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# GSK Stops UTI Trials and Opts for NDA
- URL: https://www.fdaweb.com/gsk-stops-uti-trials-and-opts-for-nda/
- Published: 2022-11-03T12:00:00.000Z
- Updated: 2026-09-14T18:05:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153122

GSK has stopped enrollment early due to positive results in two Phase 3 trials evaluating gepotidacin, an investigational drug for uncomplicated urinary tract infection (uUTI). The early stoppage comes on the recommendation of an independent data monitoring committee, which conducted a pre-specified interim analysis of efficacy and safety data in over 3,000 patients enrolled in the trials. The company says it will now file an NDA in the first half of 2023.

“The EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint of combined clinical and microbiological resolution following treatment at the Test-Of-Cure (TOC) visit for gepotidacin versus nitrofurantoin in patients with a confirmed uUTI and a uropathogen sensitive to nitrofurantoin,” GSK says. The data committee’s review did not identify any safety concerns, it adds.

GSK describes gepotidacin as a first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication. “This provides activity against most strains of *E. coli* and *S. saprophyticus*, including isolates resistant to current antibiotics.”