The MRI contrast media market has a new option. On June 15, 2026, the U.S. Food and Drug Administration (FDA) approved Ambelvist® (gadoquatrane), a new gadolinium-based MRI contrast agent from Bayer. Ambelvist is approved for contrast-enhanced magnetic resonance imaging (MRI) and introduces an important distinction: it is currently the lowest-dose macrocyclic gadolinium-based contrast agent approved in the United States.
Below, you’ll find what radiology departments, hospitals, imaging centers, and healthcare providers should know about Ambelvist, including its approved uses, dosing, relaxivity, clinical trial results, safety information, and packaging, and how it compares with other gadolinium-based contrast agents.
Key Takeaways
- Ambelvist (gadoquatrane) is a macrocyclic gadolinium-based contrast agent from Bayer, approved by the FDA on June 15, 2026, for contrast-enhanced MRI in adults and pediatric patients, including term neonates.
- The recommended Ambelvist dose delivers 0.04 mmol Gd/kg, which Bayer reports is 60% less gadolinium than macrocyclic agents dosed at 0.1 mmol Gd/kg and 20% less than gadopiclenol.
- A tetrameric molecule with four gadolinium ions and high relaxivity lets Ambelvist produce contrast enhancement at a lower total gadolinium dose.
- Ambelvist is not automatically interchangeable with Gadavist or gadopiclenol agents, so compare indications, concentration, dosing, and packaging before changing an MRI contrast protocol.
- The label carries a boxed warning for intrathecal use and nephrogenic systemic fibrosis (NSF), so screen patients and review the full prescribing information before use.
Ambelvist (Gadoquatrane) Overview and Approved Uses
Ambelvist (Gadoquatrane) is an intravenous macrocyclic gadolinium-based contrast agent, or GBCA, manufactured by Bayer.
The FDA approved Ambelvist for use in adult and pediatric patients, including term neonates, with MRI to detect and visualize lesions with abnormal vascularity in:
- The central nervous system, including the brain, spine, and associated tissues
- The head and neck
- Thorax
- Abdomen
- Pelvis
- Musculoskeletal system
Ambelvist contains gadoquatrane, a next-generation macrocyclic GBCA with a novel tetrameric molecular structure and high relaxivity.
The table below summarizes the core product facts radiology and purchasing teams ask about first.
| Product detail | Ambelvist |
|---|---|
| Active ingredient | Gadoquatrane |
| Manufacturer | Bayer |
| Agent class | Macrocyclic gadolinium-based contrast agent (GBCA) |
| FDA approval | June 15, 2026 |
| Approved patients | Adults and pediatric patients, including term neonates |
| Route | Intravenous only (not approved for intrathecal use) |
| Concentration | 0.1 mmol/mL |
| Recommended dose | 0.01 mmol/kg (0.1 mL/kg), delivering 0.04 mmol Gd/kg |
Ambelvist Dose and Gadolinium Reduction
One of the most significant characteristics of Ambelvist is the amount of gadolinium administered per MRI examination.
The recommended dose of Ambelvist is 0.01 mmol/kg of gadoquatrane based on actual body weight, equivalent to an injection volume of 0.1 mL/kg.
Because each gadoquatrane molecule contains four chelated gadolinium ions, this corresponds to a gadolinium dose of 0.04 mmol Gd/kg.
Ambelvist is supplied at 0.1 mmol/mL, so its 0.1 mL/kg injection volume matches the weight-based volume used for Gadavist at its standard dose. Technologists can confirm this during contrast dosage calculation when Ambelvist is added to a protocol.
According to Bayer, that represents:
- 60% less gadolinium compared with macrocyclic GBCAs administered at 0.1 mmol Gd/kg.
- 20% less gadolinium compared with gadopiclenol administered at 0.05 mmol Gd/kg.
This makes Ambelvist the lowest-dose macrocyclic GBCA currently approved in the United States.
Why a Lower Gadolinium Dose Matters
Gadolinium-based contrast agents are widely used to improve visualization during MRI examinations. They can help radiologists identify and characterize lesions that may be difficult to evaluate using non-contrast MRI alone.
At the same time, clinical guidance generally supports using the lowest GBCA dose necessary to obtain adequate diagnostic imaging.
This can be particularly relevant for patients who may undergo repeated contrast-enhanced MRI examinations throughout their lives, including patients receiving ongoing imaging for neurological diseases, cancer, and other chronic conditions.
