Bayer Announces Positive Phase III Data Supporting Efficacy and Safety of Gadoquatrane, a Novel Low-Dose High-Relaxivity MRI Contrast Agent

● The research data released in this study are based on analyses of abdominal and central nervous system (CNS) magnetic resonance imaging (MRI), magnetic resonance angiography (MRA), and pharmacokinetics.

● In the Phase III clinical trial QUANTI, gadoquatrane was administered at a dose of 0.04 mmol Gd/kg body weight, representing a 60% reduction in gadolinium dose compared with macrocyclic gadolinium-based contrast agents (GBCAs) at the conventional dose of 0.1 mmol Gd/kg body weight.

● Marketing applications for gadoquatrane have been submitted to health regulatory authorities in multiple countries worldwide, including China, covering multiple indications and age groups. If approved, gadoquatrane will become the novel gadolinium-based contrast agent with the highest relaxivity and the lowest gadolinium dose on the Chinese market.

Bayer, a global leader in radiology, recently announced additional positive Phase III clinical trial data for gadoquatrane, an investigational high-relaxivity, low-dose gadolinium-based MRI contrast agent. The findings, derived from multiple subgroups and integrating clinical data with pharmacokinetic analyses, further support the efficacy and safety of this contrast agent. These data originate from the gadoquatrane clinical research program, including the pivotal Phase III QUANTI study, which evaluated gadoquatrane at a dose of 0.04 mmol Gd/kg body weight. The results were presented at the European Congress of Radiology (ECR), held in Vienna, Austria, from March 4 to 8, 2026, with a focus on abdominal and central nervous system magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA).

The study results confirmed that, in clinical settings, the diagnostic efficacy of Gadoquatrane is non-inferior to that of macrocyclic gadolinium-based contrast agents (GBCAs) at the conventional dose of 0.1 mmol Gd/kg body weight, while reducing the gadolinium dose by 60%. Pharmacokinetic analyses indicated that the diagnostic efficacy of Gadoquatrane observed in adults is also applicable to pediatric patients. Additional results from the Phase III studies of Gadoquatrane (all of which met both primary and secondary endpoints) will be presented at future conferences.

Based on positive data from the clinical development program, including subgroup analyses, Bayer has submitted marketing authorization applications for Gadoquatrane in multiple global markets, including China, Japan, the United States, and the European Union. The application has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). Additional submissions to other markets are expected in the coming months. If approved, Gadoquatrane will become the novel gadolinium-based contrast agent with the highest relaxivity and the lowest gadolinium dose available on the Chinese market.

The marketing authorization application for gadoquatrane in China is based on the positive data from the global pivotal Phase III clinical trial program, QUANTI. This study included Chinese patients, enrolled 14 investigative sites in China, and evaluated the efficacy and safety across a broad range of indications in adult and pediatric patients of all ages.

Dr. Benjamin P. Liu, Associate Professor of Radiology and Radiation Oncology at Northwestern University’s Feinberg School of Medicine in Chicago, stated: “With advances in medicine and science, contrast-enhanced MRI plays a crucial role in diagnosis and treatment. Given that health agencies and medical associations recommend using the lowest possible gadolinium dose, there is growing demand for low-dose MRI contrast agents. Low-dose regimens both reduce patients’ lifetime gadolinium exposure and preserve the diagnostic information required by clinicians.”

Dr. Konstanze Diefenbach, Head of R&D at Bayer Diagnostic Imaging, stated: “Subgroup analysis data demonstrate that Gadoquatrane delivers consistent diagnostic performance in central nervous system, vascular, and abdominal imaging, even with a significantly reduced gadolinium dose—a benefit particularly important for patients requiring multiple MRI examinations. These data support the broad clinical application potential of Gadoquatrane, and we are committed to making this new option available to as many patients and their physicians as possible.”

The pivotal QUANTI clinical development program for gadoquatrane comprises two international, multicenter, prospective, randomized, double-blind, crossover Phase III clinical studies—QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions)—as well as the QUANTI Pediatric Study in children. Results from all QUANTI studies demonstrated that gadoquatrane, while reducing the gadolinium dose by 60%, met both primary and secondary efficacy endpoints for assessment of visualization parameters and lesion detection, compared with macrocyclic gadolinium-based contrast agents administered at a dose of 0.1 mmol Gd/kg body weight.

A total of 808 patients from 15 countries participated in the study. Among them, 161 patients with known or suspected lesions (primarily involving the liver, pancreas, and kidneys) were included in the abdominal subgroup analysis. In the MRA subgroup analysis, 34 patients from two Phase III studies were enrolled; these patients primarily presented with conditions such as vascular stenosis, plaques, and hypertension. Both analyses employed blinded independent central review for image assessment, and the results demonstrated that Gadoquatrane had comparable visualization scores to the macrocyclic gadolinium-based contrast agent used as the control. Across all Phase III subgroup analyses, the overall safety profile of Gadoquatrane was similar to that of the control macrocyclic gadolinium-based contrast agent. No new safety signals were observed.

An integrated Phase II/III CNS study analysis presented at the ECR, which included 362 adult subjects, explored the potential impact of Gadoquatrane’s structure on diagnostic efficacy and pharmacokinetics. The results demonstrated that the diagnostic efficacy of Gadoquatrane was non-inferior to that of the control macrocyclic gadolinium-based contrast agent, and its larger tetrameric structure had no significant effect on its pharmacokinetics. Further confirmation was provided by an analysis of data from the entire clinical development program, including pediatric studies, using a population pharmacokinetic (popPK) model. This analysis showed that Gadoquatrane exhibits similar pharmacokinetic profiles in both pediatric and adult populations, thereby supporting regulatory submissions for different indications and age groups.

Gadoquatrane is a novel low-dose extracellular gadolinium-based contrast agent developed by Bayer. Featuring a unique tetrameric structure with a macrocyclic core, it offers high stability and high relaxivity. The recently published Phase III clinical study evaluated its efficacy in contrast-enhanced MRI.

MRI is a non-invasive, radiation-free imaging modality that provides detailed images of the human body, facilitating the identification and differentiation of potential abnormal lesions in organs and tissues, thereby supporting clinicians in addressing critical medical questions related to disease detection, characterization, and monitoring. It is estimated that over 60 million doses of macrocyclic gadolinium-based contrast agents will be used worldwide in 2024. Since 1988, more than 900 million doses of macrocyclic gadolinium-based contrast agents have been administered globally.