FDA Approves Low-Dose MRI Contrast Agent Gadoquatrane

The Food and Drug Administration (FDA) has approved gadoquatrane, a macrocyclic gadolinium (Gd)-based contrast agent (mGBCA), for MRI detection and visualization of abnormal vascularity in the central nervous system (CNS) and non-CNS body regions.

Recommended dosing for gadoquatrane, which will be marketed as Ambelvist, is 0.01 mmol/kg actual body weight (delivering 0.04 mmol Gd/kg body weight), according to Bayer Pharmaceuticals, the manufacturer of gadoquatrane. The company noted that gadoquatrane can be delivered with 60 percent less gadolinium exposure in comparison to other mGBCAs and 20 percent less gadolinium than gadopiclenol.

Bayer said gadoquatrane, which offers a novel tetrameric structure and high relaxivity, is indicated for adults and pediatric patients (including term neonates).

The FDA approval of gadoquatrane was supported by data from the QUANTI phase 3 prospective multicenter randomizedtrials — involving over 800 patients from 15 countries — that revealed the agent’s efficacy at the aforementioned reduced gadolinium dosing in contrast to mGBCAs dosed at 0.1 mmol Gd/kg body weight.

“I often rely on contrast-enhanced MRI exams to inform clinical decision making. With this approval, we now have an additional option that can help deliver contrast-enhanced images at the lowest macrocyclic GBCA dose, reducing gadolinium exposure while preserving the clinical information we often need,” noted Christopher Hancock, MD, MBA, the director of neuroradiology at HALO Diagnostics Desert Cities and an investigator for the QUANTI clinical studies.

In an interview with Diagnostic Imaging at the 2025 RSNA conference, Talissa Altes, MD, discussed the potential merit of gadoquatrane for serial MRI monitoring in pediatric patients.

“For me, having 60 percent less gadolinium exposure to the patient in a very stable agent seems like a large advantage, particularly for those children that require multiple MRs in their lifetimes,” noted Dr. Altes, a professor and chair of radiology at the University of Missouri.