Last reviewed 2026-04-20 · How we verify

Elucirem (GADOPICLENOL)

Gadopiclenol enhances MRI image brightness by altering water proton relaxation rates in a magnetic field.

At a glance

Mechanism of action

Gadopiclenol is a gadolinium-based contrast agent that, when placed in a magnetic field, develops a magnetic moment. This magnetic moment changes the relaxation rates of nearby water protons, which increases the brightness of tissues in MRI images.

Approved indications

• Detect and visualize lesions with abnormal vascularity with MRI

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. Vueway 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 Vueway 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 m 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 (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended Vueway 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. Vueway 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 Vueway 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/1.73 m 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

• Injection site pain
• Headache
• Nausea
• Injection site warmth
• Injection site coldness
• Dizziness
• Localized swelling
• Erythema

Key clinical trials

• Screening for Brain Metastases (PHASE2)
• Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease (NA)
• Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas (PHASE3)
• Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease (PHASE3)
• ELUDYN: Assessment of Intra-individual Variability of Vascular Dynamics of Gadopiclenol Injection Parameters in Contrast-enhanced MRI (PHASE4)
• Randomized Comparison of Contrast Agents Gadopiclenol and Gadobutrol in the Workup of Incidental Renal and Adrenal Findings (PHASE4)
• Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age (PHASE2)
• Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) (PHASE3)

Patents

Primary sources

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