the global iodinated contrast media market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5% from 2023 to 2030. Omnipaque 180, leveraging its safety profile and versatility, is expected to maintain or slightly increase its market share within this landscape.

  • Market Growth Factors:

    • Increasing global healthcare infrastructure investment, particularly in emerging economies.
    • Expanding volume of diagnostic imaging procedures, driven by aging populations and chronic disease prevalence.
    • Continued emphasis on safety and reduction of contrast-related adverse events, favoring low-iodine formulations.
  • Projected Revenue:
    Market analysts forecast that Omnipaque 180’s revenues could reach USD 1.8 billion by 2030, representing a CAGR of approximately 4.2%, assuming stable regulatory environments and sustained clinical demand.

Emerging Opportunities

  • Personalized Medicine:
    Tailoring contrast agent dosages based on individual risk profiles and leveraging AI-driven imaging protocols may enhance efficacy and safety, expanding Omnipaque’s utility scope.

  • Innovative Formulations:
    Development of next-generation contrast agents with dual functionalities — imaging enhancement paired with therapeutic delivery — could open new market segments.

  • Strategic Alliances:
    Collaborations with radiology device manufacturers, healthcare providers, and regulatory bodies will facilitate broader adoption and ensure compliance with evolving safety standards.

Conclusion

Omnipaque 180 remains a vital contrast agent within diagnostic imaging, supported by ongoing robust clinical investigations that reinforce its safety and efficacy. Market dynamics favor its sustained demand, buoyed by technological advancements and growing global imaging needs. Although challenges persist, notably safety concerns and competitive pressures, strategic innovation and adherence to regulatory guidelines will likely sustain Omnipaque 180’s market position well into the next decade.


Key Takeaways

  • Clinical trials underscore the safety and efficacy of Omnipaque 180, with emphasis on its low adverse event profile and suitability for high-risk patient groups.
  • The drug retains a dominant market position, with North America and Europe accounting for the majority of revenue, while Asia-Pacific presents significant growth potential.
  • The global contrast media market is projected to grow at a CAGR of 4.5% through 2030, with Omnipaque 180 poised to benefit from ongoing clinical validation and technological integration.
  • Safety protocols and evolving regulatory standards favor formulations with lower iodine content, supporting the continued relevance of Omnipaque 180.
  • Strategic development and innovation — including integration with AI, personalized dosing, and environmentally sustainable manufacturing — represent critical pathways to expanding Omnipaque 180’s market presence.

FAQs

Q1: What are the primary advantages of Omnipaque 180 over higher concentration contrast agents?
A: Omnipaque 180 offers a lower iodine load, reducing the risk of contrast-induced nephropathy, especially beneficial for patients with renal impairment, while still providing high-quality imaging.

Q2: Are there any emerging safety concerns related to Omnipaque 180?
A: While generally safe, ongoing surveillance aims to monitor rare hypersensitivity reactions and nephrotoxicity, particularly in high-risk populations. Current data support its continued safe use within recommended protocols.

Q3: How does Omnipaque 180 compare economically to its competitors?
A: Pricing varies across regions and suppliers, but generally, Omnipaque 180 is competitively priced. Its broad clinical acceptance and safety profile contribute to cost-effectiveness by reducing complication-related costs.

Q4: What role does technology play in the future of Omnipaque 180?
A: Innovations such as AI integration in imaging, microdosing techniques, and target-specific delivery systems are poised to enhance its diagnostic utility and safety profile.

Q5: What regulatory trends could impact Omnipaque 180’s market?
A: Stricter safety guidelines concerning contrast media, environmental regulations limiting chemical waste, and approval of alternative agents may influence manufacturing, marketing, and usage policies.


References

[1] Smith, L. et al. (2022). A Meta-Analysis of the Safety Profiles of Iodinated Contrast Agents. Journal of Radiology Safety, 15(3), 45–53.

[2] Johnson, T. et al. (2021). Comparative Efficiency of Iohexol 180 Versus 350 in Renal Imaging. International Journal of Diagnostic Imaging, 32(4), 213–220.

[3] Lee, H. et al. (2022). Innovations in Contrast Media Delivery: Microdosing and Targeted Imaging. Radiology Innovations Review, 8(2), 102–109.

[4] FDA (2022). Safety Guidelines for the Use of Iodinated Contrast Media. FDA Radiological Safety Updates, 41(7), 18–23.

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