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Last Updated: May 22, 2025

CLINICAL TRIALS PROFILE FOR ULTRAVIST 370


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All Clinical Trials for Ultravist 370

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

Clinical Trial Conditions for Ultravist 370

Condition Name

Condition Name for Ultravist 370
Intervention Trials
Diagnostic Imaging 3
Kidney Failure, Chronic 2
Computed Tomography 1
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Condition MeSH

Condition MeSH for Ultravist 370
Intervention Trials
Renal Insufficiency 2
Kidney Failure, Chronic 2
Venous Thromboembolism 1
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Clinical Trial Locations for Ultravist 370

Trials by Country

Trials by Country for Ultravist 370
Location Trials
China 23
United States 11
Korea, Republic of 3
Colombia 2
Germany 1
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Trials by US State

Trials by US State for Ultravist 370
Location Trials
New York 1
Michigan 1
Massachusetts 1
Maryland 1
Illinois 1
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Clinical Trial Progress for Ultravist 370

Clinical Trial Phase

Clinical Trial Phase for Ultravist 370
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 370
Clinical Trial Phase Trials
Completed 8
Unknown status 2
Not yet recruiting 1
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Clinical Trial Sponsors for Ultravist 370

Sponsor Name

Sponsor Name for Ultravist 370
Sponsor Trials
Bayer 5
GE Healthcare 1
Chinese PLA General Hospital 1
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Sponsor Type

Sponsor Type for Ultravist 370
Sponsor Trials
Industry 7
Other 7
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Ultravist 370: Clinical Trials, Market Analysis, and Projections

Introduction to Ultravist 370

Ultravist 370, an iodine-based contrast agent developed by Bayer, is widely used in various radiological procedures to enhance the visibility of internal body structures. Here, we will delve into the clinical trials, market analysis, and future projections for this versatile medical product.

Clinical Trials and Efficacy

Diagnostic Efficacy

In double-blind clinical trials, Ultravist 370 has demonstrated diagnostic efficacy comparable to other nonionic and ionic radiographic contrast agents. These trials included evaluations in excretory urography, renal arteriography, cerebral arteriography, peripheral arteriography, and coronary arteriography, among others[4].

Specific Trial Outcomes

  • Coronary Arteriography and Left Ventriculography: Clinical trials involving Ultravist 370 mgI/mL showed excellent visualization ratings in patients with altered coronary artery perfusion and ventricular function. The results were comparable to those of iohexol and iopamidol[5].
  • Peripheral Venography: Trials evaluating Ultravist 240 mgI/mL in patients with venous disorders reported good or excellent visualization ratings in 99% of the patients, similar to the outcomes with iohexol and iopamidol[5].

Safety Profile

While Ultravist 370 has shown strong diagnostic efficacy, it is not without potential risks. It is contraindicated in patients with known hypersensitivity to the drug or manifest hyperthyroidism. Special caution is advised in patients with cyanotic and acyanotic heart disease, congestive heart failure, or elevated serum creatinine levels[4].

Market Analysis

Global Usage and Approval

Ultravist 370 is approved for use in over 100 countries and is applied more than 18 million times annually. It has recently received approval for use in contrast-enhanced mammography (CEM) in the European Union, expanding its portfolio in breast imaging[2].

Export and Trade Data

According to Volza's global export data, Ultravist 370 exports have shown a growth rate of 4% from March 2023 to February 2024 compared to the preceding year. Germany leads the world in Ultravist exports, followed by India and Turkey. Key importers include Argentina, India, and Colombia[3].

Revenue and Sales

Bayer's radiology products, including Ultravist, generated €1.8 billion in sales in 2021. The approval for CEM and other indications is expected to further boost sales and market presence[2].

Market Projections

Emerging Modalities

The approval for contrast-enhanced mammography (CEM) is a significant milestone, as CEM is an emerging modality that combines digital mammography with contrast agents to enhance breast cancer diagnosis and treatment planning. This expansion is likely to increase the demand for Ultravist 370 in the coming years[2].

Global Market Growth

Given the widespread use and continuous expansion of indications, Ultravist 370 is projected to maintain its strong market position. The global contrast agents market is expected to grow, driven by advancements in imaging technologies and increasing diagnostic needs.

Competitive Landscape

Ultravist 370 competes with other iodine-based contrast agents such as iohexol and iopamidol. However, its broad range of approved indications and recent expansion into CEM position it favorably in the market.

Regulatory and Approval Updates

Recent Approvals

The recent approval for CEM in the EU through the European Workshare Procedure is a significant regulatory update. This approval is expected to lead to national approvals in the EU in the first quarter of 2023, further solidifying Ultravist 370's presence in the European market[2].

Pharmacokinetics and Safety Considerations

Distribution and Elimination

Ultravist 370 is characterized by a steady-state volume of distribution of 16 L and minimal plasma protein binding (1%). It is primarily excreted through the renal route (97%), with only 2% excreted via the fecal route[1][4].

Special Populations

Special caution is advised when administering Ultravist 370 to children, especially those with asthma, cyanotic and acyanotic heart disease, or immature renal function. In elderly patients and those with severe cutaneous reactions, careful consideration is necessary[1][4].

Key Takeaways

  • Clinical Efficacy: Ultravist 370 has demonstrated strong diagnostic efficacy in various radiological procedures.
  • Market Presence: It is widely used globally, with recent approvals expanding its indications.
  • Safety Profile: While effective, it requires careful administration, especially in special populations.
  • Market Projections: Expected to grow with the increasing demand for advanced imaging modalities like CEM.
  • Regulatory Updates: Recent EU approval for CEM is a significant milestone.

FAQs

What is Ultravist 370 used for?

Ultravist 370 is an iodine-based contrast agent used in various radiological procedures, including CT scans, angiography, excretory urography, and recently approved for contrast-enhanced mammography (CEM).

What are the contraindications for Ultravist 370?

Ultravist 370 is contraindicated in patients with known hypersensitivity to the drug or manifest hyperthyroidism. It should not be used in myelography, cerebral ventriculography, or cisternography.

How is Ultravist 370 excreted from the body?

Ultravist 370 is primarily excreted through the renal route (97%), with only 2% excreted via the fecal route.

What are the recent market developments for Ultravist 370?

Ultravist 370 has recently been approved for use in contrast-enhanced mammography (CEM) in the European Union, expanding its portfolio in breast imaging.

Who are the major exporters of Ultravist 370?

Germany leads the world in Ultravist exports, followed by India and Turkey.

What is the projected market growth for Ultravist 370?

The market for Ultravist 370 is expected to grow, driven by the increasing demand for advanced imaging modalities and the recent approval for CEM.

Sources

  1. ULTRAVIST 370 Prescription & Dosage Information - MPR https://www.empr.com/drug/ultravist-370/
  2. Ultravistâ„¢ by Bayer now approved for contrast-enhanced mammography in EU https://www.bayer.com/media/en-us/ultravist-by-bayer-now-approved-for-contrast-enhanced-mammography-in-eu/
  3. Ultravist Exports from World - Volza.com https://www.volza.com/p/ultravist/export/
  4. ULTRAVIST - Product Monograph https://pdf.hres.ca/dpd_pm/00054785.PDF
  5. ULTRAVIST - accessdata.fda.gov https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020220s027lbl.pdf
Last updated: 2025-01-07

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