Blujepa (gepotidacin) / GSK - LARVOL DELTA

Gepotidacin shows promise for the treatment of uncomplicated gonorrhoea. (PubMed, Lancet) - No abstract available

Journal • Infectious Disease

Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. (PubMed, Lancet) - P3 | "Gepotidacin demonstrated non-inferiority to ceftriaxone plus azithromycin for urogenital N gonorrhoeae, with no new safety concerns, offering a novel oral treatment option for uncomplicated urogenital gonorrhoea."

Head-to-Head • Journal • P3 data • Gastrointestinal Disorder • Infectious Disease • Nephrology

Gepotidacin: The first-in-class triazaacenaphthylene antibiotic approved for the treatment of uncomplicated urinary tract infections. (PubMed, Drug Discov Ther) - "Results of clinical trials indicated the non-inferiority of gepotidacin compared to the current standard therapy, nitrofurantoin. The most frequently reported adverse reaction to gepotidacin was mild to moderate diarrhea. The approval of gepotidacin represents a progress in antibiotic innovation, offering novel perspectives on drug development while spurring global efforts to tackle the escalating challenge of antimicrobial resistance."

Journal • Infectious Disease • Nephrology • Pediatrics

Phase 3 randomised trial of oral gepotidacin for the treatment of uncomplicated gonorrhoea (EAGLE-1) (ESCMID Global 2025) - "Organised by The Lancet group"

Clinical • Late-breaking abstract • P3 data • Infectious Disease

Design of a Phase 3b, open-label, single-arm study evaluating clinical symptom improvement with gepotidacin in participants with uncomplicated urinary tract infection (uUTI) (ESCMID Global 2025) - No abstract available

Clinical • P3 data • Infectious Disease • Nephrology

Gepotidacin and nitrofurantoin efficacy by baseline uropathogen drug-resistant phenotypes recovered from EAGLE-2/EAGLE-3 clinical trials for uncomplicated urinary tract infections (ESCMID Global 2025) - No abstract available

Clinical • Infectious Disease • Nephrology

In vitro activity of gepotidacin against baseline uropathogens including drug-resistant phenotypes recovered from EAGLE-2/EAGLE-3 clinical trials for uncomplicated urinary tract infections (ESCMID Global 2025) - No abstract available

Preclinical • Infectious Disease • Nephrology

Gepotidacin MIC determination: comparative evaluation of a new gradient strip to the CLSI 2024 reference method on 290 clinical isolates (ESCMID Global 2025) - No abstract available

Clinical

Gepotidacin activity against and analysis of susceptibility to oral standard-of-care antibiotics for urinary tract infections caused by Escherichia coli and Klebsiella pneumoniae collected in Europe in 2023 (ESCMID Global 2025) - No abstract available

Infectious Disease • Nephrology • Pneumonia

Activity of gepotidacin against molecularly characterised beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae isolates from patients with urinary tract infections in Europe and adjacent regions (2023) (ESCMID Global 2025) - No abstract available

Clinical • Infectious Disease • Nephrology • Pneumonia

Gepotidacin activity against Escherichia coli and Klebsiella pneumoniae, including molecularly characterised fluoroquinolone not susceptible subsets causing urinary tract infections in Europe and adjacent regions (2023) (ESCMID Global 2025) - No abstract available

Infectious Disease • Nephrology • Pneumonia

Phase 3 study of oral gepotidacin for the treatment of uncomplicated urinary tract infection in Japanese female participants (EAGLE-J) (ESCMID Global 2025) - No abstract available

P3 data • Infectious Disease • Nephrology

Blujepa (gepotidacin) Approved by US FDA for Treatment of Uncomplicated Urinary Tract Infections (uUTIs) in Female Adults and Pediatric Patients 12 Years of Age and Older (Businesswire) - "GSK plc...announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis....The approval is based on positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with a confirmed uUTI....US commercial launch is planned in 2H 2025."

FDA approval • Launch US • Infectious Disease

SIS: A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis) (clinicaltrials.gov) - P3 | N=97 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Infectious Disease • Nephrology

Plain language summary: efficacy and safety of gepotidacin, a new oral antibiotic, compared with nitrofurantoin, a commonly used oral antibiotic, for treating uncomplicated urinary tract infection. (PubMed, Future Microbiol) - No abstract available

Journal • Infectious Disease • Nephrology

How Do Gepotidacin and Zoliflodacin Stabilize DNA-Cleavage Complexes with Bacterial Type IIA Topoisomerases? 2. A Single Moving Metal Mechanism. (PubMed, Int J Mol Sci) - "Although the proposed mechanism is consistent with published data, it is not proven and other mechanisms have been proposed. Finally, how such mechanisms can be experimentally distinguished is considered."

