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Rezafungin

Generic Name
Rezafungin
Brand Names
Rezzayo
Drug Type
Small Molecule
Chemical Formula
C63H85N8O17
CAS Number
1396640-59-7
Unique Ingredient Identifier
G013B5478J

Overview

Rezafungin is an echinocandin antifungal drug. Unlike other echinocandins such as caspofungin and micafungin, rezafungin has long‐acting pharmacokinetics and a high stability that allows for it to have long dosing intervals maintaining high plasma exposure. Rezafungin has a half-life higher than 130 hours and can be administered once a week instead of daily. It can only be administered intravenously but does not reach therapeutic concentrations in the central nervous system, eye and urine. Rezafungin is active against Candida albicans, Candida glabrata, Candida parapsilosis and Candida tropicalis, as well as other Candida and Aspergillus spp. Clinical studies have shown that rezafungin is non-inferior to caspofungin for the treatment of candidaemia and invasive candidiasis. In March 2023, the FDA approved rezafungin for injection for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.

Background

Rezafungin is an echinocandin antifungal drug. Unlike other echinocandins such as caspofungin and micafungin, rezafungin has long‐acting pharmacokinetics and a high stability that allows for it to have long dosing intervals maintaining high plasma exposure. Rezafungin has a half-life higher than 130 hours and can be administered once a week instead of daily. It can only be administered intravenously but does not reach therapeutic concentrations in the central nervous system, eye and urine. Rezafungin is active against Candida albicans, Candida glabrata, Candida parapsilosis and Candida tropicalis, as well as other Candida and Aspergillus spp. Clinical studies have shown that rezafungin is non-inferior to caspofungin for the treatment of candidaemia and invasive candidiasis. In March 2023, the FDA approved rezafungin for injection for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.

Indication

Rezafungin is indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.

Associated Conditions

  • Candidemia
  • Invasive Candidiasis

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Melinta Therapeutics, LLC
70842-240
INTRAVENOUS
200 mg in 1 1
6/8/2022

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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