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Blujepa (GEPOTIDACIN)
Blujepa works by inhibiting bacterial DNA polymerase, preventing the replication of bacterial DNA and ultimately leading to bacterial cell death.
At a glance
| Generic name | GEPOTIDACIN |
|---|---|
| Sponsor | Glaxosmithkline |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
BLUJEPA is an antibacterial drug [see Microbiology ( 12.4 )] .
Approved indications
- Uncomplicated urinary tract infections
- Uncomplicated urogenital gonorrhea
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
- Flatulence
- Dizziness
- Soft feces
- Headache
- Fatigue
- Hyperhidrosis
- Rash
- Tachycardia
Drug interactions
- CYP3A4 Inhibitors
- Strong CYP3A4 inhibitors
- Moderate CYP3A4 inhibitors
- CYP3A4 Inducers
- Strong CYP3A4 inducers
- Moderate CYP3A4 inducers
- CYP3A4 Substrates
- Digoxin
- Succinylcholine-type neuromuscular blocking agents
- Acetylcholinesterase inhibitors
- Systemic anticholinergic medications
- Non-depolarizing neuromuscular blocking agents
Key clinical trials
- A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics (PHASE1)
- 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) (PHASE3)
- A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis) (PHASE3)
- Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue (PHASE1)
- A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea (PHASE3)
- Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI) (PHASE3)
- A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI) (PHASE3)
- A Study to Evaluate Pharmacokinetic, Safety, Tolerability and Relative Bioavailability of Gepotidacin in Healthy Adult Male and Female Participants (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Blujepa CI brief — competitive landscape report
- Blujepa updates RSS · CI watch RSS
- Glaxosmithkline portfolio CI