Multiple clinical trials spanning Phase 1 to Phase 4 evaluate rezafungin acetate for fungal infections—such as candidemia, invasive candidiasis, pneumocystis pneumonia, chronic pulmonary aspergillosis, and candidal peritonitis—in high-risk populations, including critically ill surgical patients and liver transplant recipients. Sponsored by pharmaceutical companies, government agencies such as the National Institute of Allergy and Infectious Diseases, and academic institutions, these protocols range in recruitment status from actively recruiting and completed to terminated, withdrawn, and upcoming studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06774144 | ENROLLING_BY_INVITATION | Liver Transplant Infection; Fungal Infection |
Fernanda P Silveira, MD, MS |
2025-10-15 | PHASE3 |
| NCT06794554 | ACTIVE_NOT_RECRUITING | Chronic Pulmonary Aspergillosis |
Mundipharma Research Limited |
2025-06-30 | PHASE2 |
| NCT04368559 | COMPLETED | Candidemia; Mycoses; Fungal Infection; Fungemia; Invasive Candidiasis; Pneumocystis; Mold Infection; Invasive Fungal Disease; Prophylaxis of Invasive Fungal Infections; Aspergillus |
Mundipharma Research Limited |
2020-05-11 | PHASE3 |
| NCT06985758 | NOT_YET_RECRUITING | Candidal Peritonitis |
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
2025-09 | PHASE4 |
| NCT05835479 | RECRUITING | Pneumocystis Pneumonia |
Mundipharma Research Limited |
2023-11-14 | PHASE2 |
| NCT06329518 | WITHDRAWN | Sepsis |
Hartford Hospital |
2024-07-01 | PHASE1 |
| NCT05534529 | TERMINATED | Invasive Fungal Infections |
Mundipharma Research Limited |
2023-09-13 | PHASE1 |
| NCT03667690 | COMPLETED | Candidemia; Mycoses; Fungal Infection; Invasive Candidiases |
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2018-10-07 | PHASE3 |
| NCT04117607 | TERMINATED | Fungal Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2019-12-04 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2025-10-20)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).