zoliflodacin
Approved
Dec 12, 2025
Zoliflodacin is an experimental antibiotic that is being studied for the treatment of antibiotic resistant Neisseria gonorrhoeae (gonorrhea). It has a novel mechanism of action which involves inhibition of bacterial type II topoisomerases. Zoliflodacin is being developed as part of a public-private partnership between Innoviva Specialty Therapeutics and the Global Antibiotic Research & Development Partnership (GARDP), and the drug has demonstrated clinical efficacy equivalent to ceftriaxone in Phase III clinical trials. — Wikipedia
Clinical trial activity
7 trials · 8 clinical orgs · 1 marketing orgs
Earliest trial started Nov 25, 2014 (NCT02257918)
Timeline
2010s
- Jan 1, 2014
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2015
Entasis Therapeutics — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2019
Earliest Phase 3 Sponsor(trial)
2020s
- Dec 12, 2025
Earliest FDA Approval
- Dec 12, 2025
Entasis Therapeutics — Marketing Organization
Indications
Approved for
Mechanism of action
- Gyrase BINHIBITOR
Q6S6F1 inhibitor
- Topoisomerase IVINHIBITOR
Topoisomerase IV inhibitor
- DNA gyraseINHIBITOR
DNA gyrase inhibitor
Approval history
- approvedPriority reviewDec 12, 2025
Chemistry & pharmacology
SMILES
C[C@@H]1CN2c3c(cc4c(N5C(=O)OC[C@@H]5C)noc4c3F)CC3(C(=O)NC(=O)NC3=O)[C@H]2[C@H](C)O1- Mol. weight
- 487.44 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaZoliflodacin ↗
- ChEMBLCHEMBL3544978 ↗
Also known as
- azd0914
- azd0914
- azd-0914
- azd-0914
- etx-0914
- etx-0914
- zoliflodacin
- zoliflodacin
- zoliflodacin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05635305 | Phase 1 | Nov 9, 2022 | Global Antibiotics Research and Development Partnership, KCAS Bio, Parexel |
| NCT03959527 | Phase 3 | Sep 30, 2019 | Global Antibiotics Research and Development Partnership |
| NCT03718806 | Phase 1 | Oct 3, 2018 | Drugs for Neglected Diseases Initiative, Quotient |
| NCT03613649 | Phase 1 | Aug 17, 2018 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT03404167 | Phase 1 | Feb 14, 2018 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT02298920 | Phase 1 | Jan 1, 2015 | Covance, Entasis Therapeutics |
| NCT02257918 | Phase 2 | Nov 25, 2014 | National Institute of Allergy and Infectious Diseases (NIAID) |
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 3 | 3 | 2 | 2014 |
| Global Antibiotics Research and Development Partnership | Academic/Hospital | 2 | 2 | 2 | 2019 |
| Covance | For profit | 1 | 0 | 1 | 2015 |
| Drugs for Neglected Diseases Initiative | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Entasis Therapeutics | For profit | 1 | 1 | 1 | 2015 |
| KCAS Bio | For profit | 1 | 0 | 1 | 2022 |
| Parexel | For profit | 1 | 0 | 1 | 2022 |
| Quotient | For profit | 1 | 0 | 1 | 2018 |
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Entasis Therapeutics | For profit | MKTG | Dec 12, 2025 |