Drugs / Gepotidacin
Gepotidacin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | BLUJEPA | — | 2025-12-11 | fda.gov ↗ |
| Approved | US (FDA) | BLUJEPA | — | 2025-03-25 | fda.gov ↗ |
Trials 24 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 116 trials | ||||||
| Phase 1 | NCT07645235 | Jul 2026 → May 2027 expected | urinary tract infection | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07371429 | Apr 2026 → Aug 2027 expected | urinary tract infection | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05271799 | Mar → Apr 2022 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT04484740 | Jan 2021 → May 2023 | gonorrhea | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 1 | NCT04493931 | Aug → Dec 2020 | bacterial infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT04079790 | Sep → Nov 2019 | bacterial infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT03562117 | Jun → Dec 2018 | bacterial infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02853435 | Aug 2016 → Oct 2017 | bacterial infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02729038 | Jun 2016 → Jun 2017 | bacterial infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02257398 | Oct 2014 → Mar 2015 | respiratory tract infectious disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02045849 | Jan → Aug 2014 | bacterial infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02000765 | Nov 2013 | respiratory tract infectious disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01934205 | Sep → Dec 2013 | bacterial infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01706315 | Oct 2012 → Dec 2013 | respiratory tract infectious disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01615796 | Jun 2012 → Feb 2014 | respiratory tract infectious disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02202187 | Sep 2011 → Feb 2012 | respiratory tract infectious disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03568942 | Jul 2018 → Jan 2019 | bacterial infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02294682 | Apr 2015 → Jul 2016 | gonorrhea | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02045797 | Mar 2014 → Jun 2015 | gram-positive bacterial infections | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06597344 | Oct 2024 → Mar 2025 | urinary tract infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT05630833 | Jan 2023 → Feb 2024 | urinary tract infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04187144 | Apr 2020 → Dec 2022 | urinary tract infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04010539 | Oct 2019 → Oct 2023 | gonorrhea | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04020341 | Oct 2019 → Nov 2022 | urinary tract infection | GlaxoSmithKline | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gepotidacin | “Efficacy, Safety, and Tolerability of Gepotidacin (GSK2140944) in the Treatment of Patients with Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections.” PMID 28373199 ↗ May 201716“Gepotidacin is a novel, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct mechanism of action” PMID 36411033 ↗ Nov 2022 |
| Known as | Gepotidacin mesilate dihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3317856 ↗ |
| Known as | GEPOTIDACIN MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3317856 ↗ |
| Known as | Gepotidacin mesylate dihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3317856 ↗ |
| Known as | Gepotidacina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3317856 ↗ |
| Known as | Gepotidacine | ChEMBL registry synonym — accepted as the source's own label CHEMBL3317856 ↗ |
| Known as | GSK-2140944 MESYLATE DIHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3317856 ↗ |
| Known as | GSK-2140944E | ChEMBL registry synonym — accepted as the source's own label CHEMBL3317856 ↗ |
| Known as | GSK140944 | “Microbiome recovery in adult females with uncomplicated urinary tract infections in a randomised phase 2A trial of the novel antibiotic gepotidacin (GSK140944).” PMID 34130619 ↗ Jun 2021 |
| Known as | GSK2140944 | “Efficacy, Safety, and Tolerability of Gepotidacin (GSK2140944) in the Treatment of Patients with Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections.” PMID 28373199 ↗ May 201713“Pharmacokinetics of Gepotidacin (GSK2140944) in Male and Female Adult Subjects With Varying Degrees of Renal Impairment and in Matched Control Subjects With Normal Renal Function” NCT02729038 ↗ “Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function” NCT03562117 ↗ “Dose Selection for Phase III Clinical Evaluation of Gepotidacin (GSK2140944) in the Treatment of Uncomplicated Urinary Tract Infections.” PMID 34978887 ↗ Jan 2022 “Dose selection for a phase III study evaluating gepotidacin (GSK2140944) in the treatment of uncomplicated urogenital gonorrhoea.” PMID 36411033 ↗ Nov 2022 “Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)” NCT03568942 ↗ “Pharmacokinetics of Oral Formulations of Gepotidacin (GSK2140944), a” PMID 34633853 ↗ Oct 2021 |
| Action | Inhibit | “Bacterial Type II Topoisomerase Inhibitor (BTI) class” NCT01615796 ↗ |
| Modality | Small molecule | “Gepotidacin is a novel, first-in-class, triazaacenaphthylene antibacterial agent” PMID 28373199 ↗ May 2017 |
| Route | Intravenous | “intravenous (IV) formulation” NCT01615796 ↗ |