Ozenoxacin
As of the edition of 20 October 2026, Ozenoxacin is a small molecule: marketed, first approved in 2015 (JP).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Xepi
- First approved
- 28 September 2015 (JP)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Lnhc; 3 holders in all
- Registered trials
- 3, 0 stopped early
- Disease areas
- Infections; Skin and connective tissue
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 2 | 2 | 0 | 0 |
| All trials | 3 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ferrer Internacional | Applicant and Lead sponsor of trials | 2009 to now |
| Maruho | Applicant | 2015 to now |
| Lnhc | Acquired holder | 2026 to now |