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 · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed candidiasis, invasive 3 milestones | |||||
| Filed | UK (MHRA) | — | candidiasis, invasive | 2022-11-16 | “the MHRA has accepted a marketing authorisation application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients.” mundipharma.com ↗ |
| Filed | EU (EMA) | — | candidiasis, invasive | 2022-08-22 | “the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for rezafungin for the treatment of invasive candidiasis in adult patients.” mundipharma.com ↗ |
| Filed | US (FDA) | — | candidiasis, invasive | — | “A New Drug Application was recently submitted to the US Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis the USA.” mundipharma.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| 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| Phase 1 | NCT06329518 | Jul → Dec 2024 | infectious disease with sepsis | Hartford Hospital | Withdrawn | No outcome recorded |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 Stop: Enrollment |
| 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 · 2 met primary | ||||||
| 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 | Met primary |
| Phase 3 | NCT03667690 | Oct 2018 → Oct 2021 | candidemia | Cidara Therapeutics Inc. | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06985758 | Jan → Dec 2026 expected | infectious peritonitis | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-04-27 | Mundipharma Research Limited | Results MUNDIPHARMA ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE III RESPECT TRIAL ASSESSING ▼REZZAYO® (REZAFUNGIN) FOR THE PROPHYLAXIS OF INVASIVE FUNGAL DISEASES IN ALLOGENEIC HAEMATOPOIETIC STEM CELL TRANSPLANTATION PATIENTS mundipharma.com ↗
The ReSPECT study met its primary endpoint for US Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards for fungal-free survival at Day 90, showing non-inferiority of rezafungin vs. SAR (60.7% vs. 59.0%, respectively). |
| 2026-04-27 | CorMedix | Results CORMEDIX THERAPEUTICS ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE III RESPECT TRIAL ASSESSING REZZAYO® FOR THE PROPHYLAXIS OF INVASIVE FUNGAL DISEASES IN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION PATIENTS cormedix.com ↗
The ReSPECT study met its primary endpoint for FDA and EMA for fungal-free survival at Day 90 showing non-inferiority vs. SAR, with 60.7% fungal-free survival at Day 90 for rezafungin compared to 59.0% for standard antimicrobial regimen. |
| 2023-12-22 | Mundipharma Research Limited | Regulatory Mundipharma announces European approval of REZZAYO® (rezafungin) for the treatment of Invasive Candidiasis in adults mundipharma.com ↗
The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority* for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. |
| 2023-10-13 | Mundipharma Research Limited | Regulatory Mundipharma and Cidara Therapeutics receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults mundipharma.com ↗
Mundipharma and Cidara Therapeutics (Nasdaq: CDTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults. |
| 2022-11-16 | Mundipharma Research Limited | Regulatory Napp announces acceptance of their Rezafungin Marketing Authorisation Application for the Treatment of Invasive Candidiasis to the UK Medicines and Healthcare Products Regulatory Agency mundipharma.com ↗
Napp today announces that the MHRA has accepted a marketing authorisation application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients. |
| 2022-08-22 | Mundipharma Research Limited | Regulatory European Medicines Agency accepts rezafungin marketing authorisation application for the treatment of invasive candidiasis mundipharma.com ↗
Mundipharma today announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for rezafungin for the treatment of invasive candidiasis in adult patients. |
| 2022-04-25 | Mundipharma Research Limited | Results Mundipharma and Cidara Therapeutics Announce First Presentation of Results from Global Phase 3 ReSTORE Trial of Rezafungin for Treatment of Candidemia and/or Invasive Candidiasis Demonstrating its Positive Efficacy and Safety Profile mundipharma.com ↗
The data, presented in a late-breaking poster, showed non-inferiority for rezafungin dosed once-weekly compared to caspofungin, the current standard of care, dosed once-daily, for both primary endpoints. |
| 2022-03-03 | Mundipharma Research Limited | Regulatory Rezafungin Awarded Promising Innovation Medicine (PIM) Designation by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the Treatment of Invasive Candidiasis mundipharma.com ↗
Mundipharma and Cidara Therapeutics, Inc. (NASDAQ: CDTX) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has granted rezafungin Promising Innovative Medicine (PIM) designation for the treatment of invasive candidiasis. |
| 2021-12-14 | Mundipharma Research Limited | Results Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis mundipharma.com ↗
Both results demonstrated statistical non-inferiority of rezafungin dosed once-weekly, versus caspofungin dosed once-daily, the current standard of care. |
| 2021-01-26 | Mundipharma Research Limited | Regulatory Orphan Drug Designation granted to rezafungin in EU for the treatment of invasive candidiasis mundipharma.com ↗ |
All press releases naming this drug 14 releases
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 NCT06794554 ↗ |
| 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 ↗ |