ozenoxacin
Trade name: xepi
Approved
Dec 11, 2017
Ozenoxacin is an experimental quinolone antibiotic being developed for the treatment of impetigo and other dermatological bacterial infections. Ozenoxacin is active against some bacteria that have developed resistance to currently used quinolone and fluoroquinolone antibiotics. In two phase 3 studies, Ozenoxacin cream, 1%, applied topically twice daily for 5 days vs. placebo, demonstrated superiority on both clinical and bacteriological endpoints, according to the release. Superior bacteriological cure of Ozenoxacin compared to placebo was demonstrated as early as day 4. In both adults and a pediatric population aged 2 months and older, Ozenoxacin treatment was reported to be safe and well tolerated. — NCATS
Clinical trial activity
3 trials · 1 clinical orgs · 2 marketing orgs
Earliest trial started Sep 1, 2009 (NCT01005771)
Timeline
2000s
- Jan 1, 2009
Ferrer Internacional S.A. — Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2012
Ferrer Internacional S.A. — Earliest Phase 3 Sponsor(trial)
- Dec 11, 2017
Ferrer Internacional S.A. — Earliest FDA Approval
- Dec 11, 2017
Ferrer Internacional S.A. — NDA Secondary Org
- Dec 11, 2017
Ferrer Internacional S.A. — NDA Organization
- Dec 11, 2017
Ligand Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
Mechanism of action
- DNA topoisomerase IVINHIBITOR
DNA topoisomerase IV inhibitor
- DNA gyraseINHIBITOR
DNA gyrase inhibitor
- Topoisomerase IVINHIBITOR
Topoisomerase IV inhibitor
- DNA gyraseINHIBITOR
DNA gyrase inhibitor
Approval history
- approvedDec 11, 2017
Chemistry & pharmacology
SMILES
CNc1ncc(-c2ccc3c(=O)c(C(=O)O)cn(C4CC4)c3c2C)cc1C- Mol. weight
- 363.42 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Discontinued
Oral
No
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL3990047 ↗
- WikipediaOzenoxacin ↗
- NCATSV0LH498RFO ↗
Also known as
- 1-cyclopropyl-8-methyl-7-(5-methyl-6-(methylamino)-3-pyridinyl)-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid
- gf-001001-00
- ozenoxacin
- ozenoxacin
- ozenoxacin
- ozenoxacin
- ozenoxacin
- ozenoxacin
- ozenoxacin
- ozenoxacin
- t 3912
- t-3912
- zebiax
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02090764 | Phase 3 | Jun 1, 2014 | Ferrer Internacional S.A. |
| NCT01397461 | Phase 3 | Mar 1, 2012 | Ferrer Internacional S.A. |
| NCT01005771 | Phase 2 | Sep 1, 2009 | Ferrer Internacional S.A. |
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Ferrer Internacional S.A. | For profit | 3 | 3 | 2 | 2009 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Ferrer Internacional S.A. | For profit | NDA2 | Dec 11, 2017 |
| Ferrer Internacional S.A. | For profit | NDA | Dec 11, 2017 |
| Ligand Pharmaceuticals | For profit | MKTG | Dec 11, 2017 |