Last update 08 May 2025

Gepotidacin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Gepotidacin (USAN/INN), Gepotidacin Mesylate
+ [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)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States)
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Structure/Sequence

Molecular FormulaC24H28N6O3
InChIKeyPZFAZQUREQIODZ-LJQANCHMSA-N
CAS Registry1075236-89-3

External Link

KEGGWikiATCDrug Bank
D10878Gepotidacin-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Bacterial Infections
United States
25 Mar 2025
Bacterial Infections
United States
25 Mar 2025
Urinary Tract Infections
United States
25 Mar 2025
Urinary Tract Infections
United States
25 Mar 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute cystitisPreclinical
Germany
17 Oct 2019
Acute cystitisPreclinical
Spain
17 Oct 2019
Acute cystitisPreclinical
Mexico
17 Oct 2019
Acute cystitisPreclinical
Hungary
17 Oct 2019
Acute cystitisPreclinical
Greece
17 Oct 2019
Acute cystitisPreclinical
Romania
17 Oct 2019
Acute cystitisPreclinical
Czechia
17 Oct 2019
Acute cystitisPreclinical
United States
17 Oct 2019
Acute cystitisPreclinical
India
17 Oct 2019
Acute cystitisPreclinical
Bulgaria
17 Oct 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
(Trial 1)
(pxeganejuw) = ablcghwrkj vhqxodntox (vylidncfqk )
Positive
25 Mar 2025
(pxeganejuw) = kwjbrmclwx vhqxodntox (vylidncfqk )
Phase 3
380
(Gepotidacin)
kozxwmxqcl(qtwchnijws) = ovpluztfkc vbfiijpikc (yxlgvaompz, wcqzbsboze - mwdhqnvcgi)
-
17 Mar 2025
(Nitrofurantoin)
dggwmvyghw(aedvdghzxd) = rbbqfithpm wmbyxufeme (ywrnzmasoy, rktsvgafat - degtjfxwwz)
Phase 3
628
(Gepotidacin)
wszxokyfzs(rmyxryespn) = gbeeprbarz jdvhhrhqcy (afecquvgxh, iejyswejxx - ndqersgfnx)
-
30 May 2024
(Ceftriaxone Plus Azithromycin)
wszxokyfzs(rmyxryespn) = xpyobjyorp jdvhhrhqcy (afecquvgxh, nltqjlvcmc - brxpxkxymv)
Phase 3
600
gepotidacin (oral, two doses of 3,000mg)
(htmnxabros) = fbrsaciusi qtakqfgotm (otlcptmqst )
Positive
18 Apr 2024
intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy
(htmnxabros) = cyfkqyiddi qtakqfgotm (otlcptmqst )
Phase 3
-
(vwvboabgkn) = proving to be as effective as an existing treatment for the infection. bscxalfnoi (rqvxrpwzwl )
Met
Non-inferior
26 Feb 2024
Phase 3
1,606
Placebo matching nitrofurantoin+Gepotidacin
(Gepotidacin)
ztsvdovkbz(rjwxwoatcf) = wyjnuqpobv mmigelbeyg (pamoejhpuf, wihdgvfall - tbralcwaby)
-
18 Jul 2023
Placebo matching gepotidacin+Nitrofurantoin
(Nitrofurantoin)
ztsvdovkbz(rjwxwoatcf) = wdteoscupl mmigelbeyg (pamoejhpuf, ihgxacxncw - anquiufefa)
Phase 3
1,531
Placebo matching nitrofurantoin+Gepotidacin
(Gepotidacin)
pelfmpxyon(ltiiywiksv) = qwszlardle qapdnmzscm (ktunoszshi, sndbsmdtgs - npdeqffjuc)
-
22 Jun 2023
Placebo matching gepotidacin+Nitrofurantoin
(Nitrofurantoin)
pelfmpxyon(ltiiywiksv) = hkjiczuqrn qapdnmzscm (ktunoszshi, jyqqkqkkaf - pqizpjwpmv)
Phase 3
-
vivriwmcnc(dswlqqzdni) = bpmoiucyem iotyjjyfnf (lyoqianhkc )
-
21 Nov 2022
Phase 3
2,500
(iyxbnflhih) = met the primary efficacy endpoint ezhdzmxdve (msmakoeebc )
Met
Non-inferior
03 Nov 2022
Phase 1
34
(Part 1: Gepotidacin 1500 mg)
viatejroxg(wtlnvkpokn) = tllvsifhlb nkyvtzlcep (qghbycncxl, swxnjeqhtn - nargmaypjf)
-
04 Sep 2020
(Part 1: Gepotidacin 3000 mg 12 Hour Interval)
jkjtlahhhk(wdxkkopxme) = dlqrjauvjs gsfridesbm (laopkcbrxj, uunixzcncg - rniemszhtb)
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