Gadoquatrane: First Approval.

Gadoquatrane (AMBELVIST®) is a paramagnetic, tetrameric, next-generation, high-relaxivity, low-dose macrocyclic gadolinium-based contrast agent (GBCA) developed by Bayer for use with magnetic resonance imaging (MRI). It received its first global approval for contrast enhancement in MRI of the brain and spinal cord, as well as the other parts of the body (trunk and extremities) in March 2026 in Japan. Subsequently, it was approved for use with MRI to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) in June 2026 in the USA. It has also been approved in adults and children of all ages including neonates for contrast enhancement in MRI to detect and visualise known or suspected pathology in the CNS (brain, spine, and associated tissues) and the body (head and neck, thorax including breast, abdomen, pelvis, and extremities) in July 2026 in Canada. Gadoquatrane has been submitted for regulatory review in the EU and China. This article summarizes the milestones in the development of gadoquatrane leading to its approval.