Chemistry:Rezafungin

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Rezafungin, sold under the brand name Rezzayo (by Melinta Therapeutics), is a medication used for the treatment of invasive candidiasis.[1] It is an echinocandin antifungal[2][3] that acts as a fungal β-glucan synthase inhibitor.[4]

Rezafungin was approved for medical use in the United States in March 2023,[2][5][4] and in the European Union in December 2023.[1][6]

Medical uses

In the United States, rezafungin is indicated in adults who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.[2]

In the European Union, rezafungin is indicated for the treatment of invasive candidiasis in adults.[1]

Rezafungin, while remaining a hydrophilic compound, exhibits a volume of distribution more than twice that of caspofungin.[7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis.[8][9]

Society and culture

Rezafungin was approved for medical use in the United States in March 2023,[2][10][11] The FDA granted the application for rezafungin orphan drug, fast track, and priority review designations.[12]

In October 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rezzayo, intended for the treatment of invasive candidiasis in adults.[1] The applicant for this medicinal product is Mundipharma GmbH.[1] Rezafungin was approved for medical use in the European Union in December 2023.[6]

Brand names

Rezafungin is the international nonproprietary name.[13]

Rezafungin is sold under the brand name Rezzayo.[1]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 "Rezzayo EPAR". 12 October 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  2. ↑ 2.0 2.1 2.2 2.3 Cite error: Invalid <ref> tag; no text was provided for refs named Rezzayo FDA label
  3. ↑ "Review of the Novel Echinocandin Antifungal Rezafungin: Animal Studies and Clinical Data". Journal of Fungi 6 (4): 192. September 2020. doi:10.3390/jof6040192. PMID 32998224. 
  4. ↑ 4.0 4.1 "Rezafungin: First Approval". Drugs 83 (9): 833–840. June 2023. doi:10.1007/s40265-023-01891-8. PMID 37212966. https://figshare.com/articles/online_resource/Rezafungin_First_Approval/22756766. 
  5. ↑ "Rezzayo approved by FDA amid rapid Candida auris spread". March 23, 2023. https://www.thepharmaletter.com/article/rezzayo-approved-by-fda-amid-rapid-candida-auris-spread. 
  6. ↑ 6.0 6.1 Cite error: Invalid <ref> tag; no text was provided for refs named Rezzayo Product information
  7. ↑ "Echinocandins Pharmacokinetics: A Comprehensive Review of Micafungin, Caspofungin, Anidulafungin, and Rezafungin Population Pharmacokinetic Models and Dose Optimization in Special Populations". Clinical Pharmacokinetics 64 (1): 27–52. January 2025. doi:10.1007/s40262-024-01461-5. PMID 39707078. 
  8. ↑ "Salvage therapy of complicated Candida albicans spondylodiscitis with Rezafungin". European Journal of Clinical Microbiology & Infectious Diseases. March 2025. doi:10.1007/s10096-025-05117-5. PMID 40163284. 
  9. ↑ "Salvage Therapy with Rezafungin for Candida parapsilosis Spondylodiscitis: A Case Report from Expanded Access Program". Microorganisms 12 (5): 903. April 2024. doi:10.3390/microorganisms12050903. PMID 38792732. 
  10. ↑ "Novel Drug Approvals for 2023". 22 December 2023. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2023. 
  11. ↑ "Drug Approval Package: Rezzayo". 18 April 2023. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217417Orig1s000TOC.cfm. 
  12. ↑ (PDF) New Drug Therapy Approvals 2023 (Report). January 2024. https://www.fda.gov/media/175253/download. Retrieved 9 January 2024. 
  13. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information 32 (1). 2018. 



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