What Was Approved?
On December 12, 2025, the U.S. Food and Drug Administration approved Nuzolvence (zoliflodacin) for the treatment of uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae in:
- Adults
- Pediatric patients 12 years of age and older
- Patients weighing at least 35 kg (about 77 pounds)
Nuzolvence is not approved as a general treatment for every type or location of gonorrhea infection.
How Does Nuzolvence Work?
Nuzolvence is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor.
It interferes with bacterial enzymes needed for DNA replication, which helps stop susceptible N. gonorrhoeae bacteria from multiplying.
How Is Nuzolvence Taken?
Nuzolvence is supplied as granules that are mixed with water and taken by mouth as a single dose.
In the phase 3 study supporting approval, patients received a single 3-gram oral dose of zoliflodacin.
Patients should follow the exact preparation and administration instructions provided with the prescription.
What Did the Clinical Trial Show?
FDA approval was supported by a phase 3 trial involving 930 adults and adolescents with uncomplicated gonorrhea.
Among patients included in the main efficacy analysis, microbiological cure at the urogenital site occurred in:
- 90.9% of patients receiving Nuzolvence
- 96.2% of patients receiving ceftriaxone plus azithromycin
The study was designed as a noninferiority trial, and the results supported FDA approval.
Why Is Antibiotic Stewardship Important?
Nuzolvence should be used only for infections that are proven or strongly suspected to be caused by susceptible bacteria.
Using antibacterial medicines when they are not needed can contribute to the development of drug-resistant bacteria.
Bottom Line
Nuzolvence (zoliflodacin) is an FDA-approved single-dose oral treatment for uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae in adults and eligible adolescents age 12 and older who weigh at least 35 kg.
Because gonorrhea treatment depends on the site of infection, susceptibility, and individual clinical factors, diagnosis and treatment should be guided by an appropriate healthcare professional.
Sources
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Nuzolvence.
- U.S. Food and Drug Administration (FDA) — FDA Approves Two Oral Therapies to Treat Gonorrhea, December 12, 2025.
- U.S. Food and Drug Administration (FDA) — Nuzolvence Approval Letter, December 2025.