GSK's Gepotidacin Seeks Priority Review for Gonorrhoea Treatment

GSK shares opened higher after the US FDA accepted gepotidacin for priority review as a treatment for uncomplicated gonorrhoea. The new oral pill showed similar effectiveness to the standard injectable therapy in a phase III trial and could improve patient convenience and compliance. With over 600,000 cases reported in the US in 2023, gepotidacin offers a new alternative to address a significant unmet need for gonorrhoea. GSK shares opened 1% higher at 1,411.45p.

GSK plc (LON:GSK, NYSE: GSK) shares opened higher on Monday following the US Food and Drug Administration (FDA) accepting a supplemental New Drug Application (NDA) for gepotidacin, an oral treatment for uncomplicated urogenital gonorrhoea. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date in December 2025 [1].

The submission is supported by positive phase III data from the EAGLE 1 trial, demonstrating that gepotidacin, given as two doses of 3,000mg, is non-inferior to the current standard of care, which involves intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg) [2]. The success rates for both treatments were comparable, with gepotidacin achieving 92.6% efficacy compared to 91.2% for the standard therapy.

Gonorrhoea is a significant public health concern, with over 600,000 cases reported in the US in 2023. The disease is currently treated with injectable antibiotics, which may not be suitable or available for all patients [3]. The approval of gepotidacin could provide a much-needed oral alternative, improving patient convenience and compliance.

GSK's shares opened 1% higher at 1,411.45p following the announcement, reflecting investor optimism about the potential market opportunity and the company's ability to address a significant unmet medical need.

References:

[1] https://www.directorstalkinterviews.com/gsks-gepotidacin-receives-us-fda-priority-review-for-gonorrhoea-treatment/4121211372
[2] https://www.morningstar.com/news/dow-jones/20250811582/us-drug-regulator-to-consider-gsks-gepotidacin-as-gonorrhea-treatment