NDAORALTABLETPriority Review
Approved
Mar 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BLUJEPA (gepotidacin) is a novel oral small-molecule antibiotic approved March 2025 for urinary tract infections, bacterial infections, and gonorrhea. It represents a new mechanistic class addressing multidrug-resistant pathogens in a category with high unmet clinical need. The drug's oral tablet formulation offers convenient dosing for community-acquired infections.
Growth16.6 years to LOE
Early-stage growth product from GSK with minimal competitive pressure (0) indicates opportunity for brand building and market penetration; commercial team will focus on rapid uptake in primary care and urology.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.