Bayer has announced that the US Food and Drug Administration (FDA) has approved gadoquatrane, a new intravenous macrocyclic Gadolinium-Based Contrast Agent (mGBCA), under the brand name Ambelvist. The approval marks a significant advancement in Magnetic Resonance Imaging (MRI) diagnostics by introducing the lowest-dose macrocyclic gadolinium contrast agent currently available in the United States.

Ambelvist is indicated for use in contrast-enhanced MRI to detect and visualise lesions with abnormal vascularity in both Central Nervous System (CNS) and non-CNS body regions. The approval covers adult and pediatric patients, including term neonates.

Gadoquatrane is a next-generation mGBCA featuring a novel tetrameric structure and high relaxivity, a property that enhances MRI signal quality and image clarity. Its low-dose formulation enables effective imaging while reducing patient exposure to gadolinium.

The approved recommended dose of Ambelvist is 0.01 mmol/kg of actual body weight, corresponding to 0.04 mmol Gd/kg body weight. This represents a 60 percent reduction in gadolinium exposure compared with conventional macrocyclic contrast agents containing 0.1 mmol Gd/kg body weight, and a 20 percent reduction compared with gadopiclenol administered at 0.05 mmol Gd/kg body weight.

The demand for medical imaging continues to rise globally, driven by the increasing prevalence of chronic diseases such as cancer and cardiovascular disorders. Contrast-enhanced MRI plays a critical role in detecting abnormalities, monitoring disease progression and guiding treatment decisions. Patients with chronic conditions such as multiple sclerosis, neurological disorders and various cancers often require repeated MRI examinations over time, making reductions in lifetime gadolinium exposure increasingly important.

Dr. Christopher Hancock, Director of Neuroradiology at HALO Diagnostics Desert Cities in the United States and an investigator in the QUANTI clinical studies, noted that contrast-enhanced MRI is a key tool in clinical decision-making. He said the approval provides physicians with an additional option that delivers diagnostic-quality images while minimising gadolinium exposure.

Bayer highlighted that reducing lifetime gadolinium exposure aligns with evolving clinical guidance recommending the use of the lowest contrast dose necessary to achieve adequate imaging results.

Dr. Konstanze Diefenbach, Head of Radiology Research and Development at Bayer’s Pharmaceuticals Division, stated that the approval reinforces Bayer’s longstanding leadership in radiology and MRI contrast agents. The company launched the world’s first gadolinium-based contrast agent in 1988 and continues to advance innovations in diagnostic imaging.

The FDA approval is based on findings from the global pivotal Phase 3 QUANTI clinical studies, which evaluated the efficacy and safety of gadoquatrane in adult and pediatric patients, including term neonates undergoing contrast-enhanced MRI.

Results from the studies demonstrated improved lesion visualisation when pre-contrast and post-contrast MRI images were combined, despite the lower gadolinium dose. Lesion detection rates and image quality scores achieved with gadoquatrane at 0.01 mmol/kg were comparable to those of conventional macrocyclic contrast agents administered at higher doses.

The pediatric approval is supported by data from controlled adult studies as well as dedicated pharmacokinetic and safety findings from a pediatric trial involving 93 patients aged 28 days to under 18 years who received a single dose and underwent MRI examinations across different body regions.

Gadoquatrane received its first regulatory approval in Japan in March 2026. Bayer has also submitted marketing applications in other regions, including the European Union and China, with additional filings planned globally.

The approval of Ambelvist underscores ongoing efforts within radiology to enhance diagnostic performance while improving patient safety through lower-dose imaging solutions.