Product Description
Gadobutrol injection is a magnetic resonance imaging (MRI) contrast agent that is used to help create a clear picture of the body during an MRI scan. (Sourced from: https://www.mayoclinic.org/drugs-supplements/gadobutrol-intravenous-route/description/drg-20074828)
Mechanisms of Action: Imaging
Novel Mechanism: No
Modality: Diagnostic Agent
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Malta | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Bayer
Company Location:
Company Founding Year: 1863
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Japan, United States
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Brain Diseases|Spinal Cord Diseases|Spinal Diseases
Phase 1: Other
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06224543 |
NCT06224543 | P1 |
Completed |
Other |
2025-07-07 |
2025-09-03 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
JapicCTI-205211 |
JapicCTI-205211 | P2 |
Active |
Spinal Cord Diseases|Spinal Diseases|Brain Diseases |
2021-12-27 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/27/2026 |
News Article |
The European Commission extended the Marketing Authorisation for Vueway® (gadopiclenol) in the European Union for use in pediatric patients under 2 years of age |
|
11/25/2025 |
News Article |
FDA Approves Expanded Indication for Max 3™ Syringeless MR Injector from Bracco |
|
11/19/2025 |
News Article |
Bracco Delivers 3 Million VUEWAY® Doses, Meeting Patient Demand for Lower-Dose MRI Contrast |
|
11/10/2025 |
News Article |
Bracco Shapes the Future of Radiology at RSNA 2025 Annual Meeting |