The US Food and Drug Administration (FDA) has approved Bayer’s Ambelvist (gadoquatrane), a macrocyclic gadolinium-based contrast agent (mGBCA), for use in magnetic resonance imaging (MRI) in adults and children, including term neonates.
The agent is indicated for identifying and visualising lesions with abnormal vascularity in both the central nervous system (CNS) and non-CNS body regions.
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Ambelvist has a new tetrameric structure and high relaxivity.
In the US, it will be available as the lowest-dose mGBCA, with a recommended amount of 0.01mmol per kilogram of actual body weight, delivering 0.04mmol gadolinium per kilogram.
The approval is based on results from global Phase III QUANTI studies, which examined the safety and efficacy of Ambelvist in both adults and children, including term neonates.
In these trials, increased lesion visualisation was observed with the combination of pre-contrast and post-contrast MRI at a reduced gadolinium dose, compared to pre-contrast MRI alone.
The number of lesions identified and visualisation scores for Ambelvist at the recommended dose were similar to those observed with other tested mGBCAs at higher gadolinium doses.
Evaluation in paediatric patients, including term neonates, is supported by trials in adults as well as pharmacokinetic and safety data from 93 children aged 28 days to under 18 years.
Bayer North America product and pipeline vice-president and radiology head Jill Carbone said: “At Bayer, our focus has always been on enhancing patient care, and we are proud to introduce Ambelvist as our next-generation option for contrast-enhanced MRI.
“As a lower-gadolinium-dose GBCA, Ambelvist supports healthcare providers in adhering to growing clinical guidance to utilise the lowest gadolinium dose necessary to adequately image patients.”
In March 2026, the FDA granted expanded clearance to Bayer’s Medrad MRXperion, broadening the magnetic resonance injection system’s application across a wider range of MRI scanners.
