← Back to The Docket JUN 15 2026
APPROVED · 106 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 contrast agent used to improve the clarity of MRI scans. It contains gadolinium, a metal that interacts with the MRI's magnetic field to brighten the appearance of tissues with unusual blood flow. This enhancement helps doctors more clearly see potentially problematic lesions in both the brain and body during imaging.
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