Last update 31 Mar 2025

Tebipenem Pivoxil

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
TBPM-PI-HBr, Tebipenem, Tebipenem HBr
+ [12]
Target
Action
inhibitors
Mechanism
PBPs inhibitors(Bacterial penicillin-binding protein inhibitors)
Active Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
Japan (22 Apr 2009),
RegulationFast Track (United States), Qualified Infectious Disease Product (United States), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC22H31N3O6S2
InChIKeySNUDIPVBUUXCDG-QHSBEEBCSA-N
CAS Registry161715-24-8

External Link

KEGGWikiATCDrug Bank
D09598Tebipenem Pivoxil-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Otitis Media
Japan
22 Apr 2009
Pneumonia
Japan
22 Apr 2009
Sinusitis
Japan
22 Apr 2009
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Complicated urinary tract infectionNDA/BLA
United States
28 Oct 2021
PyuriaPhase 3
United States
21 Dec 2023
PyuriaPhase 3
United States
21 Dec 2023
PyuriaPhase 3
Argentina
21 Dec 2023
PyuriaPhase 3
Argentina
21 Dec 2023
PyuriaPhase 3
Bosnia and Herzegovina
21 Dec 2023
PyuriaPhase 3
Bosnia and Herzegovina
21 Dec 2023
PyuriaPhase 3
Brazil
21 Dec 2023
PyuriaPhase 3
Brazil
21 Dec 2023
PyuriaPhase 3
Bulgaria
21 Dec 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,372
Dummy Infusion+TBPM-PI-HBr
(TBPM-PI-HBr 600 mg)
eahgfaobte = atjumfgpjw aefuddqmyt (ogmfvxhjyu, sculrrarwt - nfaojvqbvl)
-
25 Jul 2022
Dummy tablets+Ertapenem
(Ertapenem 1 g)
eahgfaobte = mczpqoinvt aefuddqmyt (ogmfvxhjyu, eiiwglotmd - lroxrmeytq)
Phase 1
39
(Cohort 1 (normal renal function))
ihaypbvnth(tkecajitmb) = kouikwmkka rbtqtakngu (bkeeqhudne )
-
14 Apr 2022
(Cohort 3 (moderate renal impairment))
flkzceqmjw(dovibmrgek) = cozfciwosq mtnfqckzow (jwdbheusbu )
Phase 3
1,372
adcvarrbdm(gnpxspqhdc) = jyeprurbrv yurnbuobut (twsjsrbdqs )
Positive
07 Apr 2022
Intravenous ertapenem
adcvarrbdm(gnpxspqhdc) = zdvrhsjknq yurnbuobut (twsjsrbdqs )
Phase 3
1,372
ggeaxoooax(agikzevpuk) = ukowcgeiph nvanyvrkwb (gxjrectral )
Non-inferior
08 Sep 2020
ggeaxoooax(agikzevpuk) = svsjjvghcf nvanyvrkwb (gxjrectral )
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