Product Description
Gadoteric acid is a macrocycle-structured gadolinium-based MRI contrast agent. It is composed of the organic acid DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid) used for its chelating properties, and gadolinium (Gd3+). Gadoteric acid, as the FDA approved product Dotarem, is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Gadoteric-acid)
Mechanisms of Action: Contrast Agent
Novel Mechanism: No
Modality: Diagnostic Agent
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: Algeria | Australia | Austria | Belgium | Bosnia | Bulgaria | Canada | Chile | China | Cyprus | Czech | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Malta | Morocco | Netherlands | New Zealand | Norway | 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 | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Guerbet
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Korea, Poland, South Korea, Sweden, Taiwan, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: Brain Diseases|Other|Spinal Cord Diseases|Spinal Diseases
Phase 2: Lung Diseases, Interstitial|Tinea
Phase 1: Breast Cancer|Breast Diseases|Fibroadenoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2022P001087 | P2 |
Recruiting |
Lung Diseases, Interstitial |
2025-04-01 |
|
| SIFICB | P2 |
Unknown Status |
Tinea |
2025-02-01 |
|
| Quanti OBR | P3 |
Completed |
Other |
2024-05-31 |
66% |
| Quanti OBR | P3 |
Completed |
Other |
2024-05-31 |
66% |
| Quanti OBR | P3 |
Completed |
Other |
2024-05-31 |
66% |
| Quanti OBR | P3 |
Completed |
Other |
2024-05-31 |
66% |
| Quanti CNS | P3 |
Completed |
Other |
2024-05-30 |
66% |
| Quanti CNS | P3 |
Completed |
Other |
2024-05-30 |
66% |
| Quanti CNS | P3 |
Completed |
Other |
2024-05-30 |
66% |
| Quanti CNS | P3 |
Completed |
Other |
2024-05-30 |
66% |