FDA Approves Zoliflodacin (Nuzolvence) Granules for Uncomplicated Urogenital Gonorrhea

The US Food and Drug Administration (FDA) approved Innoviva Specialty Therapeutics’ zoliflodacin (Nuzolvence) granules for the treatment of uncomplicated urogenital gonorrhea in adults and children ≥ 12 years of age who weigh > 35 kg.1

The approval builds on a December 11, 2025, approval granted to GSK for gepotidacin (Blujepa) oral tablets for adult and pediatric patients ≥ 12 years of age weighing ≥ 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhoea caused by susceptible strains of Neisseria gonorrhoeae.2

“These approvals mark a significant milestone for treatment options for patients with uncomplicated urogenital gonorrhea,” said Adam Sherwat, MD, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.1

Zoliflodacin is a spiropyrimidinetrione antibacterial that inhibits type II topoisomerase, an enzyme essential for bacterial replication. Its novel mechanism offers an alternative to current antibiotics, addressing growing concerns about gonococcal resistance.

The approval was based on phase 3 study data which compared a single oral 3g dose of zoliflodacin with intramuscular ceftriaxone 500mg plus oral azithromycin 1g. The primary endpoint was microbiological response at the urogenital site at the Test-of-Cure visit, 6 ± 2 days after treatment. Secondary analyses included microbiological cure at rectal or pharyngeal sites and safety outcomes.3,4

In November 2023, the phase 3 zoliflodacin trial met its primary endpoint, demonstrating statistical non-inferiority in microbiological cure at the urogenital site compared with the current global standard of care, intramuscular ceftriaxone plus oral azithromycin. The FDA granted Priority Review for zoliflodacin’s New Drug Application in June 2025.3

Investigators observed that zoliflodacin demonstrated non-inferiority to ceftriaxone plus azithromycin. In the micro-intent-to-treat (micro-ITT) population (n=744), zoliflodacin achieved a microbiological cure rate of 90.9%, a 5.3% difference compared to ceftriaxone and azithromycin, which achieved a 96.2% cure rate (95% Confidence Interval [CI], 1.4%-8.7%). Microbiological cure rates at extragenital sites were comparable between treatment arms.3,4

Zoliflodacin was generally well tolerated, and the incidence of treatment-emergent adverse events was similar between the zoliflodacin and comparison groups (46.2% vs 46.4%). Investigators did not report any deaths or other serious adverse events.3,4

References

1. FDA. FDA Approves Two Oral Therapies to Treat Gonorrhea. December 12, 2025. Accessed December 12, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-two-oral-therapies-treat-gonorrhea

2. Smith T. FDA Approves Gepotidacin as Oral Treatment of Uncomplicated Urogential Gonorrhea. HCPLive. December 11, 2025. Accessed December 12, 2025. https://www.hcplive.com/view/fda-approves-gepotidacin-oral-treatment-uncomplicated-urogential-gonorrhea

3. Investor Relations - FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025 - Innoviva. Innoviva, Inc. Published 2025. Accessed December 10, 2025. https://investor.inva.com/news-releases/news-release-details/fda-grants-priority-review-zoliflodacin-new-drug-application

4. ‌Investor Relations - Innoviva Specialty Therapeutics’ Positive Phase 3 Oral Zoliflodacin Data for the Treatment of Uncomplicated Gonorrhea Announced at ESCMID Global 2024 - Innoviva. Innoviva, Inc. Published 2024. Accessed December 10, 2025. https://innovivainc.gcs-web.com/news-releases/news-release-details/innoviva-specialty-therapeutics-positive-phase-3-oral