FDA Approves Gadoquatrane to Detect CNS and Non-CNS Body Region Lesions

The FDA has approved gadoquatrane (Ambelvist) for contrast-enhanced MRI to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates, according to a news release from the developer, Bayer.¹ With this approval, gadoquatrane becomes the lowest-dose macrocyclic gadolinium-based contrast agent (mGBCA) available in the US, featuring a next-generation tetrameric structure and high relaxivity.

The approved indications include:

• The central nervous system: brain, spine, and associated tissues
• The body: head and neck, thorax, abdomen, pelvis, and musculoskeletal system

What is gadoquatrane? How does it compare with other macrocyclic contrast agents?

Gadoquatrane is a novel intravenous mGBCA designed to achieve high-quality MRI enhancement at a substantially reduced gadolinium dose. The recommended dose is 0.01 mmol/kg actual body weight, delivering 0.04 mmol Gd/kg. This represents 60% less gadolinium than mGBCAs dosed at 0.1 mmol Gd/kg body weight and 20% less gadolinium than gadopiclenol, which delivers 0.05 mmol Gd/kg body weight.

Bayer has maintained a long presence in GBCA development, having brought the first such agent to market in 1988. American College of Radiology guidance encourages providers to use the lowest gadolinium dose sufficient to obtain adequate imaging.

“As a lower-gadolinium-dose GBCA, [gadoquatrane] supports healthcare providers in adhering to growing clinical guidance to utilize the lowest gadolinium dose necessary to adequately image patients,” said Jill Carbone, vice president and head of radiology, North America Product and Pipeline, Bayer, in the press release.¹

What did the Phase 3 QUANTI clinical studies demonstrate?

The FDA approval is supported by data from the global pivotal phase 3 QUANTI program, which evaluated the efficacy and safety of gadoquatrane in adult and pediatric patients, including term neonates, undergoing contrast-enhanced MRI.²

Combined pre- and post-contrast MRI sets using the reduced gadolinium dose in gadoquatrane produced increased lesion visualization compared with pre-contrast MRI images alone. In descriptive analyses, visualization scores and lesion counts per blinded independent reader for gadoquatrane were comparable to those achieved with mGBCAs administered 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,” added Christopher Hancock, MD, director of neuroradiology at HALO Diagnostics Desert Cities and an investigator for the QUANTI clinical studies, in the press release.¹

The safety and effectiveness of gadoquatrane in the CNS and body have been established in pediatric patients, including term neonates. Pediatric support was derived from adequate and well-controlled adult studies and is supplemented by pharmacokinetic and safety data from 93 patients aged 28 days to younger than 18 years who received a single 0.01 mmol/kg dose of gadoquatrane and underwent MRI of any body region.

What are the key safety considerations for gadoquatrane?

Gadoquatrane carries a Boxed Warning for risks associated with intrathecal administration, which can cause serious adverse reactions including death, coma, encephalopathy, and seizures, as the agent is not approved for intrathecal use. A Boxed Warning also applies for nephrogenic systemic fibrosis, the risk for which is highest in patients with chronic, severe kidney disease or acute kidney injury, and use should be avoided in these patients unless diagnostic information cannot be obtained through non-contrasted MRI or other modalities.

Gadoquatrane is contraindicated in patients with a history of severe hypersensitivity reactions to the agent. Additional warnings and precautions include gadolinium retention, acute kidney injury, and potential interference with lesion visualization. The most frequently reported adverse reactions were dizziness, headache, injection site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus.

References

1. Bayer's AMBELVIST® (gadoquatrane) receives FDA approval for contrast-enhanced MRI to detect and visualize lesions with abnormal vascularity in the central nervous system and non-CNS body regions. News release. Bayer Corporation. June 15, 2026. Accessed June 15, 2026. https://tinyurl.com/457myjcx
2. Prescribing information. AMBELVIST (gadoquatrane). FDA. Accessed June 15, 2026. https://tinyurl.com/hmp582cw