rezafungin
Trade name: REZZAYO
Small moleculeapprovedOrphan Drug FDAFast Track FDA
Approved
Mar 22, 2023
Clinical trial activity
9 trials · 7 clinical orgs · 2 marketing orgs
Phase 1
3
Phase 2
5
Phase 3
3
Phase 4
1
Earliest trial started Oct 31, 2018 (NCT03667690)
Timeline
2010s
- Feb 8, 2016
Orphan Drug Designation
- Jan 1, 2018
Cidara Therapeutics — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2019
Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2023
Mundipharma — Earliest Phase 2 Sponsor(trial)
- Mar 22, 2023
Cidara Therapeutics — Earliest FDA Approval
- Mar 22, 2023
Mundipharma — Marketing Organization
- Mar 22, 2023
Cidara Therapeutics — Marketing Organization
- Mar 22, 2023
Cidara Therapeutics — NDA Secondary Org
- Mar 22, 2023
Cidara Therapeutics — NDA Organization
Indications
Studied for
- Aspergillosis · Phase 2
- Aspergillus · Phase 3
- Candidemia · Phase 3
- Candidiasis, Invasive · Phase 3
- Fungemia · Phase 3
- Infections · Phase 3
- Invasive Fungal Infections · Phase 1
- Liver Transplantation · Phase 3
- Mycoses · Phase 3
- Mycosis Fungoides · Phase 3
- Pneumocystis · Phase 3
- Pneumonia, Pneumocystis · Phase 2
- Sepsis · Phase 1
Mechanism of action
- Glucan synthaseINHIBITOR
GSL2 inhibitor
- CandidaINHIBITOR
Candida inhibitor
Approval history
- approvedPriority reviewFast trackMar 22, 2023
Chemistry & pharmacology
Loading structure…
SMILES
CC(=O)[O-].CCCCCOc1ccc(-c2ccc(-c3ccc(C(=O)N[C@H]4C[C@@H](O)[C@@H](OCC[N+](C)(C)C)NC(=O)[C@@H]5[C@@H](O)[C@@H](C)CN5C(=O)[C@H]([C@@H](C)O)NC(=O)[C@H]([C@H](O)[C@@H](O)c5ccc(O)cc5)NC(=O)[C@@H]5C[C@@H](O)CN5C(=O)[C@H]([C@@H](C)O)NC4=O)cc3)cc2)cc1- Mol. weight
- 1285.46 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL3989945 ↗
- ChEMBLCHEMBL3989928 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06774144 | Phase 3 | Oct 15, 2025 | Melinta Therapeutics, University of Pittsburgh |
| NCT06985758 | Phase 4 | Sep 30, 2025 | Universidad Complutense de Madrid |
| NCT06794554 | Phase 2 | Mar 1, 2025 | Mundipharma |
| NCT06329518 | Phase 1 | Jul 1, 2024 | Melinta Therapeutics, University of Connecticut |
| NCT05835479 | Phase 2 | Oct 31, 2023 | Mundipharma |
| NCT05534529 | Phase 1 | Feb 1, 2023 | Mundipharma |
| NCT04368559 | Phase 3 | May 31, 2020 | Cidara Therapeutics |
| NCT04117607 | Phase 1 | Oct 3, 2019 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT03667690 | Phase 3 | Oct 31, 2018 | Cidara Therapeutics |
Showing 9 of 9 trials
Page 1 / 1
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Mundipharma | For profit | 3 | 3 | 2 | 2023 |
| Cidara Therapeutics | For profit | 2 | 2 | 1 | 2018 |
| Melinta Therapeutics | For profit | 2 | 0 | 2 | 2024 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 1 | 1 | 1 | 2019 |
| Universidad Complutense de Madrid | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of Connecticut | Academic/Hospital | 1 | 1 | 1 | 2024 |
| University of Pittsburgh | Academic/Hospital | 1 | 1 | 1 | 2025 |
7 organizations
Page 1 / 1
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Cidara Therapeutics | For profit | MKTG | Mar 22, 2023 |
| Cidara Therapeutics | For profit | NDA2 | Mar 22, 2023 |
| Cidara Therapeutics | For profit | NDA | Mar 22, 2023 |
| Mundipharma | For profit | MKTG | Mar 22, 2023 |