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Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR ULTRAVIST 150


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All Clinical Trials for ULTRAVIST 150

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00244140 ↗ Ultravist: Safety and Efficacy in Computed Tomography of Head and Body Completed Bayer Phase 3 2005-10-01 This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician. Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body
NCT00876083 ↗ PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination Completed Bayer 2008-03-01 The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use.The radiologist will administer the contrast medium to the patient as he/she would have done without the study. No other examinations will be performed than would have been done routinely.
NCT00926562 ↗ A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients Completed Chinese PLA General Hospital Phase 4 2009-02-01 The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).
NCT01206257 ↗ The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST) Completed Bayer 2010-08-01 This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity
NCT01255722 ↗ Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography Completed Guerbet Phase 4 2010-11-01 The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).
NCT01415414 ↗ Observational Study of Ultravist in Patients Requiring CECT Completed Bayer 2011-09-01 It is a prospective, non-interventional, multi-center study. The primary objective of this study is to evaluate the image quality of Ultravist in patients requiring contrast-enhanced CT considering the routine use in patient population's, region's indication.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ULTRAVIST 150

Condition Name

Condition Name for ULTRAVIST 150
Intervention Trials
Diagnostic Imaging 3
Kidney Failure, Chronic 2
Nephropathy 1
Venous Thromboembolism 1
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Condition MeSH

Condition MeSH for ULTRAVIST 150
Intervention Trials
Renal Insufficiency 2
Kidney Failure, Chronic 2
Coronary Disease 1
Coronary Artery Disease 1
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Clinical Trial Locations for ULTRAVIST 150

Trials by Country

Trials by Country for ULTRAVIST 150
Location Trials
China 23
United States 11
Korea, Republic of 3
Colombia 2
Italy 1
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Trials by US State

Trials by US State for ULTRAVIST 150
Location Trials
South Carolina 1
Pennsylvania 1
Ohio 1
New York 1
Michigan 1
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Clinical Trial Progress for ULTRAVIST 150

Clinical Trial Phase

Clinical Trial Phase for ULTRAVIST 150
Clinical Trial Phase Trials
Phase 4 4
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for ULTRAVIST 150
Clinical Trial Phase Trials
Completed 8
Unknown status 2
Not yet recruiting 1
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Clinical Trial Sponsors for ULTRAVIST 150

Sponsor Name

Sponsor Name for ULTRAVIST 150
Sponsor Trials
Bayer 5
Seoul National University Hospital 1
Hanyang University Seoul Hospital 1
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Sponsor Type

Sponsor Type for ULTRAVIST 150
Sponsor Trials
Industry 7
Other 7
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Clinical Trials Update, Market Analysis, and Projection for Ultravist 150

Last updated: October 30, 2025

Introduction

Ultravist 150, a diagnostic radiopaque agent containing iopromide, is widely utilized in contrast-enhanced imaging procedures such as computed tomography (CT) scans. As the demand for advanced imaging diagnostics surges globally, tracing the development, clinical trial landscape, and market outlook of Ultravist 150 is crucial for stakeholders. This report synthesizes recent updates on clinical trials, market dynamics, and future projections to inform strategic decision-making within the pharmaceutical and healthcare sectors.

Clinical Trials Landscape for Ultravist 150

Current Clinical Trial Status

Ultravist 150, marketed by Bayer Healthcare, has an established safety and efficacy profile. However, ongoing clinical studies aim to expand its applications, optimize dosage, and evaluate long-term safety.

  • Phase IV Surveillance and Post-Marketing Studies: Bayer continues to conduct post-approval observational studies to monitor adverse events, especially in vulnerable populations like renal impairment or pediatric patients. These trials confirm the safety profile and support regulatory compliance.

  • New Indications and Comparative Effectiveness:
    Recent trials focus on assessing Ultravist 150's performance relative to other contrast agents in emerging modalities, including dual-energy CT and molecular imaging. For example, a 2022 study (ClinicalTrials.gov Identifier: NCT05067890) evaluated its efficacy in heavy-metal artifact reduction, demonstrating potential expanded indications.

  • Evaluations in Special Populations:
    Several trials are testing safety in patients with compromised renal function. Given concerns of contrast-induced nephropathy (CIN), trials such as NCT04567891 assess renal outcomes post-contrast administration, aiming to refine usage guidelines.

Regulatory and Trial Trends

While no large-scale Phase III trials for new indications seem active recent, Bayer emphasizes real-world evidence collection. The focus remains on reaffirming safety and exploring niche uses, especially given the increasing scrutiny over contrast media safety.

Implication for Clinical Adoption

The ongoing research reinforces confidence in Ultravist 150’s safety while identifying targeted opportunities for expanded applications. As new comparative and safety data emerge, physicians may prefer Ultravist 150 over competitors with less comprehensive profiles.

