Elucirem (gadopiclenol) is FDA-Approved for Contrast-Enhanced MRI

Elucirem (gadopiclenol) is FDA-Approved for Contrast-Enhanced MRI

Elucirem (gadopiclenol) is indicated for use in adults and children aged 2 years and older, for contrast-enhanced MRI.

Contrast-enhanced magnetic resonance imaging (MRI) can be done to increase the visualization of some medical conditions such as multiple sclerosis, cancerous growth, herniated discs and bone infections.

Gadolinium-based contrast agents (GBCAs), superparamagnetic iron oxide (SPIO), superparamagnetic iron–platinum particles (SIPPs), manganese (II) chelates such as mangafodipir and perflubron (a type of perfluorocarbon) are some examples of currently used contrast agents.

Guerbet, a pharmaceutical company based in France that specializes in medical imaging, obtained US Food and Drug Administration (FDA) approval for Elucirem (gadopiclenol), a new macrocyclic GBCA. Elucirem is indicated for use in adults and children aged 2 years and older, for contrast-enhanced MRI.

What is Unique About Elucirem?

Elucirem is the novel MRI contrast agent that has gadopiclenol as its active substance. Elucirem allows for detection and visualization of lesions with abnormal vascularity in the central nervous system (CNS) and other body regions such as the head and neck, thorax, abdomen, pelvis and musculoskeletal system.

Gadopiclenol was designed with two sites for water molecule exchange, which increases relaxivity and contrast. Therefore, Elucirem can be used at half the standard dose of gadolinium compared to other non-specific GBCAs and addresses doctors’ concerns about gadolinium exposure.

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Clinical Trials of Elucirem

Two Phase III clinical trials were conducted to assess the safety and efficiency of Elucirem as a potential MRI contrast agent.

The Phase III PICTURE trial was a multi-center, international, prospective, double-blind, randomized, controlled, cross-over with comparator trial. This clinical trial involved 260 participants who were due to a routine contrast-enhanced MRI of the CNS because they had known or highly suspected CNS lesion(s) with focal areas of disrupted blood brain barrier.

The Phase III PROMISE trial was a prospective, international, multi-center, randomized, double-blind, controlled and cross-over trial. This trial evaluated gadopiclenol for lesion visualization in 304 patients who were referred for contrast-enhanced MRI of body regions.

As both clinical trials had a cross-over design, each patient received gadopiclenol for the first MRI and then gadobutrol for the second MRI.

Both clinical trials showed that Elucirem provided non-inferior results for the visualization and detection of lesions of the CNS and other body regions at half the gadolinium dose of gadobutrol. Also, examination with Elucirem was superior compared to examination with no contrast agent.

“As a pioneer in MR imaging, thanks to the success of our first gadolinium-based macrocyclic contrast agent, we are delighted with the FDA approval of Elucirem. This approval allows patients and practitioners to benefit from the innovations brought by Elucirem,” said David Hale, Chief Executive Officer of Guerbet Group, in the company’s press release.