In a major turning point against drug-resistant gonorrhoea, the first new antibiotics for the sexually transmitted infection in decades have been approved by the US Food and Drug Administration, offering renewed hope as global cases surge.
Researchers and global health officials say the approvals come at a critical moment, with gonorrhoea infecting more than 82 million people worldwide every year and drug-resistant strains spreading rapidly. The World Health Organization (WHO) has classified the bacterium as a “priority pathogen” due to its growing resistance to existing treatments.
According to WHO surveillance data, resistance to commonly used antibiotics such as ceftriaxone and cefixime rose sharply between 2022 and 2024, from 0.8% to 5% and from 1.7% to 11% respectively. During the same period, cases reached record highs in several regions, including England, while rates across Europe in 2023 were three times higher than in 2014.
One of the newly approved drugs, zoliflodacin (brand name Nuzolvence), received FDA approval on December 12.
The oral, single-dose treatment is designed specifically for gonorrhoea and is expected to slow the development of resistance through targeted use. Another antibiotic, gepotidacin, developed by GSK and already used for urinary tract infections, was approved a day earlier after proving effective against resistant gonorrhoea strains.
Dr Tereza Kasaeva, director of the WHO’s sexually transmitted infections department, called the approvals “an important and timely development” given the rising incidence of gonorrhoea, increasing antimicrobial resistance, and the lack of effective treatment options.
Zoliflodacin was developed through a not-for-profit collaboration between the Global Antibiotic Research & Development Partnership (GARDP) and pharmaceutical company Innoviva.
In clinical trial results published recently in The Lancet, the drug cured more than 90% of genital gonorrhoea infections, matching the effectiveness of current standard therapy, which involves an antibiotic injection followed by oral medication. No serious safety concerns were reported.
The trial involved 930 participants across Belgium, the Netherlands, South Africa, Thailand, and the United States. Under the partnership agreement, GARDP holds rights to register and commercialise the drug in low-income countries, most middle-income nations, and select high-income countries.
Calling the approval a “huge turning point,” GARDP executive director Dr Manica Balasegaram said drug-resistant gonorrhoea had long been outpacing antibiotic development. Clinicians on the ground echoed this view. Dr Rossaphorn Kittiyaowamarn, who led the Thailand trial, said a single-dose oral treatment could be a “game-changer” in reducing disease burden and preventing the global spread of highly resistant strains.
Health experts say the new antibiotics could reshape gonorrhoea control strategies worldwide, provided they are used carefully to preserve their effectiveness.