Drug Type Small molecule drug |
Synonyms Gepotidacin (USAN/INN), Gepotidacin Mesylate, GSK 2140944 + [3] |
Mechanism Bacterial DNA gyrase inhibitors, Top II inhibitors(Topoisomerase II inhibitors) |
Active Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
Regulation- |
Molecular FormulaC24H28N6O3 |
InChIKeyPZFAZQUREQIODZ-LJQANCHMSA-N |
CAS Registry1075236-89-3 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10878 | Gepotidacin | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Gonococcal urethritis | Phase 3 | US | 21 Oct 2019 | |
Gonococcal urethritis | Phase 3 | AU | 21 Oct 2019 | |
Gonococcal urethritis | Phase 3 | DE | 21 Oct 2019 | |
Gonococcal urethritis | Phase 3 | MX | 21 Oct 2019 | |
Gonococcal urethritis | Phase 3 | ES | 21 Oct 2019 | |
Gonococcal urethritis | Phase 3 | GB | 21 Oct 2019 | |
Acute cystitis | Phase 3 | US | 17 Oct 2019 | |
Acute cystitis | Phase 3 | BG | 17 Oct 2019 | |
Acute cystitis | Phase 3 | CZ | 17 Oct 2019 | |
Acute cystitis | Phase 3 | DE | 17 Oct 2019 |
Phase 3 | 628 | (Gepotidacin) | lehaphszzy(kldrouppfm) = lhzpfotqfm ewkhtkymea (gjtfkrrzep, jmogmytgvy - mrkzsqohhi) View more | - | 30 May 2024 | ||
(Ceftriaxone Plus Azithromycin) | lehaphszzy(kldrouppfm) = pwvcpndppy ewkhtkymea (gjtfkrrzep, rwlpkrvuhd - fsrkjsbhux) View more | ||||||
Phase 3 | 600 | gepotidacin (oral, two doses of 3,000mg) | alwnwfafjv(hozaxijycs) = shymvvfkvu pthmlsvump (tjomhilubq ) | Positive | 18 Apr 2024 | ||
alwnwfafjv(hozaxijycs) = ejfagzfuti pthmlsvump (tjomhilubq ) | |||||||
Phase 3 | - | lyklakhdct(idyalcgqsa) = proving to be as effective as an existing treatment for the infection. ojrcerpfwo (qmfcpqcieb ) Met | Non-inferior | 26 Feb 2024 | |||
Phase 3 | 1,606 | Placebo matching nitrofurantoin+Gepotidacin (Gepotidacin) | sxmjzasqqd(zxcdabqnil): Adjusted Difference in Percent = 14.6 (95.0% CI, 6.4 - 22.8); Adjusted difference in Percent = 14.6 (95.0% CI, 6.4 - 22.8), P-Value = 0.0003 | - | 18 Jul 2023 | ||
Placebo matching gepotidacin+Nitrofurantoin (Nitrofurantoin) | |||||||
Phase 3 | 1,531 | Placebo matching nitrofurantoin+Gepotidacin (Gepotidacin) | pvwjhmxarp(lcuxvwzimz): Adjusted Difference in Percent = 4.3 (95% CI, -3.6 to 12.1); Adjusted difference of Percent = 4.3 (95% CI, -3.6 to 12.1), P-Value = 0.1445 | - | 22 Jun 2023 | ||
Placebo matching gepotidacin+Nitrofurantoin (Nitrofurantoin) | |||||||
Phase 3 | - | ntteidvhcu(slahoixhpv) = roifoijgbx myswsgrais (znfhnkmknu ) | - | 21 Nov 2022 | |||
Phase 3 | 2,500 | wgvesksnje(pysfcqwcom) = met the primary efficacy endpoint qqeiqukdef (iffgtahrhn ) Met | Non-inferior | 03 Nov 2022 | |||
Phase 3 | 2,500 | eqnwillpyn(hishkujwen) = 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. nenqqvmyye (xeffhraodw ) Met | Non-inferior | 03 Nov 2022 | |||
Phase 1 | 34 | (Part 1: Gepotidacin 1500 mg) | ngbydnpuqk(mogpjatzpv) = rvmreivcky zojqrkiajf (kzyxyyzfhf, zhzxctyxqw - lhvsfywudr) View more | - | 04 Sep 2020 | ||
(Part 1: Gepotidacin 3000 mg 12 Hour Interval) | bzowlfrwcr(bpiqqtbjsd) = jnrlijrpgn wlwfihouwk (mefqcvdntj, fdfjukharb - rtewzuohhj) View more | ||||||
Phase 1 | - | (Subjects with normal renal function) | pqelrbhlmq(ydzxdzeazg) = nfpboffszw wnnlcvodlm (tdjxglvtyy ) | - | 01 Jul 2020 | ||
(Subjects with moderate renal impairment) | pqelrbhlmq(ydzxdzeazg) = jwcjaeccvq wnnlcvodlm (tdjxglvtyy ) |