Guerbet Australia Announces Therapeutic Goods Administration (TGA) Approval of Elucirem™ (Gadopiclenol) for Use in Contrast- Enhanced MRI

Villepinte (France), June 2025 - Guerbet (FR0000032526 GBT), a global leader in medical imaging with more than 35 years’ experience in MRI, and the first to bring a macrocyclic Gadolinium Based Contrast Agent (GBCA) to the global market, is proud to announce that the Therapeutic Goods Administration (TGA) has approved Elucirem™ (Gadopiclenol) in Australia. This next generation, highly stable macrocyclic GBCA, has the highest relaxivity in its class for magnetic resonance imaging (MRI) and is indicated for use in adults and children aged 2 years and older1.

 

GBCAs improve the contrast between lesions and surrounding tissues by accelerating the relaxation of protons in water molecules thanks to the interaction with gadolinium atoms2. Gadopiclenol, the active substance of Elucirem™, has been designed to enable twice as much of this interaction, resulting in the highest relaxivity among all non-specific GBCAs2. This also allows use at half the conventional dose of other non-specific GBCAs.

 

Elucirem™ (Gadopiclenol) is approved for use to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues), and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system)1.

 

 

“Guerbet Australia is thrilled to announce the TGA approval of Elucirem™. This innovative contrast agent can reduce the amount of gadolinium administered to patients, addressing both patient safety and environmental concerns. By minimising gadolinium dosage, Elucirem™ helps mitigate the risk of gadolinium accumulation in water systems where it is not naturally present. We are excited for clinicians and patients to provide them with this next-generation agent, Elucirem™”.

Emily Kalaf, General Manager, Guerbet Australia/New Zealand

 

This registration complements its existing approvals in the United States, Europe, and the United Kingdom and strengthens Guerbet’s strategic commitment to advancing medical innovation with environmental responsibility. Elucirem™ will be available to the Australian market in both glass vials and plastic pre-filled syringes.

 

As with all MRI contrast agents, Elucirem™ may cause some side effects. The main precautions for consideration when using Elucirem™ are hypersensitivity reactions, patients with pacemakers, ferromagnetic vascular clips, and patients with renal impairment.

 

For more information regarding Elucirem™, please contact Guerbet Australia at [email protected] or call Customer Service at 1800 859 436. Alternatively, you can visit the TGA website to access the approved Product Information (PI) and Consumer Medicine Information (CMI) documents. https://www.tga.gov.au/

 

About Guerbet

Guerbet is a global leader in medical imaging, dedicated to improving patient care through innovation. With nearly a century of expertise, the company offers a comprehensive portfolio of pharmaceutical products, medical devices, and AI-driven solutions for diagnostic and interventional imaging. Guerbet invests 9% of its annual revenue in research and development, with dedicated innovation centers in France and the United States. The company (GBT) is publicly traded on Euronext Paris and reported €841 million in revenue in 2024.

For more information, visit: www.guerbet.com

  1. Guerbet Australia. Elucirem Product information. 2025. Available at https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2025-PI-01522-1&d=20250509172310101
  2. Robic, , Port, M., Rousseaux, O., Louguet, S., Fretellier, N., Catoen, S., Factor, C., Le Greneur, S., Medina, C., Bourrinet, P., Raynal, I., Idée, J. M., & Corot, C. (2019). Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Investigative radiology, 54(8), 475–484

 

Forward-looking statements

This press release may contain statements of a forward-looking nature, based on assumptions and predictions made by the management of the Guerbet group. Various known and unknown risks, uncertainties and other factors could lead to marked differences between the future results, financial situation1, development and performances of the company, and the estimates made here. These factors include those mentioned in the public reports of Guerbet, available on its website www.guerbet.com. The company assumes no responsibility whatsoever in relation to the updating of these forward-looking statements, or how they correspond to future events or developments.

 

Contact :

Matthieu BRUNEAU - Global corporate communication manager

Email : [email protected]

Phone : +33 6 78 83 89 96

WF PROM : P25003599 May 2025