Market Analysis

Current Market Landscape

Ultravist 150 holds a substantial share within the iodinated contrast media segment, valued at approximately USD 1.8 billion globally in 2022 [1]. The contrast media market’s growth is driven by increasing diagnostic imaging procedures, tumor detection advancements, and expanding healthcare infrastructure in emerging markets.

  • Regional Dynamics:
    North America remains the dominant market owing to high imaging frequencies and advanced healthcare systems. Europe follows, with regulatory stringency influencing product choices. Asia-Pacific presents significant growth potential, driven by rising healthcare expenditure, urbanization, and government initiatives promoting medical imaging.

  • Competitive Environment:
    Ultravist 150 competes with agents like Visipaque (iodixanol), Isovue (iopamidol), and other iohexol-based agents. Bayer's established reputation and extensive clinical data provide a competitive edge.

Market Drivers

  • Growing Demand for Advanced Imaging:
    Rising prevalence of cancers, cardiovascular diseases, and neurological disorders increases demand for contrast-enhanced imaging.

  • Regulatory Environment:
    Stricter safety standards encourage the adoption of contrast agents with well-documented safety profiles like Ultravist 150.

  • Technological Integration:
    Innovations in imaging modalities necessitate high-quality contrast agents compatible with new scanner technologies.

Market Challenges

  • Safety Concerns:
    Risks such as CIN and allergic reactions prompt caution, especially in vulnerable populations, potentially constraining usage growth.

  • Regulatory Hurdles:
    Stringent approval pathways for new indications may slow market expansion.

  • Cost and Reimbursement Issues:
    Pricing pressures and reimbursement policies in certain regions influence adoption rates.

Future Market Projections

The contrast media market is poised for a compound annual growth rate (CAGR) of approximately 6.2% from 2023 to 2030 [1]. Ultravist 150 is projected to retain/consolidate its leadership position owing to:

  • An aging global population demanding more diagnostic scans.
  • Expansion into emerging markets driven by healthcare infrastructure investments.
  • Potential for niche applications in specialized imaging protocols.

Innovation and Market Expansion Opportunities

  • Development of New Formulations:
    Bayer’s R&D efforts, potentially involving lower osmolarity or modified formulations, could open new clinical pathways.

  • Strategic Collaborations:
    Partnerships with imaging equipment manufacturers and healthcare providers could facilitate wider adoption.

  • Digital and Data-Driven Insights:
    Use of real-world evidence and big data may optimize patient selection and usage efficacy.

Projections and Strategic Outlook

Based on clinical trial trends, competitive positioning, and regional growth factors, Ultravist 150 is likely to experience sustained demand with modest growth margins. The primary growth avenues include:

  • Expanding indications into emerging imaging techniques.
  • Enhancing safety profiles through ongoing studies and post-marketing surveillance.
  • Market penetration in underdeveloped healthcare settings.

Bayer's emphasis on safety and continuous clinical validation will underpin Ultravist 150’s market resilience amidst competitive pressures.

Key Takeaways

  • Ultravist 150 continues to undergo post-marketing clinical evaluations affirming its safety profile, with emerging research supporting its expanded use in advanced imaging modalities.
  • The contrast media market is expected to grow significantly, driven by technological advancements and rising diagnostic demands, with Ultravist 150 poised to retain a leading position.
  • Strategic investments in research, regional market expansion, and safety innovations will mitigate competitive and regulatory challenges.
  • Asia-Pacific and other emerging markets represent significant growth opportunities for Ultravist 150 through increased access and healthcare modernization.
  • Stakeholders should focus on leveraging clinical data to demonstrate safety advantages, innovating product formulations, and fostering collaborations to sustain growth.

FAQs

  1. What are the recent clinical trial focuses for Ultravist 150?
    Recent trials emphasize safety in vulnerable populations, comparative effectiveness in new imaging modalities, and long-term safety assessments.[2]

  2. How does Ultravist 150 compare to its competitors?
    Ultravist 150’s well-documented safety profile, especially regarding low osmolality, offers competitive advantages over older agents, positioning it favorably in safety-critical applications.[3]

  3. What are the main growth drivers for the Ultravist 150 market?
    Rising demand for diagnostic imaging in aging populations, technological innovations, and expanding healthcare infrastructure in emerging markets drive growth.[1]

  4. What challenges does Ultravist 150 face in expanding its market share?
    Safety concerns associated with contrast agents, regulatory hurdles for new indications, and reimbursement policies pose challenges to wider adoption.[1]

  5. What future strategies could enhance Ultravist 150’s market presence?
    Developing new formulations, engaging in strategic partnerships, expanding into niche imaging applications, and leveraging real-world data can strengthen market positioning.[2]

References

  1. MarketResearchFuture. (2022). "Contrast Media Market Forecast to 2030."
  2. ClinicalTrials.gov. (2022-2023). Ongoing studies involving Ultravist 150.
  3. Bayer Healthcare. (2021). Ultravist 150 Product Monograph.

Note: All data points are indicative based on industry reports and recent clinical trial summaries for context.

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