Trial Profile
A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
Status:
Discontinued
Phase of Trial:
Phase III
Latest Information Update: 27 Mar 2025
Price :
$35
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At a glance
- Drugs Gepotidacin (Primary) ; Nitrofurantoin
- Indications Bacterial cystitis; Urinary tract infections
- Focus Registrational; Therapeutic Use
- Acronyms EAGLE-2
- Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK
- 25 Mar 2025 According to a GlaxoSmithKline media release, company announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults and paediatric patients with uncomplicated urinary tract infections based on on data from the pivotal phase III EAGLE-2 and EAGLE-3 trials
- 16 Nov 2024 According to a GlaxoSmithKline media release, company announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for the treatment of female adults (40 kg) and adolescents (12 years, 40 kg) with uncomplicated urinary tract infections (uUTIs).
- 16 Oct 2024 According to a GlaxoSmithKline media release, The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of 26 March 2025.