Studies have reported small amounts of gadolinium remaining in the brain, bone, and other tissues after GBCA exposure, which keeps contrast agent retention part of many formulary discussions. A lower dose per exam reduces the total gadolinium each patient receives.
A lower gadolinium dose does not automatically mean that one contrast agent is appropriate for every patient or every MRI examination. Contrast selection should be determined by qualified healthcare professionals based on the clinical circumstances and approved prescribing information.
Ambelvist and High Relaxivity
The ability to administer a lower gadolinium dose is related in part to the molecular design of gadoquatrane.
Ambelvist has a tetrameric structure, with each gadoquatrane molecule containing four chelated gadolinium ions. The agent was developed to provide high relaxivity, which relates to its ability to increase MRI signal intensity.
According to the prescribing information, the reported longitudinal relaxivity (r1) of gadoquatrane in human plasma at 37°C is:
- 1.5 Tesla: 47 L/mmol/sec
- 3.0 Tesla: 41 L/mmol/sec
This high-relaxivity design allows Ambelvist to provide contrast enhancement while delivering a lower overall gadolinium dose.
Relaxivity changes with MRI field strength, so facilities that run both 1.5T and 3T scanners should review Ambelvist protocols for each magnet.
Ambelvist Clinical Trial Results From the QUANTI Program
FDA approval of Ambelvist was supported by Bayer’s Phase III QUANTI clinical development program.
The studies evaluated gadoquatrane for contrast-enhanced MRI of the central nervous system and other body regions.
The clinical program demonstrated increased lesion visualization when combined pre-contrast and Ambelvist-enhanced MRI images were compared with pre-contrast images alone.
In descriptive analyses reported by Bayer, visualization scores and the number of lesions identified with Ambelvist at 0.04 mmol Gd/kg were similar to those observed with tested macrocyclic GBCAs administered at 0.1 mmol Gd/kg.
These findings supported FDA approval of Ambelvist for contrast-enhanced MRI in adults and pediatric patients, including term neonates.
Ambelvist vs. Gadavist
Because both products are manufactured by Bayer and are macrocyclic gadolinium-based MRI contrast agents, radiology departments may naturally compare Ambelvist vs. Gadavist.
The two products contain different active ingredients:
- Ambelvist: gadoquatrane
- Gadavist: gadobutrol
One of the most notable differences is their approved gadolinium dosing. Ambelvist delivers 0.04 mmol Gd/kg at its recommended dose, while standard Gadavist dosing for many approved indications delivers 0.1 mmol Gd/kg.
Ambelvist therefore provides a substantially lower gadolinium dose per examination for its approved indications.
However, the products should not be considered automatically interchangeable. Their indications, concentrations, dosing, packaging, administration requirements, and prescribing information should be reviewed when a facility evaluates its MRI contrast protocols. Facilities that already purchase gadobutrol should also compare carton sizes and contract pricing before changing their MRI contrast order.
Ambelvist vs. Gadopiclenol
Ambelvist may also be compared with newer high-relaxivity MRI contrast agents containing gadopiclenol, sold in the U.S. as Elucirem by Guerbet and Vueway by Bracco.
At their recommended doses, Ambelvist delivers 0.04 mmol Gd/kg compared with 0.05 mmol Gd/kg for gadopiclenol products.
According to Bayer, this represents approximately 20% less gadolinium.
For facilities reviewing newer low-dose MRI contrast options, factors such as approved indications, dosing, clinical performance, safety information, availability, packaging, workflow, and acquisition cost may all be relevant considerations.
Ambelvist vs. Gadavist vs. Gadopiclenol Comparison Table
This side-by-side view uses each product’s standard U.S. dose. Confirm current labeling before updating a protocol.
| Feature | Ambelvist | Gadavist | Gadopiclenol (Elucirem, Vueway) |
|---|---|---|---|
| Active ingredient | Gadoquatrane | Gadobutrol | Gadopiclenol |
| Manufacturer | Bayer | Bayer | Guerbet (Elucirem), Bracco (Vueway) |
| Gadolinium ions per molecule | Four (tetrameric) | One | One |
| Concentration | 0.1 mmol/mL | 1.0 mmol/mL | 0.5 mmol/mL |
| Injection volume | 0.1 mL/kg | 0.1 mL/kg | 0.1 mL/kg |
| Gadolinium dose | 0.04 mmol Gd/kg | 0.1 mmol Gd/kg | 0.05 mmol Gd/kg |
| Gadolinium saved with Ambelvist | Reference | 60% less | 20% less |
Ambelvist Approval for Pediatric MRI
Ambelvist is FDA-approved for adult and pediatric patients, including term neonates, for its indicated contrast-enhanced MRI applications. Bayer’s pediatric data included 93 patients aged 28 days to under 18 years who received a single 0.01 mmol/kg dose.
