The first new treatments for gonorrhoea in decades could be a “huge turning point” in efforts to combat the rise of superbug strains of the bacteria, researchers have said.
Gonorrhoea is on the rise around the world, with more than 82m infections globally each year and particularly high rates in Africa and countries in the World Health Organization’s Western Pacific region, which reaches from Mongolia and China to New Zealand. Cases in England are at a record high, and rates in Europe were three times higher in 2023 than in 2014.
Health officials are concerned about an increase in drug-resistant strains of the bacterium, with the WHO designating it a “priority pathogen”. A WHO surveillance programme found resistance to the primary antibiotics used to treat gonorrhoea, ceftriaxone and cefixime, had risen sharply from 0.8% to 5% and from 1.7% to 11% respectively between 2022 and 2024.
Zoliflodacin is one of two new treatments for the sexually transmitted infection to receive regulatory approval in the past week.
Dr Tereza Kasaeva, director of the WHO’s sexually transmitted infections department, said: “The approval of new treatments for gonorrhoea is an important and timely development in the context of rising global incidence, increasing antimicrobial resistance and the very limited therapeutic options currently available.”
Zoliflodacin, also known by the brand name Nuzolvence, was approved by the US Food and Drug Administration on 12 December for use against gonorrhoea, which can cause serious health problems, including infertility. Scientists hope that targeted use against the infection will slow the development of resistance.
Gepotidacin, an antibiotic developed by the pharmaceutical company GSK that is also used to treat urinary tract infections, was also approved on 11 December after it was shown in trials to work against drug-resistant strains of gonorrhoea.
Zoliflodacin emerged from a new, not-for-profit approach for antibiotic development, in which the non-profit organisation Global Antibiotic Research & Development Partnership (GARDP) collaborated with the pharmaceutical company Innoviva.
Dr Manica Balasegaram, executive director of GARDP, said: “This approval marks a huge turning point in the treatment of multidrug-resistant gonorrhoea, which until now has been outpacing antibiotic development.”
In results published in the Lancet last week, zoliflodacin cured more than 90% of genital gonorrhoea infections, putting it on an equal footing with current standard treatment, which combines two antibiotics: an injection of ceftriaxone followed by an oral dose of azithromycin. No serious safety issues were reported.
The trial of the drug, which is part of a new class of antibiotics called spiropyrimidinetriones, involved 930 participants from Belgium, the Netherlands, South Africa, Thailand and the US.
Under the terms of its partnership, GARDP has the right to register and commercialise it in all low-income countries, most middle-income countries, and several high-income countries.
Dr Rossaphorn Kittiyaowamarn, principal investigator of the trial in Thailand, said: “As clinicians, we see the devastating impact drug-resistant gonorrhoea can have on people’s lives in Thailand.
Having a single-dose, oral treatment like this will be a game-changer for gonorrhoea control. This is essential to reduce the burden of disease for individuals and to prevent the spread of highly drug-resistant gonorrhoea globally.”
