Gepotidacin, the result of a 2013 public-private partnership between GSK and BARDA, is an investigational bactericidal, 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.
presented positive results from two pivotal phase 3 trials. In the EAGLE-2 trial, gepotidacin demonstrated therapeutic success in 50.6% of patients compared to 47% for nitrofurantoin. In the EAGLE-3 trial, gepotidacin demonstrated therapeutic success in 58.5% of patients compared to 43.6% for nitrofurantoin.
If approved, gepotidacin would be the first in a new class of oral antibiotics for UTIs in over 20 years. When sharing the trial results, GSK had targeted a June 2023 regulatory filing, but has seemingly delayed the submission, later sharing an expected regulatory decision by 2025.
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