The first new treatments for gonorrhoea in decades have been approved in the US, raising hopes of a breakthrough against increasingly drug-resistant strains of the sexually transmitted infection.
Gonorrhoea cases are surging worldwide, with an estimated 82 million infections each year. Rates are at record highs in England and have tripled across Europe since 2014. Health officials are alarmed by growing resistance to current frontline antibiotics, leading the World Health Organization to classify gonorrhoea as a priority pathogen.
Last week, the US Food and Drug Administration approved two new antibiotics. Zoliflodacin, marketed as Nuzolvence, was cleared on 12 December, followed a day earlier by approval of gepotidacin, developed by GSK. Both have shown effectiveness against drug-resistant strains.
WHO’s Dr Tereza Kasaeva said the approvals were “important and timely” given rising infections and dwindling treatment options. Resistance to existing drugs such as ceftriaxone and cefixime has increased sharply in recent years, according to WHO surveillance data.
Zoliflodacin, developed through a partnership between the non-profit Global Antibiotic Research & Development Partnership (GARDP) and Innoviva, cured more than 90% of genital gonorrhoea cases in clinical trials published in The Lancet. The trials involved 930 participants across Europe, Africa, Asia and the US, with no serious safety concerns reported.
Dr Manica Balasegaram, GARDP’s executive director, called the approval “a huge turning point”, noting that antibiotic development has struggled to keep pace with resistance.
Clinicians also highlighted the importance of zoliflodacin being a single-dose oral treatment. Dr Rossaphorn Kittiyaowamarn, who led trials in Thailand, said it could be a “game-changer” for controlling the disease and preventing the global spread of highly resistant gonorrhoea.
Experts caution that careful use will be essential to slow the emergence of resistance, but the approvals offer renewed optimism in tackling a growing public health threat.
