Treats uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae. Sold as Nuzolvence. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Zoliflodacin (sold as Nuzolvence), first approved Dec 12, 2025, with 0 new uses approved and 0 published complete response letters.
| Pharmacokinetics of Oral Zoliflodacin 3 g in Healthy Lactating WomenLactation · Global Antibiotics Research and Development Partnership | Phase 4 | Not yet recruiting | Nov 9, 2026 |
| Study to Evaluate the Effect of Zoliflodacin on Testicular Function in Healthy Adult MenTesticular Abnominalies · Global Antibiotics Research and Development Partnership | Phase 4 | Not yet recruiting | Jun 10, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 12, 2025 | NuzolvenceNDA 219491 · New molecular entity | Entasis Therap | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
