Gadopiclenol Explained

Tradename:Elucirem, Vueway
Dailymedid:Gadopiclenol
Routes Of Administration:Intravenous
Atc Prefix:V08
Atc Suffix:CA12
Legal Us:Rx-only
Legal Us Comment:[1]
Legal Eu:Rx-only
Metabolism:None
Excretion:Kidneys
Cas Number:933983-75-6
Pubchem:16223405
Chemspiderid:17350646
Unii:S276568KOY
Kegg:D12435
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+)
C:35
H:54
Gd:1
N:7
O:15
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-]
Stdinchi: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
Stdinchikey: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] Gadopiclenol is a paramagnetic macrocyclic non-ionic complex of gadolinium.

Gadopiclenol was approved for medical use in the United States in September 2022[3] [4] and in the European Union in December 2023.[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.[7] [8]

Society and culture

Legal status

Gadopiclenol was approved for medical use in the United States in September 2022 by the Food and Drug Administration.[9]

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.[10] 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. The applicant for this medicinal product is Bracco Imaging S.p.A.[11] The EMA approved gadopiclenol for medical use in the EU on December 2023.[6]

Brand names

Gadopiclenol is the international nonproprietary name.[12]

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

Notes and References

  1. Web site: Elucirem- gadopiclenol injection . DailyMed . 12 October 2022 . 16 October 2022 . 16 October 2022 . https://web.archive.org/web/20221016202507/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ca582f31-1042-487f-82e4-533f1b541902 . live .
  2. Alsogati E, Ghandourah H, Bakhsh A . Review of the Efficacy and Safety of Gadopiclenol: A Newly Emerging Gadolinium-Based Contrast Agent . Cureus . 15 . 8 . e43055 . August 2023 . 37680433 . 10480682 . 10.7759/cureus.43055 . free .
  3. Guerbet announces U.S. Food and Drug Administration (FDA) approval of Elucirem (Gadopiclenol) . Guerbet . GlobeNewswire . 21 September 2022 . 16 October 2022 . 16 October 2022 . https://web.archive.org/web/20221016195934/https://www.globenewswire.com/news-release/2022/09/21/2520478/0/en/Guerbet-announces-U-S-Food-and-Drug-Administration-FDA-approval-of-Elucirem-Gadopiclenol.html . live .
  4. Web site: Novel Drug Approvals for 2022 . U.S. Food and Drug Administration (FDA) . 3 October 2022 . 16 October 2022 . 25 March 2022 . https://web.archive.org/web/20220325082235/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022 . live .
  5. Web site: Elucirem PI . Union Register of medicinal products . 8 December 2023 . 26 December 2023 . 13 December 2023 . https://web.archive.org/web/20231213231230/https://ec.europa.eu/health/documents/community-register/html/h1772.htm . live .
  6. Web site: Vueway PI . Union Register of medicinal products . 8 December 2023 . 26 December 2023 . 13 December 2023 . https://web.archive.org/web/20231213231231/https://ec.europa.eu/health/documents/community-register/html/h1773.htm . live .
  7. Loevner LA, Kolumban B, Hutóczki G, Dziadziuszko K, Bereczki D, Bago A, Pichiecchio A . Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial . . 58 . 5 . 307–313 . May 2023 . 36729404 . 10090311 . 10.1097/RLI.0000000000000944.
  8. Kuhl C, Csőszi T, Piskorski W, Miszalski T, Lee J, Otto PM . Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI . . Radiological Society of North America . 308 . 1 . July 2023 . e222612 . 0033-8419 . 10.1148/radiol.222612. 37462494 . 259949045 .
  9. Web site: Drug Approval Package: Elucirem . U.S. Food and Drug Administration (FDA) . 20 October 2022 . 4 December 2022 . 4 December 2022 . https://web.archive.org/web/20221204074828/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/216986Orig1s000TOC.cfm . live .
  10. Web site: Elucirem EPAR . European Medicines Agency (EMA) . 12 October 2023 . 28 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  11. Web site: Vueway EPAR . European Medicines Agency (EMA) . 12 October 2023 . 28 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  12. ((World Health Organization)) . 2018 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80 . WHO Drug Information . 32 . 3 . 10665/330907 . free . World Health Organization .

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