← Back to The Docket JUN 15 2026
APPROVED · 46 DAYS AGO
— Ambelvist (gadoquatrane)
$BAYRY
for MRI contrast enhancement (CNS and non-CNS body regions)
NDA
FDA approved Ambelvist (gadoquatrane) for contrast-enhanced MRI to detect lesions with abnormal vascularity in the CNS and non-CNS body regions. Dosed at 0.01 mmol/kg — the lowest-dose macrocyclic gadolinium-based contrast agent approved in the United States.
About
Ambelvist is a gadolinium-based contrast agent used to improve the clarity of magnetic resonance imaging (MRI) scans. It works by altering the magnetic properties of water molecules in the body, which makes areas with unusual blood flow appear brighter and more distinct on the resulting images. This enhanced visibility helps radiologists better detect and evaluate lesions in both the central nervous system and throughout the body.
Pivotal trial
Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI). MRI is used by doctors to create detailed images of the inside of the body to identify health problems
Source: ClinicalTrials.gov