Pharmaceuticals

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

United States of America

Key Facts:

  • Bayer’s AMBELVIST® (gadoquatrane) becomes the lowest-dose macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) approved in the U.S., with a recommended dose of 0.01 mmol/kg actual body weight delivering 0.04 mmol Gd/kg body weight  

  • Approval is supported by data from the Phase III QUANTI clinical studies, which demonstrated efficacy at a fraction of the dose compared to mGBCAs dosed at 0.1 mmol Gd/kg body weight1

WHIPPANY, N.J. – JUNE 15, 2026 – Bayer today announced that the U.S. Food and Drug Administration (FDA) approved AMBELVIST® (gadoquatrane), a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) indicated 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 in adult and pediatric patients, including term neonates.1 AMBELVIST is a next-generation mGBCA with a novel tetrameric structure and high relaxivity (a measure of signal enhancement).1

 

With this approval, AMBELVIST becomes the lowest-dose mGBCA in the U.S. AMBELVIST has a recommended dose of 0.01 mmol/kg actual body weight (which delivers 0.04 mmol Gd/kg body weight), representing 60% less Gd compared to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight and 20% less Gd compared to gadopiclenol with a Gd content of 0.05 mmol Gd/kg body weight.1,2

 

WHY THIS APPROVAL MATTERS:

 

Contrast-enhanced MRI is a medical imaging examination often used by clinicians to gain insight into what’s happening in the human body. This type of study can play an important role in detecting abnormalities, monitoring disease progression and informing treatment decisions.3 For some adults and children with chronic diseases or conditions that require close, long-term monitoring—such as multiple sclerosis, other neurological or spinal conditions as well as different types of cancer—regular, serial images may be required. 

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.
Dr. Christopher Hancock
,
Director of Neuroradiology at HALO Diagnostics Desert Cities and an investigator for the QUANTI clinical studies

KEY CLINICAL TRIAL FINDINGS: 
The FDA approval is based on the global pivotal Phase III QUANTI clinical studies, which evaluated the efficacy and safety of AMBELVIST in adult and pediatric patients, including term neonates, undergoing contrast-enhanced MRI.1 Key findings demonstrated: 

  • Increased lesion visualization with the combined pre-contrast and post-contrast MRI sets with the decreased Gd dose in AMBELVIST compared with only pre-contrast MRI images.1
  • Visualization scores and number of lesions identified per blinded independent reader for AMBELVIST dosed at 0.01 mmol/kg body weight (which delivers 0.04 mmol Gd/kg body weight) were similar to other tested mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight in descriptive analyses.1
  • The safety and effectiveness of AMBELVIST for use with MRI to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system) have been established in pediatric patients, including term neonates. Use of AMBELVIST in this age group is supported by evidence from adequate and well-controlled studies of AMBELVIST in adults, with additional pharmacokinetic and safety data from 93 pediatric patients aged 28 days to less than 18 years who received one 0.01 mmol/kg dose of AMBELVIST and underwent MRI of any body region.1

 

AMBELVIST is associated with a Boxed Warning regarding risks associated with intrathecal administration and nephrogenic systemic fibrosis and is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST. Additionally, there are Warnings and Precautions related to hypersensitivity reactions, gadolinium retention, acute kidney injury and interference with lesion visualization. Please see AMBELVIST Important Safety Information below for additional information.

 

BAYER PERSPECTIVE ON AMBELVIST APPROVAL: 
Bayer has played a pioneering role in MRI contrast agent development, having launched the first GBCA in 1988, and is now adding AMBELVIST to its radiology portfolio as the lowest-dose mGBCA approved in the U.S.

 

“At Bayer, our focus has always been on enhancing patient care, and we are proud to introduce AMBELVIST as our next-generation option for contrast-enhanced MRI,” said Jill Carbone, Vice President and Head of Radiology, North America Product & Pipeline, Bayer. “As a lower-gadolinium-dose GBCA, AMBELVIST supports healthcare providers in adhering to growing clinical guidance to utilize the lowest gadolinium dose necessary to adequately image patients.”4


INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS
AMBELVIST® (gadoquatrane) is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in:

  • the central nervous system (brain, spine, and associated tissues)
  • the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) 

 

IMPORTANT SAFETY INFORMATION

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS

Risk Associated with Intrathecal Use
Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. AMBELVIST is not approved for intrathecal use.


Nephrogenic Systemic Fibrosis
GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of AMBELVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.


The risk for NSF appears highest among patients with:

  • Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2), or
  • Acute kidney injury

 

Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension, or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
For patients at highest risk for NSF, do not exceed the recommended AMBELVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.


Contraindication and Important Information about Hypersensitivity Reactions: AMBELVIST® is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST®. Serious hypersensitivity reactions have occurred with GBCAs. Before AMBELVIST® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma, and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to AMBELVIST®.

 

Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible.

 

Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of some GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.

 

Interference with Lesion Visualization 
As with other GBCAs, AMBELVIST® may obscure certain lesions that are visible on non-contrast MRI. When available, non-contrast MRI images should be reviewed during the interpretation of AMBELVIST® MRI scans.

 

Adverse Reactions: The most frequently observed adverse reactions (incidence ≥ 0.2%) were dizziness, headache, injection site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus. 
 

Please click here for the Full Prescribing Information for AMBELVIST®.

 


About Radiology at Bayer
Bayer’s Radiology business is a world leader among medical imaging solutions providers. The business transforms insight into technology and services with the goal of providing radiology solutions to help its customers enhance patient care. Its leading radiology portfolio features contrast agents and devices to help enable precise dose administration across modalities, equipment services, informatics and connected solution offerings.

 

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. 

 

Contact for media inquiries:
Elaine Colón
Phone: +1-732-236-1587
Email: elaine.colon@bayer.com

 

Contact for investor inquiries:
Bayer Investor Relations Team
Phone: +49 214 30-72704 
Email: ir@bayer.com 
www.bayer.com/de/investoren/ir-team

 

Forward-Looking Statements 
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 

 

References
1 Bayer Pharmaceuticals. AMBELVIST (gadoquatrane) [package insert]. U.S. Food and Drug Administration. Available at: https://labeling.bayerhealthcare.com/html/products/pi/ambelvist_PI.pdf.
2 Bracco. Vueway (gadopiclenol) package insert. U.S. Food and Drug Administration. Available at: http://www.bracco.com/sites/default/files/2022-11/us-en-spc-vueway.pdf.
3 National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health. Magnetic Resonance Imaging (MRI). Available at: https://www.nibib.nih.gov/science-education/science-topics/magnetic-resonance-imaging-mri. Accessed: 15 April 2026.
4 ACR manual on contrast media (2026) ACR. Available at: https://www.acr.org/clinical-resources/clinical-tools-and-reference/contrast-manual. Accessed: 15 April 2026.