Gadopiclenol, sold under the brand name Elucirem or Vueway among others, is a contrast agent used with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system and in the body. Gadopiclenol is a paramagnetic macrocyclic non-ionic complex of gadolinium.

Gadopiclenol was approved for medical use in the United States in September 2022, and in the European Union in December 2023. Developed initially by Guerbet with intellectual property contributions from Bracco Imaging, gadopiclenol was commercialized following a strategic collaboration between the companies for manufacturing, research, and distribution.

Pharmacology

Gadopiclenol has a higher relaxivity compared with standard gadolinium-based contrast agents (GBCAs). The higher relaxivity allows for a lower dose of gadopiclenol, reducing the total amount of gadolinium administered to the patient while preserving imaging quality. Gadopiclenol was approved by the FDA with a recommended dose of 0.05 mmol/kg for adults and pediatric patients aged 2 years and older. This is half the dose of standard macrocyclic GBCAs, which have a recommended dose of 0.1 mmol/kg.

Safety

On 11/4/2025, the facility that manufactures Vueway and Elucirem's owner was sent an FDA Warning Letter for "significant violations of Current Good Manufacturing Practice (CGMP) regulations," notifying it that its "drug products are adulterated" and "Your firm released the above batches with OOS endotoxin failures for U.S. distribution."

An €86 million investment to remedy the shortcomings that resulted in the failed FDA inspection and a €10 million destroyed inventory write off should allow manufacturing of Elucirem and Vueway to return to normal by 2027, after an anticipated positive FDA inspection in late 2026.

Despite requiring half the dose of competitors, it carries a warning, like all GBCAs, which warns against intrathecal use, and mandates patient screening for kidney problems, that the recommended dose not be exceeded, and that sufficient time elapse for elimination before re-administration.

Society and culture

European Union

Gadopiclenol was approved for medical use in the United States in September 2022 by the Food and Drug Administration.

In October 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Elucirem, intended for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and, visualization of pathologies when diagnostic information is essential and not available with unenhanced MRI. The applicant for this medicinal product is Guerbet. In October and December 2023, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal products Elucirem and Vueway, intended for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and, visualization of pathologies when diagnostic information is essential and not available with unenhanced MRI. Gadopiclenol was approved for medical use in the European Union in December 2023.

Brand names

Gadopiclenol is the international nonproprietary name.

Gadopiclenol is sold under the brand names Vueway and Elucirem.

External links

  • Clinical trial number for "Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) (PICTURE)" at ClinicalTrials.gov
  • Clinical trial number for "Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) (PROMISE)" at ClinicalTrials.gov