Posted by Michael Wonder on 16 Jun 2026
Bayer’s Ambelvist (gadoquatrane) receives FDA approval for contrast-enhanced MRI to detect and visualise lesions with abnormal vascularity in the central nervous system and non-CNS body region
15 June 2026 - Approval is supported by data from the Phase 3 QUANTI clinical studies, which demonstrated efficacy at a fraction of the dose compared to mGBCAs dosed at 0.1 mmol Gd/kg body weight.
Bayer today announced that the US FDA approved Ambelvist (gadoquatrane), a new, intravenous macrocyclic gadolinium-based contrast agent (mGBCA) indicated for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates.
