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Bayer : low-dose MRI contrast agent approved in U.S.
Bayer : low-dose MRI contrast agent approved in
About this update from Bayer Ag
15 June 2026 | 08:30 AM Europe/Amsterdam Bayer's low-dose MRI contrast agent approved in U.S. Not intended for U.S. and UK Media Bayer's low-dose MRI contrast agent gadoquatrane approved in U.S. Gadoquatrane from Bayer receives FDA approval for contrast-enhanced MRI to detect and visualize lesions with abnormal vascularity in the central nervous system and non-CNS body regions / Gadoquatrane becomes the lowest-dose macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) approved in the U.S., with a recommended dose of 0.01 mmol/kg actual body weight, corresponding to 0.04 mmol Gd/kg body weight / Approval is supported by data from the Phase III QUANTI clinical studies, which demonstrated efficacy at a fraction of the dose compared to mGBCAs dosed at 0.1 mmol Gd/kg body weight / Gadoquatrane received its first approval in Japan in March 2026, further submissions to health authorities worldwide are ongoing to secure marketing authorization in additional markets Berlin, June 15, 2026 - Bayer today announced that the U.S. Food and Drug Administration (FDA) approved gadoquatrane, a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) under the brand name Ambelvist™. The product is 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. Gadoquatrane is a next-generation mGBCA with a novel tetrameric structure and high relaxivity (a measure of signal enhancement). With this approval, gadoquatrane becomes the lowest dose mGBCA in the U.S. It has a recommended dose of 0.01 mmol/kg actual body weight (which corresponds to 0.04 mmol Gd/kg body weight), representing 60% less Gd compared to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight and 20% less Gd compared to gadopiclenol dosed at 0.05 mmol Gd/kg body weight. There is a rising need for medical imaging, driven by the increasing incidence of chronic diseases such as cancer and cardiovascular diseases. Contrast-enhanced MRI is a medical imaging examination often used by clinicians to gain insight into what's happening in the human body and can play an important role in detecting abnormalities, monitoring disease progression and informing treatment decisions. For some adults and children with chronic dise...