GSK gepotidacin edges closer to landmark approval for gonorrhoea
By Iain Gilbert
Date: Monday 11 Aug 2025
(Sharecast News) - Drugmaker GSK moved closer to expanding its antibiotic portfolio on Monday, after US regulators accepted its application to review gepotidacin as a potential oral treatment for gonorrhoea.
The FDA's priority review follows positive phase III data from the EAGLE-1 trial, which showed gepotidacin delivered a 92.6% success rate at the urogenital site, compared to 91.2% for the standard combination of intramuscular ceftriaxone and oral azithromycin.
If approved, GSK's gepotidacin would be the first oral option for treating uncomplicated urogenital gonorrhoea in patients aged 12 and over, offer a new option to US patients currently relying on injectable treatments. The FDA has set a decision date of 11 December under the Prescription Drug User Fee Act.
Review of regulatory submissions for the uncomplicated urinary tract infection indication was also ongoing in both the UK and Australia.
Reporting by Iain Gilbert at Sharecast.com
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