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: United States
Active Clinical Trial Count: 1
Highest Development Phases
Phase 1: Breast Cancer|Breast Diseases|Fibroadenoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
Abbreviated MRI Protocol | P1 |
Completed |
Breast Diseases|Breast Cancer|Fibroadenoma |
2023-06-30 |