Bayer Files for Approval of Gadoquatrane MRI Contrast Agent in Japan

Bayer Files for Approval of Gadoquatrane MRI Contrast Agent in Japan

German pharmaceutical giant Bayer AG (ETR: BAYN) this week filed a marketing application with Japan’s Ministry of Health, Labour, and Welfare (MHLW) for its investigational contrast agent gadoquatrane. The agent is designed for use in magnetic resonance imaging (MRI) to detect and visualize known or suspected pathologies in all body regions and the central nervous system (CNS) in adults and pediatric patients, including neonates.

Innovative Contrast Agent
Gadoquatrane is a novel tetravalent macrocyclic gadolinium contrast agent. It is designed to achieve high-contrast MRI imaging while significantly reducing the required gadolinium dose per injection by 60%, thereby lowering gadolinium burden while maintaining image quality. This filing marks the first marketing application for gadoquatrane and is supported by positive results from the global Phase III QUANTI study.

Market Potential in Japan
Japan has the highest number of MRI scanners per capita worldwide, performing approximately 20 million procedures annually, according to Bayer. The submission to the MHLW highlights Bayer’s commitment to advancing imaging solutions and addressing the significant demand for innovative contrast agents in Japan’s healthcare market.-Fineline Info & Tech