Gadopiclenol

Gadopiclenol
Clinical data
Trade namesElucirem, Vueway
AHFS/Drugs.comMicromedex Detailed Consumer Information
License data
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Pharmacokinetic data
MetabolismNone[2]
ExcretionKidneys[2]
Identifiers
  • 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
PubChem CID
ChemSpider
UNII
KEGG
Chemical and physical data
FormulaC35H54GdN7O15
Molar mass970.10 g·mol−1
3D model (JSmol)
  • [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=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][7] 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][8][9] and in the European Union in December 2023.[3][4][5][6]

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.[2][10][11]

Society and culture

Gadopiclenol was approved for medical use in the United States in September 2022 by the Food and Drug Administration.[2][12]

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.[3] The applicant for this medicinal product is Guerbet.[3] 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.[5] The applicant for this medicinal product is Bracco Imaging S.p.A.[5] Gadopiclenol was approved for medical use in the European Union in December 2023.[3][4][5][6]

Brand names

Gadopiclenol is the international nonproprietary name.[13]

Gadopiclenol is sold under the brand names Elucirem and Vueway.[3][4][5][6]

References

  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  2. ^ a b c d e f g h "Elucirem- gadopiclenol injection". DailyMed. 12 October 2022. Archived from the original on 16 October 2022. Retrieved 16 October 2022.
  3. ^ a b c d e f "Elucirem EPAR". European Medicines Agency (EMA). 12 October 2023. Retrieved 28 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. ^ a b c d "Elucirem PI". Union Register of medicinal products. 8 December 2023. Archived from the original on 13 December 2023. Retrieved 26 December 2023.
  5. ^ a b c d e f "Vueway EPAR". European Medicines Agency (EMA). 12 October 2023. Retrieved 28 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ^ a b c d "Vueway PI". Union Register of medicinal products. 8 December 2023. Archived from the original on 13 December 2023. Retrieved 26 December 2023.
  7. ^ Alsogati E, Ghandourah H, Bakhsh A (August 2023). "Review of the Efficacy and Safety of Gadopiclenol: A Newly Emerging Gadolinium-Based Contrast Agent". Cureus. 15 (8): e43055. doi:10.7759/cureus.43055. PMC 10480682. PMID 37680433.
  8. ^ "Guerbet announces U.S. Food and Drug Administration (FDA) approval of Elucirem (Gadopiclenol)" (Press release). Guerbet. 21 September 2022. Archived from the original on 16 October 2022. Retrieved 16 October 2022 – via GlobeNewswire.
  9. ^ "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. Public Domain This article incorporates text from this source, which is in the public domain.
  10. ^ Loevner LA, Kolumban B, Hutóczki G, Dziadziuszko K, Bereczki D, Bago A, et al. (May 2023). "Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial". Investigative Radiology. 58 (5): 307–313. doi:10.1097/RLI.0000000000000944. PMC 10090311. PMID 36729404.
  11. ^ Kuhl C, Csőszi T, Piskorski W, Miszalski T, Lee J, Otto PM (July 2023). "Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI". Radiology. 308 (1). Radiological Society of North America: e222612. doi:10.1148/radiol.222612. ISSN 0033-8419. PMID 37462494. S2CID 259949045.
  12. ^ "Drug Approval Package: Elucirem". U.S. Food and Drug Administration (FDA). 20 October 2022. Archived from the original on 4 December 2022. Retrieved 4 December 2022.
  13. ^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information. 32 (3). hdl:10665/330907.
  • 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


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