Zoliflodacin Noninferior for Uncomplicated Urogenital Gonorrhea
THURSDAY, Dec. 18, 2025 (HealthDay News) -- Zoliflodacin is noninferior to ceftriaxone plus azithromycin for the treatment of uncomplicated urogenital gonorrhea, according to a study published online Dec. 11 in The Lancet.
Alison Luckey, from the Global Antibiotic Research & Development Partnership in Geneva, and colleagues conducted a randomized, open-label, noninferiority clinical trial involving participants aged 12 years and older with clinical suspicion of uncomplicated urogenital gonorrhea. Eligible participants were randomly assigned to receive a single dose of zoliflodacin 3 g (oral) or ceftriaxone 500 mg (intramuscular) plus azithromycin 1 g (oral) (621 and 309, respectively).
The researchers found that microbiological cure rates at test of cure (day 6 ± 2) in the microbiological intention-to-treat population were 90.9 and 96.2 percent for zoliflodacin and comparator, respectively. The estimated between-group difference was 5.3 percent (95 percent confidence interval, 1.4 to 8.6), and the upper confidence interval limit was within the prespecified non-inferiority margin of <12 percent. Zoliflodacin was generally well tolerated, with similar adverse events between the groups. In the zoliflodacin group, the most frequently reported treatment-emergent adverse events were headache, neutropenia, and leukopenia (10, 7, and 4 percent, respectively), while in the comparator group they were injection site pain, neutropenia, and diarrhea (12, 8, and 7 percent, respectively).
"These data suggest a potential role for zoliflodacin as an effective oral treatment option for uncomplicated urogenital gonorrhea," the authors write.
Several authors disclosed ties to the biopharmaceutical industry.