New antibiotic zoliflodacin targets drug-resistant gonorrhoea

A new oral antibiotic called zoliflodacin has shown effectiveness in treating gonorrhoea, clearing 91 percent of infections in a clinical trial. The drug offers a potential alternative to the increasingly resistant standard treatment of ceftriaxone. With resistance to existing antibiotics rising globally, this development could help delay the emergence of untreatable strains.

Gonorrhoea, caused by the bacterium Neisseria gonorrhoeae, infects more than 80 million people worldwide each year. The infection, which spreads through sexual contact, often leads to symptoms like burning during urination and abnormal discharge from the genitals. Untreated cases can result in infertility and complications during pregnancy.

Standard treatment relies on injectable ceftriaxone, but resistance is growing. According to the World Health Organization, about 5 percent of cases in 12 countries—including Thailand, South Africa, and Brazil—were resistant to ceftriaxone in 2024, a sixfold rise from 2022. "We are running out of options," noted Alison Luckey from the Global Antibiotic Research and Development Partnership, highlighting the decades-long gap since the last new gonorrhoea drug approval.

To address this, researchers tested zoliflodacin on 744 patients across the US, South Africa, Thailand, Belgium, and the Netherlands. Participants received either zoliflodacin or the standard combination of ceftriaxone and azithromycin. After six days, swabs showed zoliflodacin cleared 91 percent of infections, compared to 96 percent for the standard therapy—a difference deemed insignificant. Both treatments caused similar mild, temporary side effects like headaches and nausea.

While most trial cases involved non-resistant strains, lab tests confirm zoliflodacin works against bacteria resistant to all common antibiotics. As an oral option, it may appeal more than injections, which some avoid due to needle phobia. Luckey suggested its use as a first-line treatment in high-resistance areas.

The team has submitted data to the US Food and Drug Administration, expecting a decision on December 15. Approvals in the UK, Europe, and Asia could follow, per Charlotte-Eve Short of Imperial College London. Combined with the recent UK rollout of the meningitis B vaccine for gonorrhoea prevention, these advances—alongside the pending approval of gepotidacin—signal progress against antimicrobial resistance. "This is great news," Short said, emphasizing the dual approach of prevention and treatment.

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Photorealistic image of zoliflodacin antibiotic pill next to The Lancet journal reporting successful phase 3 trial results for gonorrhea treatment.
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Lancet reports phase 3 results for single-dose oral zoliflodacin in uncomplicated gonorrhea

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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.

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