Results from a global phase 3 trial of zoliflodacin, an investigational single-dose oral antibiotic, were published in The Lancet in December 2025, showing the drug was non-inferior to a ceftriaxone-based standard regimen for curing uncomplicated urogenital gonorrhea in a study of 930 participants across five countries.
A phase 3 clinical trial of zoliflodacin—a first-in-class, single-dose oral antibiotic candidate for uncomplicated gonorrhea—has been published in The Lancet, adding peer-reviewed detail to earlier topline findings released in 2023 and subsequent conference presentations.
According to a ScienceDaily summary of the paper, the randomized study enrolled more than 900 participants across five countries: the United States, South Africa, Thailand, Belgium and the Netherlands. Participants received either zoliflodacin or a comparator regimen that includes an intramuscular injection of ceftriaxone plus an oral dose of azithromycin.
The report says the single-dose oral regimen cured more than 90% of genital infections and was generally well tolerated, with side effects similar to those seen with existing gonorrhea treatments and no serious safety concerns reported.
The Global Antibiotic Research & Development Partnership (GARDP) describes the trial as the largest ever conducted for a new gonorrhea treatment and says it involved 930 participants across 16 trial sites in the same five countries.
Zoliflodacin’s results come as public health agencies continue to warn about rising antimicrobial resistance in Neisseria gonorrhoeae, which has developed resistance to multiple antibiotic classes over time.
In the United States, zoliflodacin has been under Food and Drug Administration review following the submission of a New Drug Application by Innoviva Specialty Therapeutics and partners. The company has said the FDA granted Priority Review and set a target action date of December 15, 2025.
