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<p>Zoliflodacin (NUZOLVENCE<sup>®</sup>), 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 <i>Neisseria gonorrhoeae</i> in adults and pediatric patients 12&#xa0;years of age and older weighing at least 35&#xa0;kg. This article summarizes the milestones in the development of zoliflodacin leading to this first approval for the treatment of uUGC.</p>

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Zoliflodacin: First Approval

  • 期刊论文

  • 发表日期：

    2026年4月20日

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  • Aisling McGuigan

摘要

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.