A single-dose oral medication called zoliflodacin shows promise as a new treatment for antibiotic-resistant gonorrhea, according to a Phase III trial published in The Lancet.
The study found that one dose of zoliflodacin was as effective as the current standard treatment, which combines two antibiotics: an injection of ceftriaxone followed by an oral dose of azithromycin.
Gonorrhea is one of the most common sexually transmitted infections, affecting over 82 million people globally each year. However, it is increasingly difficult to treat as the bacteria that cause infection develop resistance to current antibiotics. This new medication has the potential to help slow the spread of antibiotic-resistant bacteria and make gonorrhea treatment more accessible worldwide.
The international trial involved more than 900 people from five countries (U.S., South Africa, Thailand, Belgium, and the Netherlands). Participants received either the new pill or the standard treatment.
Results show that zoliflodacin cured over 90% of infections at genital sites. The medication was well tolerated, with side effects similar to those seen with current treatments, and no serious safety issues were reported.
Zoliflodacin is currently awaiting approval from the U.S. Food and Drug Administration (FDA). If approved, the authors say it could greatly improve global efforts to control drug-resistant gonorrhea infections, support community-led care, and protect reproductive health for millions of people.
More information
Zoliflodacin versus ceftriaxone plus azithromycin for treatment of uncomplicated urogenital gonorrhoea: an international, randomised, controlled, open-label, phase 3, non-inferiority clinical trial, The Lancet (2025). DOI: 10.1016/S0140-6736(25)01953-1
Journal information:
The Lancet
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