NDAORALTABLETPriority Review
Approved
Mar 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
12
Mechanism of Action
[see Microbiology ()] .
Indications (8)
female adultolder weighing at least 40 kilograms (kg) for the treatment of uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escherichia coliKlebsiella pneumoniaeCitrobacter freundii complexStaphylococcus saprophyticusEnterococcus faecalisolder weighing at least 45 kilograms (kg)no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae
Clinical Trials (5)
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)
Started Oct 2024
97 enrolled
Urinary Tract Infections
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
Started Jan 2023
380 enrolled
Urinary Tract Infections
A Study to Evaluate Pharmacokinetic, Safety, Tolerability and Relative Bioavailability of Gepotidacin in Healthy Adult Male and Female Participants
Started Mar 2022
24 enrolled
Healthy Volunteers
Drug-drug Interaction Study of Gepotidacin
Started Aug 2020
64 enrolled
Infections, Bacterial
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
Started Apr 2020
1,606 enrolled
Urinary Tract Infections
Loss of Exclusivity
LOE Date
Dec 13, 2042
204 months away
Patent Expiry
Dec 13, 2042
Exclusivity Expiry
Mar 25, 2035