Journal • Psychiatry

Screening of the Pandemic Response Box library identified promising compound candidates against extensively drug-resistant Acinetobacter baumannii (ASTMH 2024) - "In this study, we assessed 400 structurally diverse compounds from the Medicines for Malaria Pandemic Response Box for their activity against two clinical isolates of A. baumannii: A. baumannii 5075, known for its extensive drug resistance, and A. baumannii QS17-1084, obtained from an infected wound in a Thai patient and displaying resistance to nearly all antimicrobial classes, including tetracycline. Our findings highlight gepotidacin, epetraborole, and eravacycline as promising candidates for further evaluation in murine wound infection models against multidrug-resistant A. baumannii. These compounds hold potential for addressing the critical need for effective antibiotics in the face of rising antimicrobial resistance."

Infectious Disease • Malaria

SIS: A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis) (clinicaltrials.gov) - P3 | N=90 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Nephrology

Molecular mechanism of a triazole-containing inhibitor of Mycobacterium tuberculosis DNA gyrase. (PubMed, iScience) - "High-resolution cryo-electron microscopy structural analysis provides detailed insights into the ternary complex formed by the Mtb gyrase, double-stranded DNA, and either BDM71403 or gepotidacin, providing a rational framework to understand the superior in vitro efficacy on Mtb. This study highlights the potential of triazole-based scaffolds as promising gyrase inhibitors, offering new avenues for drug development in the fight against antimicrobial resistance."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Efficacy and Safety of Gepotidacin for Uncomplicated Urinary Tract Infection: Pooled Subgroup Analyses of the EAGLE-2 and EAGLE-3 Randomised Phase 3 Trials (DGU 2024) - P3 | "GSK-sponsored studies (EAGLE-2 [204989]/EAGLE-3 [212390]); EAGLE-2 was also supported in whole or part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (HHSO100201300011C).BID, twice daily; CFU, colony-forming units; CI, confidence interval; CrCL, creatinine clearance; GEP, gepotidacin; micro-ITT NTF-S, microbiological intent-to-treat nitrofurantoin-susceptible; NC, not calculable; NTF, nitrofurantoin; uUTI; uncomplicated urinary tract infection.Declaration. This abstract is an encore of Hooton et al., titled: ''Efficacy and Safety of Gepotidacin for Uncomplicated Urinary Tract Infection: Pooled Subgroup Analyses of the EAGLE-2 and EAGLE-3 Randomised Phase 3 Trials'' [2831]."

Clinical • P3 data • Infectious Disease • Nephrology

Impact of Regulatory Guidelines on Therapeutic, Clinical, and Microbiological Success Rates in Uncomplicated Urinary Tract Infection: Results from Two Phase 3 Randomized Controlled Trials of Oral Gepotidacin (EAGLE-2 and EAGLE-3) (DGU 2024) - P3 | "We show the impact of new endpoint guidance on results.EAGLE-2/3 (NCT04020341/NCT04187144; Phase 3 noninferiority RCTs) compared efficacy and safety of GEP 1500mg vs nitrofurantoin (NTF) 100mg BID for 5 days in female patients (≥12yrs) with uUTI. †Difference: GEP–NTF, calculated using Miettinen-Nurminen summary score method adjusting for age and recurrence history. ‡Near clinical success was defined as reduction of symptom score to ≤1, where 0 is complete resolution of symptoms and 1 signifies a single, mild symptom remaining."

Clinical • P3 data • Infectious Disease • Nephrology

SIS: A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis) (clinicaltrials.gov) - P3 | N=90 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Infectious Disease • Nephrology

In vitro Activity of Gepotidacin against Klebsiella pneumoniae, Including Molecularly Characterized ESBL and Carbapenemase positive Subsets Causing Urinary Tract Infections in the United States (2019-2022) (IDWeek 2024) - No abstract available

Preclinical • Infectious Disease

In vitro Activity of Gepotidacin against Klebsiella pneumoniae, Including Molecularly Characterized Fluoroquinolone not Susceptible Subsets Causing Urinary Tract Infections in the United States (2019-2022) (IDWeek 2024) - No abstract available

Preclinical • Infectious Disease

In vitro Activity of Gepotidacin and Comparator Agents against a Collection of K. pneumoniae Urine Isolates from the United States During 2019-2022 (IDWeek 2024) - No abstract available

Preclinical • Infectious Disease