FDA

FDA OKs single-dose oral antibiotic for uncomplicated urogenital gonorrhea

December 16, 2025

Brand name: Nuzolvence

Generic name: zoliflodacin

Manufacturer: Innoviva Specialty Therapeutics

Approval date: December 12, 2025

FDA has approved Nuzolvence (zoliflodacin), a spiropyrimidinetrione bacterial type II topoisomerase inhibitor, for the treatment of uncomplicated urogenital gonorrhea in adults and children ≥12 years of age who weigh at least 35 kg.

Efficacy

A randomized clinical trial evaluated the efficacy of Nuzolvence in 930 patients with uncomplicated urogenital gonorrhea. Approximately two-thirds of participants received a single 3-gram oral dose of Nuzolvence dissolved in water, while the remaining third received the standard regimen of IM ceftriaxone plus PO azithromycin. Treatment success was assessed by bacterial clearance 4 to 8 days post-therapy. Results demonstrated cure rates of 91% in the Nuzolvence group and 96% in the standard-treatment group, indicating that Nuzolvence achieved comparable effectiveness to the current standard of care.

Safety

The most common adverse effects reported in the study were low WBC counts, headache, dizziness, nausea, and diarrhea. Preclinical studies indicate that this agent may be associated with teratogenic effects, pregnancy loss, and potential impairment of male fertility

Sources:

FDA Approves Two Oral Therapies to Treat Gonorrhea. [News release]. 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-two-oral-therapies-treat-gonorrhea

U.S. FDA Approves Nuzolvence^® (zoliflodacin), a First-in-Class, Single-dose, Oral Antibiotic for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults. [News release]. 2025. https://investor.inva.com/news-releases/news-release-details/us-fda-approves-nuzolvencer-zoliflodacin-first-class-single-dose

Luckey A, et al. (2025, December 11). Lancet. Zoliflodacin versus ceftriaxone plus azithromycin for treatment of uncomplicated urogenital gonorrhoea: an international, randomised, controlled, open-label, phase 3, non-inferiority clinical trial. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01953-1/fulltext