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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/27 | Phase 2 | Not yet recruiting | |||
2025/01/14 | Phase 3 | Not yet recruiting | Fernanda P Silveira, MD, MS | ||
2024/03/26 | Phase 1 | Withdrawn | |||
2023/04/28 | Phase 2 | Recruiting | |||
2022/09/09 | Phase 1 | Terminated | |||
2020/04/30 | Phase 3 | Recruiting | |||
2019/10/07 | Phase 1 | Terminated | |||
2018/09/12 | Phase 3 | Completed | |||
2016/04/12 | Phase 2 | Completed |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
INTRAVENOUS | 200 mg in 1 1 | 2022/06/08 | 70842-240 |
EMA Approved Products
Product Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|---|---|---|---|---|---|---|---|
EMEA/H/C/005900 | Germany | Orphan | Authorised | 2023/12/22 | 2023/10/12 | N/A |
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval Number |
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No HSA products found
No HSA products found for this drug
NMPA Approved Products
Product Name | Approval Number | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No NMPA products found
No NMPA products found for this drug
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Registration Date |
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No PPB products found
No PPB products found for this drug
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Registration Date | Ingredient |
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No TGA products found
No TGA products found for this drug