Gonococcal urethritis

Two months after its urogenital gonorrhea antibiotic hit the primary endpoint in a registrational trial, GSK is providing a closer look at results as it gears up for regulatory filings in 2025. The Phase 3 EAGLE-1 trial compared GSK’s antibiotic with standard-of-care ceftriaxone plus azithromycin in 600 people with uncomplicated urogenital gonorrhea. In the primary endpoint of microbiological response at the test-of-cure visit three to seven days after treatment, gepotidacin achieved a 92.6% success rate versus 91.2% for control, per a Wednesday release . The p-value of the non-inferiority endpoint was not disclosed. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

GSK’s oral antibiotic gepotidacin has hit the primary endpoint in a Phase III trial for urogenital gonorrhea, a growing public health concern due to increased rates and emerging resistance. The EAGLE-1 trial set gepotidacin against ceftriaxone plus azithromycin in around 600 subjects with uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae . The drug candidate demonstrated non-inferiority in the trial’s primary endpoint, microbiological response at the Test-of-Cure visit three to seven days after treatment. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.