Chemistry:Gadopiclenol
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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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| Metabolism | None[1] |
| Excretion | Kidneys[1] |
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| 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.[1][4] Gadopiclenol is a paramagnetic macrocyclic non-ionic complex of gadolinium.[1]
Gadopiclenol was approved for medical use in the United States in September 2022.[1][5][6] Gadopiclenol was approved for medical use in the European Union in December 2023.[2][3]
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.[1][7][8]
Society and culture
Legal status
In October 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency 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.[9] The applicant for this medicinal product is Guerbet.[9] 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.[10] The applicant for this medicinal product is Bracco Imaging S.p.A.[10]
Gadopiclenol was approved for medical use in the United States in September 2022,[1][11] and in the European Union in December 2023.[2][3]
Brand names
Gadopiclenol is the international nonproprietary name.[12]
Gadopiclenol is sold under the brand names Elucirem and Vueway.[2][3]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 "Elucirem- gadopiclenol injection". 12 October 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ca582f31-1042-487f-82e4-533f1b541902.
- ↑ 2.0 2.1 2.2 2.3 "Elucirem PI". 8 December 2023. https://ec.europa.eu/health/documents/community-register/html/h1772.htm.
- ↑ 3.0 3.1 3.2 3.3 "Vueway PI". 8 December 2023. https://ec.europa.eu/health/documents/community-register/html/h1773.htm.
- ↑ "Review of the Efficacy and Safety of Gadopiclenol: A Newly Emerging Gadolinium-Based Contrast Agent". Cureus 15 (8): e43055. August 2023. doi:10.7759/cureus.43055. PMID 37680433.
- ↑ "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.
- ↑ "Novel Drug Approvals for 2022". U.S. Food and Drug Administration (FDA). 3 October 2022. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022.
This article incorporates text from this source, which is in the public domain.
- ↑ "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. May 2023. doi:10.1097/RLI.0000000000000944. PMID 36729404.
- ↑ "Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI". Radiology (Radiological Society of North America) 308 (1): e222612. July 2023. doi:10.1148/radiol.222612. ISSN 0033-8419. PMID 37462494.
- ↑ 9.0 9.1 "Elucirem EPAR". 12 October 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/elucirem. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ 10.0 10.1 "Vueway EPAR". 12 October 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/vueway. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Drug Approval Package: Elucirem". U.S. Food and Drug Administration (FDA). 20 October 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/216986Orig1s000TOC.cfm.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information 32 (3). 2018.
External links
- 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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