Blujepa

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Urinary Tract Infection5 trials

A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)

Completed·GSK·Phase 3·NCT05630833·380 enrolled

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)

Completed·GSK·Phase 3·NCT06597344·97 enrolled

A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)

Completed·GSK·Phase 3·NCT04020341·1,531 enrolled

Show 2 more trials

Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)

Completed·GSK·Phase 2·NCT03568942·22 enrolled

Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)

Completed·GSK·Phase 3·NCT04187144·1,606 enrolled

Urinary Tract Infections2 trials

A Phase 1 Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Gepotidacin in Healthy Lactating Women

Recruiting·GSK·Phase 1·NCT07645235·8 enrolled

Phase 1, Open-Label, Single Arm (Non-comparator) Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Oral Gepotidacin in Addition to Antibacterial Standard of Care in Pediatric Participants From 2 to Less Than 12 Years of Age With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis With Antibiotics

Not yet recruiting·GSK·Phase 1·NCT07371429·25 enrolled

Interaction1 trial

Drug-drug Interaction Study of Gepotidacin

Completed·GSK·Phase 1·NCT04493931·64 enrolled

Renal Impairment1 trial

Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function

Completed·GSK·Phase 1·NCT02729038·32 enrolled

Female1 trial

A Study to Evaluate Pharmacokinetic, Safety, Tolerability and Relative Bioavailability of Gepotidacin in Healthy Adult Male and Female Participants

Completed·GSK·Phase 1·NCT05271799·24 enrolled

5 more indications

Tics1 trial

To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.

Completed·GSK·Phase 1·NCT02853435·48 enrolled

Hepatic Impairment1 trial

Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function

Completed·GSK·Phase 1·NCT03562117·25 enrolled

Antibiotic1 trial

Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue

Completed·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 1·NCT04484740·53 enrolled

Adolescent1 trial

Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects

Completed·GSK·Phase 1·NCT04079790·34 enrolled

Gonorrhea1 trial

A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

Completed·GSK·Phase 3·NCT04010539·628 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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