Ibrexafungerp
As of the edition of 20 October 2026, Ibrexafungerp is a small molecule: marketed, first approved in 2021 (US); US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Brexafemme
- First approved
- 1 June 2021 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- GSK
- Registered trials
- 14, 2 stopped early
- Disease areas
- Infections; Pregnancy and women's health; Urinary and reproductive; Lungs and airways; Immune system; Mouth and teeth
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. The application that gives this date is held by GSK.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product5 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 4 | 3 | 0 | 1 |
| Phase 3 | 7 | 6 | 0 | 1 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Scynexis | Originator and Lead sponsor of trials | 2014 to now |
| GSK | Acquired holder | 2025 to now |