GSK has received US FDA approval for a supplemental New Drug Application for gepotidacin, an oral antibiotic for uncomplicated urogenital gonorrhoea. The approval covers adults and adolescents aged 12 years and older, weighing at least 45 kg, who have limited or no alternative treatment options.
This marks a major step forward for gonorrhoea care in the US, where treatment options remain limited.
Gonorrhoea is one of the most common sexually transmitted infections worldwide.
In the US alone, over 600,000 cases were reported in 2023, according to the CDC.
Key challenges include:
An effective oral option could significantly improve access and adherence.
Gepotidacin is a first-in-class, oral antibiotic developed by GSK. It works through a novel mechanism, inhibiting bacterial DNA replication at a unique binding site.
Key features include:
It is the first new antibiotic class for gonorrhoea in over 30 years.
The FDA decision was supported by data from the EAGLE-1 Phase III trial.
Trial highlights:
These results confirmed both efficacy and tolerability.
Earlier this year, the FDA approved gepotidacin for:
With this latest approval, gepotidacin expands into sexually transmitted infections, strengthening its clinical relevance.
Health authorities, including the WHO and CDC, classify gonorrhoea as a priority public health threat. Resistance to current antibiotics continues to rise.
According to GSK’s Chief Scientific Officer Tony Wood:
Gepotidacin’s balanced enzyme inhibition makes resistance less likely from single mutations.
With FDA approval secured, gepotidacin is now available in the US for:
The drug’s development was partially funded by US federal agencies, reflecting its importance to public health preparedness.
Gepotidacin introduces a long-awaited oral alternative for gonorrhoea treatment.
It combines clinical efficacy, patient convenience, and a novel mechanism to tackle antibiotic resistance.
For infectious disease care, this approval is a meaningful and overdue upgrade.