Last reviewed 2026-05-14 · How we verify

Eovist (gadoxetate)

Eovist (generic name: gadoxetate) is a gadoxetate drug developed by Bayer. It is currently FDA-approved (first approved 2008) for Liver MRI for lesion detection and characterization.

Eovist works by accumulating in liver cells and providing a contrast signal in MRI scans.

Gadoxetate (Eovist), marketed by Bayer, is a liver-specific MRI contrast agent used primarily for lesion detection and characterization. Its key strength lies in its mechanism of accumulating in liver cells, enhancing the clarity of MRI scans, which aids in accurate diagnosis. The primary risk to consider is the key composition patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Mechanism of action

Gadoxetate disodium is paramagnetic compound and develops magnetic moment when placed in magnetic field. The relatively large magnetic moment produced by gadoxetate disodium results in local magnetic field, yielding enhanced relaxation rates (shortening of relaxation times) of water protons in the vicinity of the paramagnetic agent, which leads to an increase in signal intensity (brightening) of blood and tissue.In MRI, visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occur with 1) differences in proton density; 2) differences of the spin-lattice or longitudinal relaxation times (T1); and 3) differences in the spin-spin or transverse relaxation time (T2). When placed in magnetic field, gadoxetate disodium decreases the T1 and T2 relaxation time in target tissue. At the recommended dose, the effect is observed with greatest sensitivity in T1-weighted MR sequences.

Approved indications

• Liver MRI for lesion detection and characterization

Boxed warnings

• 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. EOVIST is not approved for intrathecal use [see Warnings and Precautions (5.1) ]. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of EOVIST 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/1.73m 2 ), 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 EOVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.2) ]. WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning. Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. EOVIST is not approved for intrathecal use. ( 5.1 ) GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of EOVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), 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. ( 5.2 )

Common side effects

• Nausea
• Headache
• Feeling hot
• Dizziness
• Back pain
• Vomiting
• Blood pressure increased
• Injection site reactions (pain, burning, coldness, extravasation, irritation)
• Dysgeusia
• Paresthesia
• Flushing
• Parosmia

Drug interactions

• EOVIST (caloxetate trisodium)

Key clinical trials

• Abbreviated MRI Using Gadoxetic Acid Versus CT for Surveillance of Recurrent HCC After Curative Treatment (NA)
• A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer (PHASE2)
• Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients With Cirrhosis (PHASE4)
• REGULUS: MRI-guided Adaptive SABR for Liver Cancers (PHASE2)
• Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years (PHASE4)
• Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions (NA)
• PET/MRI of Primary Sclerosing Cholangitis
• Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Eovist CI brief — competitive landscape report
• Eovist updates RSS · CI watch RSS
• Bayer portfolio CI

Frequently asked questions about Eovist

Related

• Drug class: All gadoxetate drugs
• Manufacturer: Bayer — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for Liver MRI for lesion detection and characterization

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing