Gadopiclenol

Table of contents

• What is gadopiclenol?
• How does gadopiclenol work?
• Which conditions is it used or studied for?
• How is gadopiclenol given?
• What do the clinical trials show?
• What side effects are known?

What is gadopiclenol?

Gadopiclenol is a gadolinium-based contrast agent used in magnetic resonance imaging (MRI). It is a chemically synthesised substance classified under ATC code V08CA12, a group of paramagnetic contrast media.^[2] It is marketed under the brand name Elucirem as a 0.5 mmol/mL solution for injection, with Guerbet as the marketing authorisation holder.^[2]

Gadopiclenol is an authorised medicine in the European Union. In December 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion extending its indication to adults and children from birth aged 2 years and older for contrast-enhanced MRI of the brain, spine, liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.^[5] It is for diagnostic use only and should be used when diagnostic information is essential and not available with unenhanced MRI.^[5]

How does gadopiclenol work?

Gadopiclenol contains gadolinium, a rare-earth metal that alters the magnetic properties of nearby water molecules in the body. When injected before an MRI scan, it increases the signal difference between normal and abnormal tissues, making pathologies with disrupted blood-brain barrier or abnormal vascularity easier to detect and visualise.^[5] A randomised study in healthy subjects found that gadopiclenol did not prolong the QTc interval, a measure of the heart's electrical cycle.^[6]

Which conditions is it used or studied for?

The EU Clinical Trials Register lists four Phase 3 trials of gadopiclenol across several conditions:

• Breast cancer — a completed pilot study compared gadopiclenol-enhanced multiparametric MRI findings with histopathological results from breast cancer surgery in 30 participants.^[2]
• Suspected vascular disease — an authorised study in 315 participants evaluates gadopiclenol-enhanced magnetic resonance angiography (MRA) for detecting steno-occlusive disease in the carotid, vertebrobasilar, peripheral, or abdominal/renal arteries.^[1]
• Cardiomyopathy, tetralogy of Fallot, or complex congenital heart disease — an authorised paediatric study in 30 children compares gadopiclenol against gadoterate meglumine for cardiac MRI.^[4]
• Perianal fistula associated with Crohn's disease — an authorised crossover study in 30 participants compares gadopiclenol against gadobutrol for detecting perianal fistulas.^[3]

The authorised indication covers contrast-enhanced MRI to improve detection and visualisation of pathologies with disruption of the blood-brain barrier and/or abnormal vascularity of the brain, spine, and associated tissues of the central nervous system, as well as the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.^[5]

How is gadopiclenol given?

Gadopiclenol is given as a solution for injection by intravenous use, either as an intravenous bolus injection or IV infusion.^[2] The product is supplied as Elucirem 0.5 mmol/mL solution for injection. In the registered trials, gadopiclenol is administered at a dose of 0.05 mmol/kg body weight, which is half the dose of the comparator agents gadoterate meglumine and gadobutrol, both given at 0.1 mmol/kg.^[4][3][1]

What do the clinical trials show?

Four Phase 3 clinical trials of gadopiclenol are listed in the EU Clinical Trials Register, all with gadopiclenol as the test substance.^[2] One trial is completed and three are authorised but not yet started. Together they plan to enrol a total of 405 participants, with the largest trial enrolling 315 and the three smaller trials enrolling 30 participants each.

What are the trials measuring?

The breast cancer trial measures the correlation between multiparametric MRI lesion characteristics — size, type, morphology, enhancement pattern and kinetics, laterality and location — and histopathological tumour parameters such as size, grade, histological type, lymph node status, lymphovascular invasion, nodal metastases and molecular subtype.^[2] The paediatric cardiac MRI trial measures overall image quality, including myocardium-to-blood pool contrast, and the detection of myocardial fibrosis using diagnostic confidence, contrast-to-noise ratio (CNR), and signal-to-noise ratio (SNR).^[4] The Crohn's disease trial measures the correct, verified detection of the perianal fistula tract on MRI.^[3] The vascular disease trial measures sensitivity and specificity for detecting clinically significant steno-occlusive disease in different vascular territories, using CT angiography and/or intra-arterial digital subtraction angiography as the standard of truth.^[1]

Who can take part in these trials?

The completed breast cancer trial enrolled adult patients with breast cancer scheduled for surgery. The vascular disease trial enrols adult patients with suspected vascular disease of the supra-aortic, peripheral, or abdominal/renal arteries. The paediatric cardiac MRI trial enrols children with cardiomyopathy, tetralogy of Fallot, or complex congenital heart disease. The Crohn's disease trial enrols adult patients with perianal fistula associated with Crohn's disease.

What side effects are known?

In a randomised study of gadopiclenol in healthy subjects, the substance did not prolong the QTc interval, a measure of the heart's electrical cycle that can be affected by some medicines.^[6] The CHMP summary of opinion does not list specific side effects but states that detailed recommendations will be described in the updated summary of product characteristics (SmPC).^[5]