Drugs / Rezafungin
Rezafungin
also known as
CD101 · rezafungin acetate · Acetate de rezafungine · Acetato de rezafungina · Biafungin · Biafungin acetate · CD-101 ACETATE · CD101 Injection · +5 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | REZZAYO | — | 2026-07-16 | fda.gov ↗ |
| Approved | EU (EMA) | Rezzayo | — | 2023-12-22 | europa.eu ↗ |
| Approved | US (FDA) | REZZAYO | — | 2023-03-22 | fda.gov ↗ |
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06329518 | Jul → Dec 2024 | infectious disease with sepsis | Hartford Hospital | Withdrawn | No outcome recorded |
| Phase 1 | NCT05534529 | Sep 2023 → May 2024 | fungal infectious disease | Mundipharma Research Limited | Terminated | No outcome recorded |
| Phase 1 | NCT04117607 | Dec 2019 → May 2020 | fungal infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 1 | NCT02551549 | Sep 2015 → Jan 2016 | — | Cidara Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02516904 | Jul → Oct 2015 | — | Cidara Therapeutics Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06794554 | Jun 2025 → Nov 2026 expected | aspergillosis | Mundipharma Research Limited | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05835479 | Nov 2023 → May 2025 overdue | pneumocystosis | Mundipharma Research Limited | Recruiting | No outcome recorded |
| Phase 2 | NCT02734862 | Jul 2016 → Jun 2019 | candidemia | Cidara Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02733432 | Jun → Nov 2016 | vulvovaginal candidiasis | Cidara Therapeutics Inc. | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06774144 | Oct 2025 → Dec 2028 expected | fungal infectious disease | Fernanda P Silveira, MD, MS | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT04368559 | May 2020 → Jan 2026 | aspergillosis, candidemia, pneumocystosis | Mundipharma Research Limited | Completed | No outcome recorded |
| Phase 3 | NCT03667690 | Oct 2018 → Oct 2021 | candidemia | Cidara Therapeutics Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06985758 | Sep → Nov 2025 overdue | infectious peritonitis | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | Not yet recruiting | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rezafungin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06985758 ↗ |
| Known as | Acetate de rezafungine | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989945 ↗ |
| Known as | Acetato de rezafungina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989945 ↗ |
| Known as | Biafungin | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989945 ↗ |
| Known as | Biafungin acetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989945 ↗ |
| Known as | CD-101 ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989945 ↗ |
| Known as | CD101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02551549 ↗ |
| Known as | CD101 Injection | “ascending single doses of CD101 Injection administered IV to healthy adult subjects” NCT02516904 ↗ |
| Known as | rezafungin acetate | “Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate” NCT04117607 ↗1“The once-weekly IV echinocandin, rezafungin acetate, has demonstrated non-inferiority to caspofungin in the treatment of IC/C.” PMID 39529079 ↗ Nov 2024 |
| Known as | Rezafungin cation | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989945 ↗ |
| Known as | Rezafungin ion | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989945 ↗ |
| Known as | Rezzayo | “On 22 March 2023, the FDA approved rezafungin (Rezzayo) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.” PMID 38502709 ↗ Aug 2024 |
| Known as | SP-3025 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989945 ↗ |
| Known as | SP-3025 ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989945 ↗ |
| Modality | Other / unclassified | “Rezafungin is a novel echinocandin with exceptional stability and solubility and a uniquely long half-life allowing for front-loaded drug exposure with once-weekly dosing.” PMID 33438477 ↗ Jan 2021 |
| Route | Intravenous | “administered IV” NCT02516904 ↗ |