FDA Clears Bayer’s Ambelvist (Gadoquatrane) for MRI in Adults and Children, Including Term Neonates

The U.S. Food and Drug Administration has approved Bayer’s Ambelvist (gadoquatrane), a next-generation macrocyclic gadolinium-based contrast agent (mGBCA), for use in magnetic resonance imaging (MRI) in adults and paediatric patients, including term neonates.

What Ambelvist Is

Ambelvist features a novel tetrameric molecular structure and is designed to provide high relaxivity, which enhances MRI signal at lower administered doses compared with some existing agents.

Indications and Dosing

The agent is indicated to help detect and visualise lesions with abnormal vascularity across both the central nervous system (CNS) and non-CNS regions. In the United States, Ambelvist will be marketed as the lowest-dose mGBCA, with a recommended administration of 0.01 mmol per kilogram of actual body weight, which corresponds to delivering 0.04 mmol of gadolinium (Gd) per kilogram.

Clinical Evidence

FDA approval was supported by data from global Phase III QUANTI studies that evaluated safety and efficacy in adults and children, including term neonates. The trials showed that combining pre-contrast and post-contrast MRI using Ambelvist at the reduced gadolinium dose improved lesion visualisation compared with pre-contrast MRI alone. At the recommended dose, the number of lesions detected and visualisation scores were comparable to those observed with other tested macrocyclic GBCAs administered at higher gadolinium doses.

Pediatric evaluation drew on adult trial results plus pharmacokinetic and safety data from 93 children aged 28 days to under 18 years, supporting use in this population, including term neonates.

“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,” said Jill Carbone, Vice President of Product and Pipeline and Head of Radiology, Bayer North America. “As a lower‑gadolinium‑dose GBCA, Ambelvist supports clinicians in adhering to guidance to use the lowest gadolinium dose necessary for diagnostic imaging.”

Regulatory Note

Separately, in March 2026 the FDA granted expanded clearance for Bayer’s Medrad MRXperion magnetic resonance injection system, broadening the range of MRI scanners compatible with that device.

Source and Disclaimer: This report is based on announcements and trial summaries provided by Bayer and regulatory filings. It is intended for informational purposes and does not substitute for professional medical advice. Clinicians should consult full prescribing information and local guidance when selecting contrast agents.