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: LEVERKUSEN 2M D-51368
Company CEO: Werner Baumann
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Bulgaria, Canada, China, Czech Republic, France, Germany, Hungary, Italy, Japan, Korea, Poland, Sweden, Turkey, United Kingdom, United States
Active Clinical Trial Count: 5
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Other
Phase 2: Brain Diseases|Spinal Cord Diseases|Spinal Diseases
Phase 1: Cystitis, Interstitial
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| STUDY22030048 | P1 |
Completed |
Cystitis, Interstitial |
2025-05-20 |
2025-05-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
| NCT06224543 | P1 |
Enrolling by invitation |
Other |
2024-12-31 |
2024-02-09 |
Primary Endpoints|Treatments |
|
| JapicCTI-205211 | P2 |
Active |
Spinal Cord Diseases|Spinal Diseases|Brain Diseases |
2021-12-27 |
|||
| Quanti OBR | P3 |
Completed |
Other |
2024-05-31 |
21% |
2024-07-23 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| Quanti CNS | P3 |
Completed |
Other |
2024-05-30 |
21% |
2024-07-23 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |