Zoliflodacin: First Approval

Drugs. 2026 Jun;86(6):963-970. doi: 10.1007/s40265-026-02308-y. Epub 2026 Apr 20.

Abstract

Zoliflodacin (NUZOLVENCE®), a first-in-class, single-dose, oral spiropyrimidinetrione bacterial type II topoisomerase inhibitor, has been developed by Innoviva Specialty Therapeutics in collaboration with the Global Antibiotic Research and Development Partnership (GARDP) and the U.S. National Institute of Allergy and Infectious Diseases (NIAID) for the treatment of uncomplicated urogenital gonorrhea (uUGC). In December 2025, zoliflodacin was approved by the US FDA for the treatment of uUGC due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older weighing at least 35 kg. This article summarizes the milestones in the development of zoliflodacin leading to this first approval for the treatment of uUGC.

Publication types

  • Review

MeSH terms

  • Adult
  • Anti-Bacterial Agents* / administration & dosage
  • Anti-Bacterial Agents* / pharmacology
  • Anti-Bacterial Agents* / therapeutic use
  • Barbiturates* / administration & dosage
  • Barbiturates* / pharmacology
  • Barbiturates* / therapeutic use
  • Child
  • Drug Approval
  • Gonorrhea* / drug therapy
  • Humans
  • Isoxazoles
  • Morpholines
  • Neisseria gonorrhoeae / drug effects
  • Oxazolidinones
  • Spiro Compounds
  • Thiohydantoins* / administration & dosage
  • Thiohydantoins* / pharmacology
  • Thiohydantoins* / therapeutic use
  • Topoisomerase II Inhibitors* / administration & dosage
  • Topoisomerase II Inhibitors* / pharmacology
  • Topoisomerase II Inhibitors* / therapeutic use
  • United States
  • United States Food and Drug Administration

Substances

  • Anti-Bacterial Agents
  • zoliflodacin
  • Barbiturates
  • Topoisomerase II Inhibitors
  • Thiohydantoins
  • Isoxazoles
  • Morpholines
  • Spiro Compounds
  • Oxazolidinones