Bayer announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational contrast agent, gadoquatrane. The agent is intended for use in contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system (CNS) and other body regions in adults and pediatric patients, including term neonates. The submitted dose is 0.04 mmol gadolinium (Gd) per kilogram of body weight. If approved, gadoquatrane would be the lowest-dose macrocyclic gadolinium-based contrast agent (GBCA) available in the U.S., representing a 60% reduction compared to currently approved macrocyclic GBCAs, which are typically dosed at 0.1 mmol Gd/kg.
The NDA submission is supported by positive data from Bayer’s Phase III QUANTI clinical development program, which assessed the efficacy and safety of gadoquatrane in adult and pediatric patients globally. Preliminary results from the QUANTI CNS study were presented earlier this year at the European Congress of Radiology (ECR), with additional data expected at upcoming scientific conferences.
Each year, nearly 40 million MRI scans are performed in the United States, with increasing demand driven largely by the rising prevalence of chronic diseases such as cancer and cardiovascular conditions. “There is a growing need for medical imaging as part of disease diagnosis and monitoring,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer. “We remain committed to innovating in radiology, including developing lower-dose options that may reduce cumulative gadolinium exposure. This is especially important for patients with chronic illnesses who may require multiple contrast-enhanced MRI scans over their lifetime.”
Bayer also recently submitted a marketing application for gadoquatrane to Japan’s Ministry of Health, Labour, and Welfare (MHLW), marking its first regulatory filing for this agent. Additional regulatory submissions to health authorities in other countries are planned in the coming months.
The QUANTI Phase III program evaluated gadoquatrane at 0.04 mmol Gd/kg body weight across three key studies: QUANTI CNS (central nervous system), QUANTI OBR (other body regions), and QUANTI Pediatric. In total, 808 patients from 15 countries participated in these randomized, double-blind, crossover studies. The studies met their primary and secondary efficacy endpoints, demonstrating that gadoquatrane provided effective visualization and lesion detection with a significantly lower gadolinium dose.
The QUANTI Pediatric study further showed that gadoquatrane's pharmacokinetics in children were comparable to those observed in adults. Across all studies, the safety profile of gadoquatrane in both adults and pediatric patients (including newborns) was consistent with previously reported data for macrocyclic GBCAs. No new safety concerns or signals were identified during the trials.