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Trade names | Elucirem, Vueway |
AHFS/Drugs.com | Micromedex Detailed Consumer Information |
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Routes of administration | Intravenous |
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Pharmacokinetic data | |
Metabolism | None[2] |
Excretion | Kidneys[2] |
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Chemical and physical data | |
Formula | C35H54GdN7O15 |
Molar mass | 970.10 g·mol−1 |
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Gadopiclenol, sold under the brand name Elucirem 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.[2][5] Gadopiclenol is a paramagnetic macrocyclic non-ionic complex of gadolinium.[2]
Gadopiclenol was approved for medical use in the United States in September 2022[2][6][7] and in the European Union in December 2023.[3][4]
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.[2][8][9]
Gadopiclenol was approved for medical use in the United States in September 2022 by the Food and Drug Administration.[2][10]
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.[11] The applicant for this medicinal product is Guerbet.[11] In October 2023, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product 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.[12] The applicant for this medicinal product is Bracco Imaging S.p.A.[12] The EMA approved gadopiclenol for medical use in the EU on December 2023.[3][4]
Gadopiclenol is the international nonproprietary name.[13]
Gadopiclenol is sold under the brand names Elucirem and Vueway.[3][4]