A single-dose oral medication called zoliflodacin shows promise as a new treatment for antibiotic-resistant gonorrhoea, according to a phase 3 clinical 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.
Gonorrhoea 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 gonorrhoea treatment more accessible worldwide.
The international trial involved more than 900 people from five countries (USA, South Africa, Thailand, Belgium, and the Netherlands). Participants received either the new pill or the standard treatment. Results showed 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.
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For Article: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01953-1/fulltext
For linked Comment: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02331-1/fulltext
Journal
The Lancet
Method of Research
Randomized controlled/clinical trial
Subject of Research
People
Article Title
Zoliflodacin versus ceftriaxone plus azithromycin for treatment of uncomplicated urogenital gonorrhoea: an international, randomised, controlled, open-label, phase 3, non-inferiority clinical trial
Article Publication Date
11-Dec-2025
COI Statement
The institutions or affiliated institutions of LAB, TAB, SEC, SD-M, HJCdV, JAD, KG, CK, RK, VN, NP, ES, SNT, and ZZ received funding from GARDP for the trial. Additionally, LAB has received investigatorinitiated research support from Hologic (donation of test kits) and SpeeDx for trials unrelated to this study. SNT received institutional research funding from GlaxoSmithKline, Entasis Therapeutics, and Innoviva Specialty Therapeutics. NP has received research funding to their institution from Gilead Sciences and ViiV Healthcare. SEC has received test kits from Cepheid and Hologic for trials unrelated to this study. AL, SO, and MB are employees of GARDP. SS is a former employee of Entasis Therapeutics and of GARDP. HB is an employee of Plus-Project, consulting for GARDP. DL is an employee of Innoviva Specialty Therapeutics and owns stock. JPM is a former employee of Entasis-Innoviva Specialty Therapeutics. JPO is a former employee of Entasis-Innoviva Specialty Therapeutics and owns stock. EWH has received consulting fees from GARDP and Visby Medical. All other authors report no competing interests.