GSK's First-in-Class Antibiotic Gepotidacin Receives IND Acceptance in China for Uncomplicated Urinary Tract Infections

Source: PharmaCube Info

Author: Shi Bei

On November 11, the CDE website showed that the clinical application of Gepotidacin Tablets, a new antibiotic from GlaxoSmithKline (GSK), was accepted by the National Medical Products Administration.

Gepotidacin is a first-in-class triazaacenaphthylene class type II topoisomerase inhibitor. Unlike all currently approved antibiotics, Gepotidacin is an oral formulation with a novel "dual-targeting" mechanism of action (MOA). It exerts its therapeutic effects by selectively interacting with two key bacterial enzymes—DNA gyrase and topoisomerase IV (type II topoisomerases)—which are responsible for bacterial replication. This new antibiotic is active against most pathogens that are resistant to existing antibiotics, including fluoroquinolones.

Gepotidacin Structure

Outside of China, GSK launched a Phase III clinical program in October 2019 to evaluate gepotidacin for the treatment of uncomplicated urinary tract infections (uUTI). The program includes two studies, with the first study (EAGLE-1) enrolling approximately 600 patients with urogenital gonorrhea (GC), one of the most common sexually transmitted infections. The aim is to assess the efficacy of gepotidacin compared to the guideline-recommended dual therapy regimen of ceftriaxone and azithromycin.

The second study (EGEL-2) was conducted in approximately 1200 patients with uUTI, a common infectious disease in women, aiming to evaluate the efficacy of gepotidacin versus the first-line antibiotic nitrofurantoin.