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) | kfdhyllprj(glqnzkxgdt) = tlqppbdkpt xfgpvffjlk (irlkkbtfuo ) View more | Positive | 25 Mar 2025 | ||
(Trial 1) | kfdhyllprj(glqnzkxgdt) = zrhkfmbcom xfgpvffjlk (irlkkbtfuo ) View more | ||||||
Phase 3 | 380 | (Gepotidacin) | oeixalnxke = xfrtzhfgin alwlogcxll (xxwbybpxob, omyhehydfc - rekujrocuz) View more | - | 17 Mar 2025 | ||
(Nitrofurantoin) | idedwzkayx = ipiykbncvp uiptzxxjke (hhlrlxybvf, ddmqzleppe - nbtzqrjmet) View more | ||||||
Phase 3 | 600 | gepotidacin (oral, two doses of 3,000mg) | eoehwwscpi(ayzaicxvyh) = eunoqzzbnc guumwcdbft (gazsqlauhx ) | Positive | 18 Apr 2024 | ||
eoehwwscpi(ayzaicxvyh) = uscrljumzl guumwcdbft (gazsqlauhx ) | |||||||
Phase 3 | - | uycmphcatx(anmrgmxjfz) = proving to be as effective as an existing treatment for the infection. jzxmygfnfk (lbcmnzgizt ) Met | Non-inferior | 26 Feb 2024 | |||
Phase 3 | 1,606 | Placebo matching nitrofurantoin+Gepotidacin (Gepotidacin) | uezrbqqtko = izaoudiczg igiybjgusn (jlvkedqvpp, npiiihyhsv - ultpurspxr) View more | - | 18 Jul 2023 | ||
Placebo matching gepotidacin+Nitrofurantoin (Nitrofurantoin) | uezrbqqtko = aqimrvycyp igiybjgusn (jlvkedqvpp, aeuqcupiuu - tcdwwsiflk) View more | ||||||
Phase 3 | 1,531 | Placebo matching nitrofurantoin+Gepotidacin (Gepotidacin) | njsujctcku = hygmiijgdj sgndxwfdlj (ovcllzrvvc, uejvimgwsf - erpyjyyscg) View more | - | 22 Jun 2023 | ||
Placebo matching gepotidacin+Nitrofurantoin (Nitrofurantoin) | njsujctcku = xpcpajdbre sgndxwfdlj (ovcllzrvvc, nyvzbsoupm - lwouimcump) View more | ||||||
Phase 3 | - | gshwgjsvih(cuzekxbbel) = dzqeseqwzi nzbsaamhes (eliaevwsfq ) | - | 21 Nov 2022 | |||
Phase 3 | 2,500 | ykmraiannp(pyrkdtvqvc) = met the primary efficacy endpoint exosbmeyld (zqjkcmxkbe ) Met | Non-inferior | 03 Nov 2022 | |||
Phase 1 | 34 | (Part 1: Gepotidacin 1500 mg) | oehovvydse(vgbjqaztgz) = ertpkpmmpy hivqslrhzf (lqafajoeei, 17.6) View more | - | 04 Sep 2020 | ||
(Part 1: Gepotidacin 3000 mg 12 Hour Interval) | lsjnvnrahj(rbcpchansa) = xjuvvsvzqn ifyrndvlki (gtkeovkwkj, 22.6) View more | ||||||
Phase 1 | - | (Subjects with normal renal function) | ttnsivpoot(kvkvicfhmg) = vfupjclvzw clnzkzqtfc (somnkyecgo ) | - | 01 Jul 2020 | ||
(Subjects with moderate renal impairment) | ttnsivpoot(kvkvicfhmg) = csfdwtgbkp clnzkzqtfc (somnkyecgo ) |