This broad age range may be particularly relevant to hospitals and imaging organizations that perform both adult and pediatric MRI examinations. Facilities that stock separate pediatric contrast media can review whether one macrocyclic agent covers both patient groups under their protocols.
How Ambelvist Is Administered
Ambelvist is administered intravenously.
The recommended dose for adults and pediatric patients, including term neonates, is:
| Dose measure | Value |
|---|---|
| Gadoquatrane dose | 0.01 mmol/kg |
| Injection volume | 0.1 mL/kg Ambelvist |
| Gadolinium delivered | 0.04 mmol Gd/kg |
According to Bayer’s prescribing information, Ambelvist may be administered manually or using a compatible MRI power injector at approximately 1 to 4 mL per second, followed by a 0.9% sodium chloride flush. Pediatric administration rates and flush volumes should be adjusted based on age.
Contrast-enhanced MRI can begin immediately following administration.
Ambelvist Packaging and Presentations
Bayer lists the following Ambelvist presentations, all at 0.1 mmol/mL. At 0.1 mL/kg, a 7.5 mL prefilled syringe covers a patient up to 75 kg, and a 10 mL syringe covers a patient up to 100 kg.
| Presentation | Sizes | Carton quantity |
|---|---|---|
| Vials | 0.2 mmol/2 mL | 3 per carton |
| Vials | 0.75 mmol/7.5 mL, 1 mmol/10 mL, 1.5 mmol/15 mL | 10 per carton |
| Prefilled syringes | 0.75 mmol/7.5 mL, 1 mmol/10 mL, 1.5 mmol/15 mL | 5 per carton |
| Imaging bulk packages | 3 mmol/30 mL, 6.5 mmol/65 mL | 10 per carton |
Ambelvist Safety Information
Like other gadolinium-based contrast agents, Ambelvist carries important safety considerations.
Its FDA prescribing information contains a boxed warning concerning intrathecal use and nephrogenic systemic fibrosis (NSF). Ambelvist is intended for intravenous administration and is not approved for intrathecal use.
NSF risk is highest in patients with chronic, severe kidney disease and in patients with acute kidney injury, so kidney function screening before administration remains part of standard GBCA practice. Our guide on gadolinium MRI contrast for patients with kidney disease explains current screening approaches.
The prescribing information also addresses gadolinium retention, hypersensitivity reactions, acute kidney injury, and other precautions.
Healthcare professionals should review the complete FDA-approved prescribing information before using Ambelvist and evaluate individual patient risk factors when determining whether contrast-enhanced MRI is appropriate.
What Ambelvist Means for the MRI Contrast Market
The introduction of Ambelvist expands the range of macrocyclic gadolinium-based contrast agents available to U.S. imaging providers.
Its combination of high relaxivity and a 0.04 mmol Gd/kg recommended gadolinium dose distinguishes it from established macrocyclic agents administered at 0.1 mmol Gd/kg and newer gadopiclenol agents administered at 0.05 mmol Gd/kg.
As hospitals and imaging centers evaluate their MRI contrast formularies, Ambelvist gives radiology departments another option to consider when balancing diagnostic performance, gadolinium exposure, workflow, availability, and cost.
Switching to Ambelvist: Clinical Benefits and Operational Factors
Radiologists and imaging directors weighing a move to Ambelvist should look at two things: what the agent offers patients and what changes inside the department. A lower gadolinium dose is the main clinical benefit, but a smooth transition depends on protocols, injector setup, inventory, and staff readiness.
