Drugs / Gepotidacin
Gepotidacin
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed gonococcal epididymo-orchitis 1 milestone | |||||
| Filed | US (FDA) | — | gonococcal epididymo-orchitis | 2025-08-11 | “the US Food and Drug Administration (FDA) has accepted for priority review a supplemental New Drug Application for gepotidacin” gsk.com ↗ |
| Filed urinary tract infection 1 milestone | |||||
| Filed | US (FDA) | — | urinary tract infection | 2024-10-16 | “the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for gepotidacin” gsk.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | BLUJEPA | — | 2025-12-11 | fda.gov ↗ |
| Approved | US (FDA) | BLUJEPA | — | 2025-03-25 | fda.gov ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 116 trials | ||||||
| Phase 1 | NCT07371429 | Sep 2026 → Aug 2027 expected | urinary tract infection | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07645235 | Jul 2026 → May 2027 expected | urinary tract infection | GlaxoSmithKline | 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 | Mixed |
| 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 | Mixed |
| Phase 35 trials · 3 met primary | ||||||
| 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 | Met primary |
| Phase 3 | NCT04010539 | Oct 2019 → Oct 2023 | gonorrhea | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT04020341 | Oct 2019 → Nov 2022 | urinary tract infection | GlaxoSmithKline | Completed | Met primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-12-11 | GlaxoSmithKline | Regulatory Blujepa (gepotidacin) approved by US FDA as oral option for treatment of uncomplicated urogenital gonorrhoea (uGC) gsk.com ↗
With this approval, gepotidacin is now available to US patients for the treatment of uncomplicated urogenital gonorrhoea when appropriate. |
| 2025-08-11 | GlaxoSmithKline | Regulatory Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea gsk.com ↗ |
| 2025-03-25 | GlaxoSmithKline | Regulatory Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older gsk.com ↗ |
| 2024-10-16 | GlaxoSmithKline | Regulatory Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents gsk.com ↗
The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of 26 March 2025. |
| 2024-10-10 | GlaxoSmithKline | Results GSK and ViiV Healthcare to showcase advances across industry-leading infectious disease portfolio at IDWeek 2024 gsk.com ↗
Discordant Clinical and Microbiological Responses are Associated with Late Clinical Relapse in Uncomplicated Urinary Tract Infections: Pooled Analysis of EAGLE-2/EAGLE-3 Trial Data |
| 2024-04-17 | GlaxoSmithKline | Results EAGLE-1 phase III data show potential for gepotidacin as a new oral treatment option for uncomplicated urogenital gonorrhoea (GC) amid growing resistance to existing treatments gsk.com ↗
Gepotidacin achieved a 92.6% microbiological success rate and was non-inferior to the leading combination treatment |
| 2024-02-26 | GlaxoSmithKline | Results GSK announces positive headline results from EAGLE-1 phase III trial for gepotidacin in uncomplicated urogenital gonorrhoea (GC) gsk.com ↗
The trial met its primary efficacy endpoint, with gepotidacin (oral, two doses of 3,000mg) demonstrating non-inferiority to intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg), a leading combination treatment regimen for gonorrhoea. |
| 2023-04-15 | GlaxoSmithKline | Results Gepotidacin’s positive phase III data shows potential to be the first in a new class of oral antibiotics for uncomplicated urinary tract infections in over 20 years gsk.com ↗
GSK plc (LSE/NYSE: GSK) presented positive results from the pivotal EAGLE-2 and EAGLE-3 phase III trials for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urinary tract infections (uUTI) in female adults and adolescents. |
| 2022-11-03 | GlaxoSmithKline | Results EAGLE-2 and EAGLE-3 phase III trials for gepotidacin stopped early for efficacy following pre-planned interim analysis by Independent Data Monitoring Committee gsk.com ↗
The EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint of combined clinical and microbiological resolution following treatment at the Test-Of-Cure (TOC) visit for gepotidacin versus nitrofurantoin in patients with a confirmed uUTI and a uropathogen sensitive to nitrofurantoin. |
| 2016-09-19 | GlaxoSmithKline | Regulatory GSK sets out further steps to address emerging global health security challenges gsk.com ↗
This week, GSK announces that the most advanced asset in its antibiotic pipeline – gepotidacin (GSK2140944) – which has a novel mechanism of action, has been granted Qualified Infectious Disease Product status by the Food and Drug Administration |
All press releases naming this drug 11 releases
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 ↗ |