Contents

Gadopiclenol

Gadopiclenol

Clinical data
Trade names	Elucirem, Vueway
AHFS/Drugs.com	Micromedex Detailed Consumer Information
License data	US DailyMed: Gadopiclenol
Routes of administration	Intravenous
ATC code	V08CA12 (WHO)
Legal status
Legal status	US: WARNING[1]Rx-only[2] EU: Rx-only[3][4]
Pharmacokinetic data
Metabolism	None[2]
Excretion	Kidneys[2]
Identifiers
IUPAC name 2-[3,9-bis[1-carboxylato-4-(2,3-dihydroxypropylamino)-4-oxobutyl]-3,6,9,15-tetrazabicyclo[9.3.1]pentadeca-1(15),11,13-trien-6-yl]-5-(2,3-dihydroxypropylamino)-5-oxopentanoate;gadolinium(3+)
CAS Number	933983-75-6
PubChem CID	16223405
ChemSpider	17350646
UNII	S276568KOY
KEGG	D12435
Chemical and physical data
Formula	C35H54GdN7O15
Molar mass	970.10 g·mol−1
3D model (JSmol)	Interactive image
SMILES [Gd+3].OCC(O)CNC(=O)CCC(N1CCN(Cc2cccc(CN(CC1)C(CCC(=O)NCC(O)CO)C(=O)[O-])n2)C(CCC(=O)NCC(O)CO)C(=O)[O-])C(=O)[O-]
InChI InChI=1S/C35H57N7O15.Gd/c43-19-24(46)14-36-30(49)7-4-27(33(52)53)40-10-12-41(28(34(54)55)5-8-31(50)37-15-25(47)20-44)17-22-2-1-3-23(39-22)18-42(13-11-40)29(35(56)57)6-9-32(51)38-16-26(48)21-45;/h1-3,24-29,43-48H,4-21H2,(H,36,49)(H,37,50)(H,38,51)(H,52,53)(H,54,55)(H,56,57);/q;+3/p-3 Key:GNRQMLROZPOLDG-UHFFFAOYSA-K

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]

^ "Novel Drug Approvals for 2022". U.S. Food and Drug Administration (FDA). 3 October 2022. Archived from the original on 25 March 2022. Retrieved 16 October 2022. This article incorporates text from this source, which is in the public domain.

• Clinical trial number NCT03996447 for "Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) (PICTURE)" at ClinicalTrials.gov
• Clinical trial number NCT03986138 for "Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) (PROMISE)" at ClinicalTrials.gov

This pharmacology-related article is a stub. You can help Wikipedia by expanding it.