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 | ENROLLING_BY_INVITATION | 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2024/03/26 | Phase 1 | Withdrawn | |||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 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 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 12/22/2023 | ||
Authorised | 12/22/2023 | ||
Authorised | 12/22/2023 | ||
Authorised | 12/22/2023 |
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. |