Blujepa (Gepotidacin)
Blujepa is an FDA-approved oral antibiotic containing gepotidacin, a novel bacterial type II topoisomerase inhibitor, indicated specifically for uncomplicated urinary tract infections (uUTIs) in female patients aged ≥12 years and weighing ≥40 kg. 1
Drug Classification and Mechanism
- Gepotidacin represents a first-in-class triazaacenaphthylene bacterial type II topoisomerase inhibitor (BTI) with a novel mechanism of action distinct from fluoroquinolones and other existing antibiotics 1
- The drug was developed by GSK and received FDA approval in March 2025 for bacterial uUTIs 1
FDA-Approved Indications
Blujepa is approved for treating uncomplicated urinary tract infections caused by susceptible isolates of the following organisms: 1
- Escherichia coli
- Klebsiella pneumoniae
- Citrobacter freundii complex
- Staphylococcus saprophyticus
- Enterococcus faecalis
Patient Population
- Female adult and pediatric patients aged ≥12 years 1
- Minimum weight requirement: ≥40 kg 1
- The approval is specifically limited to uncomplicated urinary tract infections, not complicated UTIs or other infection types 1
Clinical Context
- Gepotidacin was also developed for uncomplicated urogenital gonorrhea (uUGC), though the current FDA approval is limited to uUTIs 1
- This represents an important addition to the antibiotic armamentarium, particularly given rising resistance patterns to traditional UTI antibiotics 1
Important Caveat
Do not confuse Blujepa (gepotidacin antibiotic) with other products containing "blujepa" in the name that may be antiseptic cleansers for perineal use 2 - these are entirely different products with different indications and should not be substituted for one another.