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: *
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: Europe
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, Czech Republic, France, Germany, Hungary, Italy, Poland, South Korea, Spain, United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Aortic Diseases|Kidney Diseases|Peripheral Vascular Diseases
Phase 2: Lung Diseases, Interstitial
Phase 1: Breast Cancer|Breast Diseases|Fibroadenoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04341129 |
Abbreviated MRI Protocol | P1 |
Completed |
Breast Cancer|Fibroadenoma|Breast Diseases |
2023-06-30 |
2023-12-06 |
Primary Endpoints |
|
NCT05417776 |
2022P001087 | P2 |
Recruiting |
Lung Diseases, Interstitial |
2026-04-01 |
12% |
2025-05-10 |
|
NCT07348640 |
GDX-102 - GDX-44-017 | P3 |
Not yet recruiting |
Peripheral Vascular Diseases|Kidney Diseases|Aortic Diseases |
2027-12-31 |
2026-01-17 |
Primary Endpoints|Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/25/2025 |
News Article |
FDA Approves Expanded Indication for Max 3™ Syringeless MR Injector from Bracco |
|
11/10/2025 |
News Article |
Bracco Shapes the Future of Radiology at RSNA 2025 Annual Meeting |
|
09/13/2024 |
News Article |
Zydus announces exclusive licensing and supply agreement for two Gadolinium based Magnetic Resonance Imaging (MRI) injectable, contrast agents in the US |
|
02/09/2024 |
News Article |
Companion Diagnostics (CDx) Market Report 2024-2034 - High Capital Investment and Low Cost-benefit Ratio to Challenge Industry Growth |