In a significant breakthrough for global public health, the United States Food and Drug Administration (FDA) has approved the first new treatments for gonorrhoea in decades. This development arrives as the world grapples with a surge in cases of the sexually transmitted infection (STI) and growing fears over strains that are resistant to existing antibiotics.
A Global Health Crisis Intensifies
Gonorrhoea is a major and escalating global concern. The World Health Organization (WHO) estimates there are now more than 82 million new infections worldwide each year. Rates are particularly high in Africa and the WHO's Western Pacific region, which spans from China and Mongolia to New Zealand. In Europe, infection rates in 2023 were three times higher than they were in 2014, while cases in England have reached a record high.
The situation is made more urgent by the rapid rise of antimicrobial resistance. The WHO has classified drug-resistant gonorrhoea as a "priority pathogen." Its surveillance programme found that between 2022 and 2024, resistance to the primary antibiotics ceftriaxone and cefixime rose sharply from 0.8% to 5% and from 1.7% to 11%, respectively.
Two New Weapons in the Arsenal
The FDA approved two novel antibiotics within days of each other in December. Zoliflodacin, also known by the brand name Nuzolvence, was approved on 12 December. It is the first drug to emerge from a unique not-for-profit development model led by the Global Antibiotic Research & Development Partnership (GARDP) in collaboration with Innoviva.
Just one day earlier, on 11 December, the FDA also approved gepotidacin, an antibiotic developed by GSK that is also used to treat urinary tract infections. Clinical trials demonstrated its effectiveness against drug-resistant strains of the gonorrhoea bacteria.
Dr Tereza Kasaeva, director of the WHO's STI department, stated: "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."
A Potential 'Game-Changer' for Treatment
Researchers have hailed the approvals, particularly for zoliflodacin, as a potential turning point. Dr Manica Balasegaram, executive director of GARDP, called it a "huge turning point in the treatment of multidrug-resistant gonorrhoea, which until now has been outpacing antibiotic development."
Published results in the Lancet show that zoliflodacin, a single-dose oral antibiotic from a new class called spiropyrimidinetriones, cured over 90% of genital gonorrhoea infections. This puts it on par with the current standard treatment—an injection of ceftriaxone followed by oral azithromycin. The trial involved 930 participants across Belgium, the Netherlands, South Africa, Thailand, and the US, with no serious safety issues reported.
Dr Rossaphorn Kittiyaowamarn, a principal investigator in Thailand, emphasised the practical impact: "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." Under its partnership terms, GARDP holds the rights to register and commercialise zoliflodacin in many low- and middle-income countries.
The arrival of these new treatments offers a crucial new line of defence. However, health officials stress that targeted use and ongoing surveillance will be vital to slow the development of further resistance and to manage this persistent public health threat effectively.
