by
Gus Iversen, Editor in Chief | June 26, 2025
Bayer has filed a New Drug Application with the FDA seeking approval for gadoquatrane, an investigational gadolinium-based contrast agent (GBCA) intended for MR of the central nervous system and other regions in adults and pediatric patients, including term neonates.
The Whippany, New Jersey-based pharmaceutical division submitted the agent at a dosage of 0.04 mmol of gadolinium per kilogram of body weight. If approved, this would represent a 60% reduction in gadolinium dose compared to currently approved macrocyclic GBCAs administered at 0.1 mmol/kg, positioning gadoquatrane as the lowest-dose option in its class in the U.S. market.
The FDA submission is backed by results from the global Phase III QUANTI development program, which evaluated gadoquatrane across more than 800 patients in 15 countries. The QUANTI program includes three randomized, double-blind studies: one focusing on central nervous system imaging, another on other body regions, and a pediatric study.
Ad Statistics
Times Displayed: 134286
Times Visited: 7699 MIT labs, experts in Multi-Vendor component level repair of: MRI Coils, RF amplifiers, Gradient Amplifiers Contrast Media Injectors. System repairs, sub-assembly repairs, component level repairs, refurbish/calibrate. info@mitlabsusa.com/+1 (305) 470-8013
According to Bayer, gadoquatrane met its primary and secondary endpoints in these trials, with efficacy measured through lesion visualization and detection. The pediatric data showed similar pharmacokinetics to adult use, and the overall safety profile was consistent with existing macrocyclic agents, with no new safety concerns identified.
“Patients can benefit from a dose reduction, especially patients with chronic conditions who require multiple contrast-enhanced MR examinations during their lifetime,” said Dr. Konstanze Diefenbach, head of radiology research and development at Bayer. “This is in line with guidance from health authorities and guidelines from scientific bodies, which recommend using the lowest dose required to obtain the needed clinical information.”
The company recently filed for regulatory approval in Japan and indicated plans to pursue additional submissions in other regions.
Gadoquatrane is a macrocyclic extracellular GBCA with a tetrameric structure designed for high relaxivity and stability. Contrast-enhanced MRI is widely used for diagnostic imaging, with an estimated 40 million procedures performed annually in the U.S.
