A new pill that combats antibiotic-resistant strains of gonorrhoea has inched closer to approval in the US, after the US Food and Drug Administration (FDA) accepted GSK鈥檚 gepotidacin for priority review.
A priority review expedites the FDA鈥檚 decision on a drug application, cutting review time down from 10 to six months. The agency has set a Prescription Drug User Fee Act (PDUFA) action date of 11 December 2025. If approved, it would be indicated for the treatment of uncomplicated urogenital gonorrhoea in patients aged 12 years and older who weigh at least 45kg.
Gepotidacin is already available in the US under the brand name Blujepa for the treatment of urinary tract infections (UTI) in women and girls aged 12 years and above, courtesy of an FDA approval in March 2025.
Currently, gonorrhoea treatment options in the US mostly rely on injectable drugs, such as Roche鈥檚 Rocephin (ceftriaxone). While there are oral antibiotics approved by the FDA, these are often broad-use drugs such as Pfizer鈥檚 Zithromax (azithromycin).
In a Phase III trial (NCT04010539) that enrolled than 600 adults and teenagers, gepotidacin was shown to successfully treat about 92% of patients when taken twice daily. This was of Rocephin and Zithromax, which had success rates of 91.2%.
There were also no failures at the urogenital site due to bacterial persistence arising from gonorrhoea, signifying gepotidacin鈥檚 important role against resistant strains.
US Tariffs are shifting - will you react or anticipate?
Don鈥檛 let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataData from the World Health Organization (WHO) shows a rise in the prevalence of multi-resistant gonorrhoea. As of 2023, out of 87 countries where enhanced gonorrhoea antimicrobial resistance surveillance was conducted, nine countries reported elevated levels of resistance to Rocephin. Antibiotic-resistant strains of gonorrhoea mean tackling its spread is harder at public health levels.
Developed by GSK but with funding from US infectious disease grants, Gepotidacin is a triazaacenaphthylene antibiotic that inhibits bacterial DNA replication. The drug inhibits two different Type II topoisomerase enzymes, which gives it activity against a range of pathogens that target the urinary system.
Another oral antibiotic could also be set to join gepotidacin in the US drug armoury against gonorrhoea. In June, the FDA accepted a new drug application for zoliflodacin, co-developed by Innoviva Specialty Therapeutics and Global Antibiotic Research & Development Partnership (GARDP). Zoliflodacin鈥檚 PDUFA date is assigned for 15 December 2025, four days later than that for gepotidacin.
A major milestone in the gonorrhoea treatment space occurred in the UK last week when the NHS rolled out free vaccines for those at high risk of infection. The GSK-developed 4CMenB vaccine is approved to prevent meningococcal B, but a UK vaccine committee recommended its off-label use to curb rising cases. It marks the first time in the world that a vaccine is being used to combat gonorrhoea.
