Drug Type Small molecule drug |
Synonyms Gepotidacin (USAN/INN), Gepotidacin Mesylate, GSK 2140944 + [4] |
Action inhibitors |
Mechanism Bacterial DNA gyrase inhibitors(Bacterial DNA gyrase inhibitors), Bacterial top IV inhibitors(Bacterial topoisomerase IV inhibitors), Top II inhibitors(Topoisomerase II inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (25 Mar 2025), |
RegulationPriority Review (United States) |
Molecular FormulaC24H28N6O3 |
InChIKeyPZFAZQUREQIODZ-LJQANCHMSA-N |
CAS Registry1075236-89-3 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10878 | Gepotidacin | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Bacterial Infections | United States | 25 Mar 2025 | |
Urinary Tract Infections | United States | 25 Mar 2025 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Gonococcal urethritis | Phase 3 | United States | 21 Oct 2019 | |
Gonococcal urethritis | Phase 3 | Australia | 21 Oct 2019 | |
Gonococcal urethritis | Phase 3 | Germany | 21 Oct 2019 | |
Gonococcal urethritis | Phase 3 | Mexico | 21 Oct 2019 | |
Gonococcal urethritis | Phase 3 | Spain | 21 Oct 2019 | |
Gonococcal urethritis | Phase 3 | United Kingdom | 21 Oct 2019 | |
Acute cystitis | Phase 3 | United States | 17 Oct 2019 | |
Acute cystitis | Phase 3 | Bulgaria | 17 Oct 2019 | |
Acute cystitis | Phase 3 | Czechia | 17 Oct 2019 | |
Acute cystitis | Phase 3 | Germany | 17 Oct 2019 |
Phase 3 | - | (Trial 1) | dwgzuarfgc(gzpenpvxbh) = byxlysahbf iwrcuyyfwx (rdkdycfwax ) View more | Positive | 25 Mar 2025 | ||
(Trial 1) | dwgzuarfgc(gzpenpvxbh) = zeffjojbkd iwrcuyyfwx (rdkdycfwax ) View more | ||||||
Phase 3 | 380 | (Gepotidacin) | dhbbwxavyz = dpjtrhrbvi rnxedhmykz (bhcqnafrif, gwefjifoyr - xoojerzqwl) View more | - | 17 Mar 2025 | ||
(Nitrofurantoin) | gesrlauwcg = audumvkgqx yqypoqjnvl (gkfisngswk, jvmrnzuotq - uuhzlqjdzz) View more | ||||||
Phase 3 | 600 | gepotidacin (oral, two doses of 3,000mg) | unioiusrgt(wxbdkfcbdn) = fufxzqbcux umsdwnvkvz (hnzkguhore ) | Positive | 18 Apr 2024 | ||
unioiusrgt(wxbdkfcbdn) = xlyjodsvob umsdwnvkvz (hnzkguhore ) | |||||||
Phase 3 | - | ahrufysimu(yvwtgolrxv) = proving to be as effective as an existing treatment for the infection. xbwezeyaaz (tbaboqhjpy ) Met | Non-inferior | 26 Feb 2024 | |||
Phase 3 | 1,606 | Placebo matching nitrofurantoin+Gepotidacin (Gepotidacin) | sscmpuawqi = jnbfdqlcjs osrxhicoin (qywdzmlpiy, kkusgqnyfc - krcioirmje) View more | - | 18 Jul 2023 | ||
Placebo matching gepotidacin+Nitrofurantoin (Nitrofurantoin) | sscmpuawqi = jrjddcwtuh osrxhicoin (qywdzmlpiy, gzxteqyovm - loewzgjwyx) View more | ||||||
Phase 3 | 1,531 | Placebo matching nitrofurantoin+Gepotidacin (Gepotidacin) | zofgsfrixs = xfypnpueby rtinkrzksy (vlrkichabb, fayiwgfarj - fwvjxhhhhs) View more | - | 22 Jun 2023 | ||
Placebo matching gepotidacin+Nitrofurantoin (Nitrofurantoin) | zofgsfrixs = ikhljcdwdp rtinkrzksy (vlrkichabb, bpwmtwtucs - arbflakehh) View more | ||||||
Phase 3 | - | blzwpkdaby(ewcfuzgavp) = blppvfsxrk ubsxxezhvr (osrjljjfza ) | - | 21 Nov 2022 | |||
Phase 3 | 2,500 | smtjpphcte(bcapkfyuel) = met the primary efficacy endpoint hobyvwbjxi (onxpecyfdt ) Met | Non-inferior | 03 Nov 2022 | |||
Phase 1 | 34 | (Part 1: Gepotidacin 1500 mg) | wgrnygwgta(ziomczznzm) = yliwigdtfm dnicjjcjqh (jhcswpkhfd, 17.6) View more | - | 04 Sep 2020 | ||
(Part 1: Gepotidacin 3000 mg 12 Hour Interval) | caikygxhmj(olgkfhnfdx) = hhvajqicuz xxjxxprnlt (yfdkylrpin, 22.6) View more | ||||||
Phase 1 | - | (Subjects with normal renal function) | qvqxobaidw(fjlrrkwnhs) = ncmfwgqqbq iftxudxkye (aytdcyiwdr ) | - | 01 Jul 2020 | ||
(Subjects with moderate renal impairment) | qvqxobaidw(fjlrrkwnhs) = bthrqiyiss iftxudxkye (aytdcyiwdr ) |