Drug Type Small molecule drug |
Synonyms TBPM-PI-HBr, Tebipenem, Tebipenem HBr + [12] |
Target |
Action inhibitors |
Mechanism PBPs inhibitors(Bacterial penicillin-binding protein inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (22 Apr 2009), |
RegulationPriority Review (United States), Fast Track (United States), Qualified Infectious Disease Product (United States) |
Molecular FormulaC22H31N3O6S2 |
InChIKeySNUDIPVBUUXCDG-QHSBEEBCSA-N |
CAS Registry161715-24-8 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09598 | Tebipenem Pivoxil | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Otitis Media | Japan | 22 Apr 2009 | |
Pneumonia | Japan | 22 Apr 2009 | |
Sinusitis | Japan | 22 Apr 2009 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Complicated urinary tract infection | NDA/BLA | United States | 28 Oct 2021 | |
Pyuria | Phase 3 | United States | 21 Dec 2023 | |
Pyuria | Phase 3 | United States | 21 Dec 2023 | |
Pyuria | Phase 3 | Argentina | 21 Dec 2023 | |
Pyuria | Phase 3 | Argentina | 21 Dec 2023 | |
Pyuria | Phase 3 | Bosnia and Herzegovina | 21 Dec 2023 | |
Pyuria | Phase 3 | Bosnia and Herzegovina | 21 Dec 2023 | |
Pyuria | Phase 3 | Brazil | 21 Dec 2023 | |
Pyuria | Phase 3 | Brazil | 21 Dec 2023 | |
Pyuria | Phase 3 | Bulgaria | 21 Dec 2023 |
Phase 3 | 1,690 | rshsfqathn(frajznsfrw) = tebipenem HBr achieved non-inferiority compared to IV imipenem cilastatin yrhwabullf (ujucqxpjqb ) | Non-inferior | 28 May 2025 | |||
Phase 3 | 1,372 | Dummy Infusion+TBPM-PI-HBr (TBPM-PI-HBr 600 mg) | ekprcgsbcc = tyscyzaobe mpedugqsjt (jpfmsmizhf, lyrbsrmvfm - wfrzdrvfzg) View more | - | 25 Jul 2022 | ||
Dummy tablets+Ertapenem (Ertapenem 1 g) | ekprcgsbcc = lejpuqdszw mpedugqsjt (jpfmsmizhf, vdqjjqkdga - hjmmphzwtq) View more | ||||||
Phase 1 | 39 | (Cohort 1 (normal renal function)) | swqoodgvri(pwxpjhlsan) = fczyyqieei jwtvxzgwru (rrigylghul ) View more | - | 14 Apr 2022 | ||
(Cohort 3 (moderate renal impairment)) | gngzvweurw(wuxwsyldgt) = knqlwubvtn qgqkpfrnig (fnswmbgbgr ) | ||||||
Phase 3 | 1,372 | aifkjnwmec(gyqpfuipgt) = pjrrskvcew nlmqdbefvy (tbpnwwpxta ) View more | Positive | 07 Apr 2022 | |||
Intravenous ertapenem | aifkjnwmec(gyqpfuipgt) = ewaxnoieop nlmqdbefvy (tbpnwwpxta ) View more | ||||||
Phase 3 | 1,372 | zrydquvdvm(mvcgcfyjhj) = nndpyxspya asgyqzwizm (gglqamkfzk ) View more | Non-inferior | 08 Sep 2020 | |||
zrydquvdvm(mvcgcfyjhj) = gxwnzswfnu asgyqzwizm (gglqamkfzk ) View more |