Rezafungin
As of the edition of 20 October 2026, Rezafungin is a small molecule: marketed, first approved in 2023 (US); US protection ends in 2038.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Rezzayo
- First approved
- 22 March 2023 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- MUNDIPHARMA BRASIL PRODUTOS MÉDICOS E FARMACÊUTICOS LTDA; 2 holders in all
- Registered trials
- 13, 3 stopped early
- Disease areas
- Infections; Lungs and airways; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. The application that gives this date is held by Mundipharma.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 5 | 2 | 0 | 3 |
| Phase 2 | 4 | 2 | 2 | 0 |
| Phase 3 | 3 | 2 | 1 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Mundipharma | Acquired holder | 2024 to now |