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New single-dose gonorrhoea drug could be breakthrough for antibiotic-resistant infections

Zoliflodacin, the first new antibiotic developed exclusively for the treatment of this infection in decades, aims to fight drug-resistant superbugs.
Zoliflodacin, the first new antibiotic developed exclusively for the treatment of this infection in decades, aims to fight drug-resistant superbugs. Copyright  Cleared
Copyright Cleared
By Marta Iraola Iribarren
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A new single-dose treatment for gonorrhoea, expected to be approved in the coming days, could be the key to tackling the infection amid rising antibiotic resistance.

Gonorrhoea, a common sexually transmitted infection (STI) that often doesn't come with symptoms, has become harder to treat as bacteria develop resistance to existing antibiotics. If left untreated, it can cause serious problems such as pelvic inflammatory disease or infertility.

Zoliflodacin, the first new antibiotic developed exclusively for the treatment of this infection in decades, aims to fight drug-resistant superbugs and it is expected to receive marketing approval in the United States.

Researchers recently conducted a clinical trial involving more than 900 people from the US, South Africa, Thailand, Belgium, and the Netherlands – the largest evaluation to date in participants with N. gonorrhoeae infection.

The trial findings, published on Friday in The Lancet medical journal, saw that the new treatment – a single pill – cured over 90 per cent of infections at genital sites.

Researchers said that the new medication was well-tolerated among the participants, with side effects similar to those seen with current treatments, and no serious safety issues were reported.

“Gonorrhoea continues to be a significant public health concern worldwide, and the growing challenge of antimicrobial resistance only heightens the urgency for new treatment options,” said Edward Hook, professor of medicine at the University of Alabama and lead of the study.

He added that the decades-long absence of new gonorrhoea treatments, together with rising antibiotic resistance, has created significant challenges in managing this STI.

In 2023, there were around 100,000 confirmed gonorrhoea cases in the European Union, equivalent to 25 cases for every 100,000 people – a 31 per cent increase from the previous year.

Rising antibiotic resistance

The current main treatment is ceftriaxone, as the infection has grown resistant to every other known antibiotic that could fight it.

According to the European Centre for Disease Prevention and Control (ECDC), resistance to ceftriaxone remains uncommon in the EU. However, resistance to azithromycin – often given together with ceftriaxone – has risen in recent years, with 25.6 per cent of bacteria samples showing resistance in 2022.

The new treatment was developed through a public–private partnership led by Innoviva Speciality Therapeutics and the non-profit Global Antibiotic Research & Development Partnership (GARDP).

The US Food and Drug Administration (FDA) is expected to give approval for Zoliflodacin in the coming days.

In the EU, it is still an investigational drug, used only in clinical trials or under national early‑access frameworks, not as a routinely prescribed antibiotic.

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