Bayer wins FDA approval for Ambelvist, the lowest-dose MRI contrast agent

The U.S. Food and Drug Administration (FDA) approved Bayer’s new intravenous macrocyclic gadolinium-based contrast agent, gadoquatrane. Bayer will market the agent under the brand name Ambelvist™.

The approval covers contrast-enhanced magnetic resonance imaging (MRI) for adult and pediatric patients. Medical professionals will use the agent to detect and visualize lesions with abnormal vascularity.

Ambelvist™ is the lowest-dose macrocyclic gadolinium-based contrast agent approved in the United States. This low-dose formulation reduces patient exposure to gadolinium while maintaining diagnostic efficacy.

Data from the global pivotal Phase III QUANTI clinical studies supported the FDA's decision. This U.S. clearance follows an initial approval in Japan in March 2026.