GSK Submits Prospectus for Gepotidacin (Blujepa), a First-in-Class Oral Antibiotic Recently Approved by FDA for Uncomplicated UTIs and Gonorrhea

Drug Name:gepotidacin

CAS：1075236-89-3

R&D Code:GSK2140944

Original Research Company:GSK

On March 25, 2025, the FDA approved gepotidacin (Blujepa) for the treatment of uncomplicated urinary tract infections (UTI) in female adults (40 kg and above) and adolescents (12 years and older; 40 kg and above) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.。

2023Year4Month15Day,GSKPublishedgepotidacinThe KeyEAGLE-2AndEAGLE-3 IIIPositive results from the Phase III clinical trial.

InEAGLE-2 IIIIn the trial period,gepotidacinIn50.6%in patients, showing a treatment success rate, whilenitrofurantoinFor47%. InEAGLE-3 IIIIn the trial period,gepotidacinIn58.5%in patients, showing a treatment success rate, whilenitrofurantoinFor43.6%. In two trials, as of the28Daily follow-up visit,94%AcceptgepotidacinThe patients who were treated did not receive any additional treatments during the trial period.uUTIAntibiotic treatment. InEAGLE-2AndEAGLE-3 IIIIn the trial period,gepotidacinThe safety and tolerability are consistent with previousgepotidacinConsistent trials.

[i]Difference:gepotidacin - nitrofurantoin。Micro-ITT NTF-S (IAGroup), Microbial Intention-to-Treat Nitrofurantoin-Sensitive Population Interim Analysis Group

[ii]Composite Endpoint of Clinical and Microbiological Success

[iii]Clinical Cure Trial Successful(TOC) =Symptom Resolution

[iv]Eligible urinary tract pathogens eradicated to103 CFU/mL

2024Year2Month26Day,GSKAnnouncementgepotidacinCriticalEAGLE-1 IIIPositive Top-Line Results Achieved in the Trial Phase.The trial met its primary efficacy endpoint,gepotidacin(Oral, two doses,3000Milligram)Compared with intramuscular injection(IM)Ceftriaxone(500Milligram)Add oral azithromycin(1000Milligram)In comparison, it demonstrated non-inferiority. The results are based on post-treatment.3-7Day's Treatment Trial(ToC)Access to the primary endpoint of the microbial response.

GepotidacinIt is a novel antibacterial drug that inhibits bacteria through a new mechanism of action and binding site.DNAReplication provides two different types for most pathogens.IIBalanced inhibition of type topoisomerase.

This provides activity against most target urinary tract pathogens and Neisseria gonorrhoeae strains, including isolates resistant to existing antibiotics. Due to the well-balanced inhibition of both enzymes, targeted mutations in both are required to significantly affectgepotidacinSusceptibility.

References:WO2008128942,WO2004058144