Bayer has announced the submission of a marketing authorization application to the European Medicines Agency (EMA) for gadoquatrane, an investigational contrast agent designed to enhance magnetic resonance imaging (MRI) in both adult and pediatric patients—including neonates. The agent is intended for the detection and visualization of known or suspected pathologies across all body regions and the central nervous system (CNS).
The proposed dose of 0.04 mmol gadolinium per kilogram represents a 60% reduction in gadolinium exposure compared to current standard-of-care macrocyclic contrast agents, typically administered at 0.1 mmol/kg. If approved, gadoquatrane would become the lowest-dose macrocyclic gadolinium-based contrast agent (GBCA) available in the European Union.
“With this submission, we aim to offer physicians and patients in the EU a safer, low-dose option for contrast-enhanced MRI,” said Dr. Konstanze Diefenbach, Head of Radiology R&D at Bayer. “Our goal aligns with international guidance advocating for the lowest effective dose, particularly for patients requiring repeated imaging over their lifetimes due to chronic conditions.”
Each year, approximately 16 million contrast-enhanced MRI scans are performed across the EU, with demand growing at 5% annually. Bayer’s application is supported by strong data from the Phase III QUANTI trials, which demonstrated the efficacy and safety of gadoquatrane across diverse clinical settings in both adults and children.
The EMA submission follows recent applications filed in Japan and the United States, marking gadoquatrane’s first global regulatory milestones. Bayer plans to submit further applications to health authorities in additional regions in the near future.