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**Zoliflodacin** is a first-in-class, single-dose oral **spiropyrimidinetrione** antibiotic developed by **Innoviva Specialty Therapeutics** in collaboration with **GARDP** for the treatment of **uncomplicated urogenital gonorrhea caused by *Neisseria gonorrhoeae***. It acts by inhibiting bacterial type II topoisomerases, with **DNA gyrase as the primary target** and **topoisomerase IV as a secondary target**, stabilizing DNA cleavage complexes and producing a bactericidal effect. The drug emerged from the Entasis portfolio acquired by Innoviva, was evaluated in a global pivotal Phase 3 non-inferiority trial, and has been publicly verified through ClinicalTrials.gov, peer-reviewed publications, sponsor materials, and FDA approval materials. In the United States it is marketed as **NUZOLVENCE** as an oral suspension administered as a **single 3 g oral dose** for eligible adults and adolescents.
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