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Single-Dose Pill Shows Promise Against Antibiotic-Resistant Gonorrhoea

In an international phase 3 trial, oral zoliflodacin showed a 90.9% cure rate for urogenital gonorrhea, comparable to 96.2% with standard injectable treatment, addressing rising antibiotic resistance.

  • On Thursday, an international phase III trial showed investigational oral zoliflodacin noninferior to intramuscular ceftriaxone plus oral azithromycin for uncomplicated urogenital gonorrhea, with a 90.9% cure rate among over 900 patients, Alison Luckey of the Global Antibiotic Research & Development Partnership reported.
  • Practical barriers to injectable ceftriaxone, such as clinics not stocking it, prompted the search for oral options, with WHO data showing about 5.3% ceftriaxone resistance across 12 countries in 2024.
  • Laboratory and trial surveillance found the trial cohort of 930 randomized patients met noninferiority metrics with a 5.3% estimated difference, upper CI 10.2%, and zoliflodacin resistance did not develop during the trial.
  • If regulators approve the drug, zoliflodacin could expand access, slow resistant infections, and protect reproductive health, with UK, Europe and Asia approvals probably following soon, says Charlotte-Eve Short at Imperial College London.
  • Researchers cautioned the open-label design and limited female and adolescent enrollment restrict generalizability, and urged enhanced global monitoring of gonococcal resistance due to rapid bacterial evolution.
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A single-dose oral drug called zoliflodacin is promising as a new treatment for antibiotic-resistant gonorrhea, according to a phase 3 clinical trial published by a team of international researchers from the United States, Europe, South Africa and Thailand, led by the University of Alabama at Birmingham, United States, at The Lancet. The study found that a dose of zoliflodacin was as effective as the current standard treatment, combining two ant…

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Science broke the news in on Thursday, December 11, 2025.
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