By Kelly Cloonan

Bayer submitted a new drug application for approval of its contrast agent gadoquatrane to the Food and Drug Administration.

The German life-sciences company said Tuesday the agent provides contrast-enhanced magnetic resonance imaging of the central nervous system and other body regions in adults and pediatric patients, including newborns.

The company's application included a submitted dose of 0.04 millimole gadolinium per kilogram of body weight. If approved, gadoquatrane would become the lowest dose macrocyclic gadolinium-based contrast agent available in the U.S., Bayer said.

The submission is based on positive data from Phase III studies evaluating the efficacy and safety of gadoquatrane in adult and pediatric patients, the company said.

Patients, especially those with chronic conditions who require multiple contrast-enhanced MRI examinations during their lifetime, can benefit from a reduced gadolinium dose, according to Dr. Konstanze Diefenbach, Bayer's head of radiology research and development.

"There is a rising need for medical imaging, among others driven by the increasing incidence of chronic diseases such as cancer and cardiovascular diseases," Diefenbach said. Almost 40 million MRI scans are conducted in the U.S. annually.

Bayer also recently submitted gadoquatrane for approval in Japan. The company plans to submit further regulatory applications to health authorities worldwide in the coming months, it said.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

June 17, 2025 11:49 ET (15:49 GMT)

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