21 completed, 1 not yet recruiting, 1 recruiting. 15 Phase 1, 5 Phase 3, 3 Phase 2.
By phase and status
Follow gepotidacin: new trials by email Literature Review of gepotidacin trials Research Report on gepotidacin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics
Gepotidacin, SOC - Urinary Tract Infections | Phase 1 | Not yet recruiting | 25 | 2026-09-18 | 2026-09-28 |
A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women
Gepotidacin - Urinary Tract Infections | Phase 1 | Recruiting | 8 | 2026-07-23 | 2026-09-30 |
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)
Gepotidacin - Urinary Tract Infections | Phase 3 | Completed | 97 | 2024-10-02 | 2026-02-11 |
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
Gepotidacin, Nitrofurantoin, Placebo - Urinary Tract Infections | Phase 3 | Completed | 380 | 2023-01-11 | 2025-03-17 |
A Study to Evaluate Pharmacokinetic, Safety, Tolerability and Relative Bioavailability of Gepotidacin in Healthy Adult Male and Female Participants
Gepotidacin - Healthy Volunteers | Phase 1 | Completed | 24 | 2022-03-01 | 2023-01-30 |
Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue
Gepotidacin - Gonorrhea, Infection, Bacterial | Phase 1 | Completed | 53 | 2021-01-29 | 2025-02-20 |
Drug-drug Interaction Study of Gepotidacin
Gepotidacin, Cimetidine, Rifampicin - Infections, Bacterial | Phase 1 | Completed | 64 | 2020-08-14 | 2022-03-04 |
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
Gepotidacin, Placebo matching nitrofurantoin, Nitrofurantoin - Urinary Tract Infections | Phase 3 | Completed | 1606 | 2020-04-23 | 2023-07-18 |
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
Gepotidacin, Ceftriaxone, Azithromycin - Gonorrhea | Phase 3 | Completed | 628 | 2019-10-21 | 2024-05-30 |
A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)
Gepotidacin, Placebo matching nitrofurantoin, Nitrofurantoin - Urinary Tract Infections | Phase 3 | Completed | 1531 | 2019-10-17 | 2023-06-22 |
Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects
Gepotidacin, Placebo - Infections, Bacterial | Phase 1 | Completed | 34 | 2019-09-04 | 2020-09-04 |
Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)
Gepotidacin - Infections, Bacterial | Phase 2 | Completed | 22 | 2018-07-23 | 2020-06-29 |
Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function
Gepotidacin - Infections, Bacterial | Phase 1 | Completed | 25 | 2018-06-14 | 2021-04-12 |
To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.
Gepotidacin RC Tablet, Gepotidacin HSWG Tablet, Gepotidacin Capsule - Infections, Bacterial | Phase 1 | Completed | 48 | 2016-08-04 | 2020-10-08 |
Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function
Gepotidacin - Infections, Bacterial | Phase 1 | Completed | 32 | 2016-06-29 | 2020-07-21 |
A Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
GSK2140944 - Gonorrhea | Phase 2 | Completed | 106 | 2015-04-15 | 2017-05-23 |
Placebo and Moxifloxacin Controlled Cardiac Conduction Study of GSK2140944 in Healthy Volunteers
GSK2140944, GSK2140944 placebo, Moxifloxacin - Infections, Respiratory Tract | Phase 1 | Completed | 55 | 2014-10-06 | 2017-07-13 |
Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections
GSK2140944 Lyophile, GSK2140944 Capsules - Infections, Bacterial | Phase 2 | Completed | 126 | 2014-03-24 | 2017-11-17 |
Relative Bioavailability, Safety, Tolerability, Pharmacokinetics (PK) and Food Effect Study of GSK2140944 in Healthy Subjects
GSK2140944 capsule, GSK2140944 tablet, Itraconazole capsule - Infections, Bacterial | Phase 1 | Completed | 46 | 2014-01-28 | 2017-07-13 |
A Study to Investigate the Recovery, Excretion and Pharmacokinetics of [14C]-GSK2140944 Administered as a Single Intravenous and Single Oral Dose to Healthy Adult Male Subjects
GSK2140944 for Injection, GSK2140944 Capsule - Infections, Respiratory Tract | Phase 1 | Completed | 6 | 2013-11-08 | 2017-07-13 |
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Conditions studied
Bacterial Infections (11) · Urinary Tract Infections (7) · Respiratory Tract Infections (4) · Gonorrhea (3) · Infections (1) · Kidney Failure, Chronic (1) · Renal Insufficiency (1)
Sponsors
GlaxoSmithKline (22) · Institut National de la Santé Et de la Recherche Médicale, France (1)
Countries
United States (20) · United Kingdom (4) · Australia (2) · Bulgaria (2) · Germany (2) · India (2) · Mexico (2) · Spain (2) · Austria (1) · Czechia (1) · France (1) · Greece (1) · Hungary (1) · Japan (1) · Poland (1)
Results publications
PMID 35769034, PMID 36255258, PMID 34633853, PMID 34978887, PMID 36271314, PMID 38342126, PMID 40372095, PMID 40924001, PMID 40924012, PMID 41399629, PMID 41495938, PMID 42682990, PMID 28223381, PMID 28373199, PMID 29617982, PMID 30249694, PMID 31818823, PMID 34130619, PMID 36411033, PMID 37751016, PMID 40245902, PMID 42809288, PMID 42841733
NIH funding
2018 (2), 2019 (1), 2025 (1)