Zoliflodacin
As of the edition of 20 October 2026, Zoliflodacin is a small molecule: marketed, first approved in 2025 (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 2025
- Kind
- Small molecule
- Brand name
- Nuzolvence
- First approved
- 12 December 2025 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Entasis Therapeutics
- Registered trials
- 7, 0 stopped early
- Disease areas
- Infections; Urinary and reproductive
US protection
US protection ends in 2035.
The last listed US exclusivity ends in 2035. The application that gives this date is held by Entasis Therapeutics.
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.
See the exact date and the 5 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Entasis Therapeutics | Originator and Lead sponsor of trials | 2015 to now |