India Pharma Outlook Team | Thursday, 28 August 2025
Bayer has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for gadoquatrane, an investigational macrocyclic gadolinium-based contrast agent (GBCA) intended for contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system (CNS) and other areas of the body in both adults and children, as well as newborns.
If approved, gadoquatrane would be the lowest-dose macrocyclic GBCA on the market in the U.S., with a submitted dose of 0.04 mmol gadolinium per kilogram of body weight, representing a 60% dose decrease over existing macrocyclic GBCAs that are generally dosed at 0.1 mmol/kg. Reduced dosing will likely be beneficial to patients who need to undergo repeated MRI scans, for example, those with cancer, multiple sclerosis, and cardiovascular disease.
Dr. Konstanze Diefenbach, Radiology Research & Development Head for Bayer's Pharmaceuticals Division, added that increasing rates of chronic disease are fueling demand for medical imaging, thus reduced contrast agent exposure is a compelling development.
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NDA filing is preceded by encouraging outcomes from critical Phase III QUANTI trials, which tested gadoquatrane's efficacy and safety in various patient populations worldwide. Outside of the U.S., reviews are underway in Japan, the European Union, and several other territories, with further applications scheduled for this year.
Since 1988, there have been over 800 million doses of GBCA used globally, including a projected 63 million in 2023 alone. At the rate of 12–18 million contrast-enhanced MRI scans a year in the U.S., approval of gadoquatrane could have a large impact on diagnostic imaging patterns.
MRI is still a non-invasive, radiation-free imaging method essential for diagnosing and tracking disease. Bayer's gadoquatrane, with its stable tetrameric structure and elevated relaxivity, seeks to enhance precision imaging while lowering the exposure of patients to gadolinium globally.
