FDA approves gadoquatrane for contrast-enhanced MRI at lowest macrocyclic gadolinium dose available in the US

The FDA has granted approval to gadoquatrane (Ambelvist, Bayer), a novel intravenous macrocyclic gadolinium-based contrast agent (mGBCA), for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions. The approval, announced June 15, 2026, covers adult and pediatric patients, including term neonates.¹

With a recommended dose of 0.01 mmol/kg actual body weight, delivering 0.04 mmol gadolinium (Gd)/kg body weight, gadoquatrane is now the lowest-dose mGBCA approved in the United States, providing 60% less gadolinium compared with macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight and 20% less than gadopiclenol at 0.05 mmol Gd/kg.¹

"I often rely on contrast-enhanced MRI exams to inform clinical decision making," said Christopher Hancock, MD, MBA, director of Neuroradiology at HALO Diagnostics Desert Cities and an investigator in the QUANTI clinical studies. "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."¹

QUANTI phase 3 program: trial design and efficacy of gadoquatrane in CNS and whole-body MRI

The FDA approval rests on data from the global pivotal phase 3 QUANTI program, a multinational clinical development initiative comprising three studies: QUANTI CNS (central nervous system, adults), QUANTI OBR (other body regions, adults), and QUANTI Pediatric (pharmacokinetics and safety in patients from birth to under 18 years).²

In QUANTI CNS, which enrolled 305 patients across 16 countries in Europe, Asia, and the Americas, gadoquatrane met the primary endpoints of non-inferiority to comparator mGBCAs (gadobutrol, gadoterate meglumine, gadoteridol) across three established visualization parameters: contrast enhancement, delineation, and morphology, all assessed by blinded independent readers.² Gadoquatrane also demonstrated non-inferior sensitivity and specificity for lesion detection and exclusion, and showed superiority over unenhanced MRI across the same visualization endpoints.²

In the pediatric cohort, the pharmacokinetic behavior of gadoquatrane was similar to that observed in adults. Safety data were collected from 93 pediatric patients aged 28 days to under 18 years who received a single 0.01 mmol/kg dose across all body regions. No new safety signals were identified in either adults or children across the QUANTI program.¹

The most common adverse reactions reported at an incidence of 0.2% or greater were dizziness, headache, injection site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus.¹

Disease burden and clinical rationale for a lower-dose gadolinium contrast agent

Contrast-enhanced MRI is a widely used diagnostic tool for detecting abnormalities, evaluating disease progression, and informing treatment decisions across oncology, neurology, cardiology, and other specialties.¹ For patients with chronic diseases, including multiple sclerosis, spinal cord pathology, and cancer, serial imaging may be required at regular intervals over months or years, resulting in cumulative gadolinium exposure.

Gadolinium retention in tissues—particularly brain, bone, and skin—has been a recognized concern with GBCAs since the mid-2010s. Macrocyclic agents are associated with less retention than linear GBCAs, but clinical guidance increasingly favors using the minimum effective dose.⁴ The American College of Radiology (ACR) manual on contrast media recommends that clinicians utilize the lowest gadolinium dose necessary to achieve adequate imaging.⁴

Gadoquatrane mechanism of action, novel tetrameric structure, and Bayer's GBCA history

Gadoquatrane is a macrocyclic mGBCA with a novel tetrameric molecular structure that confers high relaxivity, a measure of signal enhancement efficiency per unit of gadolinium, enabling effective tissue visualization at substantially reduced absolute gadolinium doses.¹

The macrocyclic architecture of gadoquatrane contributes to thermodynamic and kinetic stability of the Gd chelate complex, a property associated with lower rates of gadolinium dissociation and tissue deposition compared with linear GBCAs. Bayer has been active in GBCA development since 1988, when the company launched the first FDA-approved gadolinium contrast agent; gadoquatrane represents its next-generation entry in the class.¹

Expert perspective on gadoquatrane's clinical role

The non-inferiority design of the QUANTI studies is worth noting in clinical interpretation: the trials were powered to demonstrate that gadoquatrane is not worse than established mGBCAs at standard doses, not that it is superior. Head-to-head superiority over other low-dose agents has not been directly demonstrated in this program, and the comparisons to gadopiclenol (20% less gadolinium) and standard-dose mGBCAs (60% less gadolinium) are based on dose arithmetic rather than head-to-head superiority studies.

For radiologists managing patients requiring longitudinal imaging, the availability of a lower-dose mGBCA that preserves diagnostic accuracy provides a clinically meaningful option, particularly in pediatric populations where minimizing long-term gadolinium accumulation is an ongoing consideration.

Limitations and safety considerations for gadoquatrane

Gadoquatrane carries a Boxed Warning for 2 risks: adverse reactions associated with intrathecal administration (the agent is not approved for intrathecal use) and nephrogenic systemic fibrosis (NSF) in patients with severely impaired renal elimination. Clinicians should screen patients for acute kidney injury and estimate glomerular filtration rate in those at risk for chronic renal impairment (age >60 years, hypertension, or diabetes) before administration.¹

The label also includes Warnings and Precautions for hypersensitivity reactions, gadolinium retention, acute kidney injury at above-recommended doses, and potential interference with lesion visualization on non-contrast sequences. The agent is contraindicated in patients with a history of severe hypersensitivity to gadoquatrane.¹

Long-term data on gadolinium retention specific to gadoquatrane's tetrameric structure, and comparative retention data versus gadopiclenol, have not been fully characterized in published literature, representing an area for postmarketing evaluation.

References

1. Bayer Pharmaceuticals. AMBELVIST (gadoquatrane) [package insert]. U.S. Food and Drug Administration. June 2026. Accessed June 15, 2026. https://labeling.bayerhealthcare.com/html/products/pi/ambelvist_PI.pdf

2. Bayer AG. Positive results from Phase III study for Bayer's investigational contrast agent gadoquatrane. February 26, 2025. Accessed June 15, 2026. https://www.bayer.com/media/en-us/positive-results-from-phase-iii-study-for-bayers-investigational-contrast-agent-gadoquatrane/

3. National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. Magnetic resonance imaging (MRI). Accessed June 15, 2026. https://www.nibib.nih.gov/science-education/science-topics/magnetic-resonance-imaging-mri

4. American College of Radiology. ACR manual on contrast media. 2026. Accessed June 15, 2026. https://www.acr.org/clinical-resources/clinical-tools-and-reference/contrast-manual