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# GSK Plans NDA for Antibiotic Gepotidacin
- URL: https://www.fdaweb.com/gsk-plans-nda-for-antibiotic-gepotidacin/
- Published: 2023-04-17T12:00:00.000Z
- Updated: 2026-09-14T18:25:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154225

GSK says it will submit an NDA by 6/30 for antibiotic gepotidacin and its use in treating uncomplicated urinary tract infections (uUTI) in female adults and adolescents. The submission will be based on “positive results” from the pivotal EAGLE-2 and EAGLE-3 Phase 3 trials that were stopped early for efficacy late last year based on a recommendation from an independent data monitoring committee, the company says.

In the studies, “gepotidacin demonstrated non-inferiority to nitrofurantoin, an existing first-line treatment for uUTI, in patients with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin,” GSK says. “Additionally, in the EAGLE-3 phase 3 trial, gepotidacin demonstrated statistically significant superiority versus nitrofurantoin.” The most common reported adverse events in patients taking gepotidacin were gastrointestinal-related.

GSK describes gepotidacin as a first-in-class triazaacenaphthylene antibiotic that “inhibits bacterial DNA replication by a novel mechanism of action and binding site and provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most strains of target uropathogens, such as *E. coli* and *Staphylococcus saprophyticus*, including isolates resistant to current antibiotics.”