| Area | What to evaluate |
|---|---|
| Gadolinium exposure (clinical) | Each exam delivers 0.04 mmol Gd/kg, 60% less than agents dosed at 0.1 mmol Gd/kg. This matters most for patients who need repeat contrast-enhanced MRI. |
| Image quality (clinical) | In descriptive QUANTI analyses, lesion visualization at the approved dose was similar to tested macrocyclic GBCAs at 0.1 mmol Gd/kg. |
| Patient coverage (clinical) | One agent is approved for adults and pediatric patients, including term neonates, across CNS and body regions. |
| Protocols and dosing (operational) | Update dosing charts and 1.5T and 3T protocols. Ambelvist and Gadavist share a 0.1 mL/kg volume but differ in concentration (0.1 vs. 1.0 mmol/mL), so label and store them clearly to prevent mix-ups. |
| Injector setup (operational) | Confirm power injector compatibility, the 1 to 4 mL per second flow rate, and saline flush settings for adult and pediatric exams. |
| Inventory (operational) | Match vial, prefilled syringe, and imaging bulk package sizes to scan volume, and plan how to use up current contrast stock during the changeover. |
| Staff training (operational) | Brief technologists and nurses on the new dose, the boxed warning for intrathecal use and NSF, and kidney function screening steps. |
A phased rollout lets a department start with one scanner or patient group, collect feedback from radiologists and technologists, and then expand. Updating your contrast media injection protocol and pairing the change with contrast injector training helps keep every shift on the same dosing and safety steps.
Request Ambelvist Pricing From Spectrum Medical Imaging Co.
For over 42 years, Spectrum Medical Imaging Co. has supplied contrast media and medical imaging products to more than 1,500 hospitals and healthcare providers nationwide, from large health systems to independent imaging centers and radiology practices. As an authorized dealer for Bayer, Bracco, GE HealthCare, and Guerbet, we help imaging teams compare MRI contrast agents on dose, packaging, and total cost.
Our contrast media specialists can review Ambelvist (gadoquatrane) alongside the contrast media you already stock, check current availability, and match vial or syringe sizes to your patient mix. We also supply the MRI injector syringes and tubing that keep your contrast workflow running, with nationwide shipping in 24 to 48 hours.
Call 800-859-6162 or request a quote to get Ambelvist pricing and availability for your facility.
Frequently Asked Questions About Ambelvist
What is Ambelvist used for?
Ambelvist is the brand name for gadoquatrane, a macrocyclic gadolinium-based contrast agent developed by Bayer for contrast-enhanced MRI. It helps radiologists detect and visualize lesions with abnormal vascularity in the central nervous system, including the brain and spine. It is also approved for the head and neck, thorax, abdomen, pelvis, and musculoskeletal system. The approval covers adults and pediatric patients, including term neonates.
When did the FDA approve Ambelvist?
The FDA approved Ambelvist on June 15, 2026. Bayer’s Phase III QUANTI clinical program supported the approval, with studies covering MRI of the central nervous system and other body regions. In descriptive analyses, lesion visualization with Ambelvist at 0.04 mmol Gd/kg was similar to tested macrocyclic GBCAs at 0.1 mmol Gd/kg. Ambelvist joins Gadavist and Eovist in Bayer’s MRI contrast portfolio.
Is Ambelvist a lower gadolinium dose than Gadavist?
Yes. At standard dosing, Ambelvist delivers 0.04 mmol Gd/kg, while Gadavist delivers 0.1 mmol Gd/kg, a 60% reduction in gadolinium per exam. Both agents use a 0.1 mL/kg injection volume because Ambelvist is supplied at 0.1 mmol/mL and Gadavist at 1.0 mmol/mL. The two products have different active ingredients, concentrations, and labeling, so they are not automatically interchangeable. Product selection should follow approved indications, prescribing information, and clinical requirements.
Is Ambelvist safe for patients with kidney disease?
Ambelvist carries a boxed warning for nephrogenic systemic fibrosis (NSF), the same NSF warning that appears on other GBCA labels. NSF risk is highest in patients with chronic, severe kidney disease and in patients with acute kidney injury. Clinicians should screen kidney function before administration and weigh the diagnostic need against the risk. The full prescribing information also covers acute kidney injury, gadolinium retention, and hypersensitivity reactions.
Where can imaging centers buy Ambelvist?
Hospitals, imaging centers, and radiology practices can contact Spectrum Medical Imaging Co. for current Ambelvist availability and pricing. Our team has supplied contrast media to healthcare providers nationwide for over 42 years and can compare Ambelvist with the MRI contrast agents you already purchase. We can also help match vial, prefilled syringe, or imaging bulk package sizes to your scan volume. Call 800-859-6162 or request a quote to get started.
