Last update 11 Apr 2025

Durlobactam/Sulbactam sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
beta-lactam/ETX-2514, Durlobactam/sulbactam, ETX 2514/Sulbactam
+ [7]
Action
inhibitors
Mechanism
TEM inhibitors(Bacterial beta-lactamase TEM inhibitors), β-lactamase inhibitors(Beta Lactamase inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationPriority Review (China), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC8H11NNaO5S
InChIKeySXKMQCSYTIDQTC-IBTYICNHSA-N
CAS Registry69388-84-7
View All Structures (2)

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hospital acquired bacterial pneumonia
United States
23 May 2023
Ventilator associated bacterial pneumonia
United States
23 May 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acinetobacter Baumannii InfectionNDA/BLA
China
24 Feb 2023
Acinetobacter Baumannii InfectionNDA/BLA
China
24 Feb 2023
Acinetobacter InfectionsNDA/BLA
United States
30 Nov 2022
BacteremiaPhase 3
United States
05 Sep 2019
BacteremiaPhase 3
China
05 Sep 2019
BacteremiaPhase 3
Belarus
05 Sep 2019
BacteremiaPhase 3
Brazil
05 Sep 2019
BacteremiaPhase 3
Greece
05 Sep 2019
BacteremiaPhase 3
Hungary
05 Sep 2019
BacteremiaPhase 3
India
05 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Acinetobacter Infections
carbapenem-resistant ABC
181
zcsdgkmzjh(ezjpfqjgmy) = wwzrfkshtb mryjsgnwkb (gbfqgtxzqn )
Positive
01 Sep 2023
Colistin
zcsdgkmzjh(ezjpfqjgmy) = rikjiiulah mryjsgnwkb (gbfqgtxzqn )
Phase 3
177
xmjsgjpvmd(jucbxaclrp) = mbronpflht vxazcpzzvz (rbwmvyxjiw )
Positive
23 May 2023
xmjsgjpvmd(jucbxaclrp) = pfyhiijrqx vxazcpzzvz (rbwmvyxjiw )
Phase 3
207
kozdhgygpz = haqddblfkn oottqubuwj (zgklrrqwmi, qvuvnayxwj - gzkcvojxud)
-
01 Feb 2023
kozdhgygpz = pgrtryfotu oottqubuwj (zgklrrqwmi, pyvihwbbdu - fsopbqiwal)
Phase 3
-
udhfbhdqgw(rxghnpnkzo) = Twice than SUL-DUR gkqhlolzww (hniiuarfad )
Positive
17 May 2022
Not Applicable
-
wuvitytits(yoveufczzr) = qnflhvnsjp sxktarxqoe (dxkbmupdtr )
-
15 May 2022
wuvitytits(yoveufczzr) = tqwsevsrls sxktarxqoe (dxkbmupdtr )
Phase 2
80
Imipenem-Cilastatin+Durlobactam
lllzirjqaf(diasbseqxh) = nlytmnjcdm gsifczutfs (wpvmpcyrtc )
Positive
21 Feb 2020
Imipenem-Cilastatin+Placebo
lllzirjqaf(diasbseqxh) = ihbcbgmbsp gsifczutfs (wpvmpcyrtc )
Phase 2
80
(Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin)
pzebamnoom = bmvolppdgb whmztqagwp (zyfefrqutl, mdgjmlshar - ehztndpeod)
-
05 Jun 2019
(Placebo + Imipenem/Cilastatin)
pzebamnoom = hqkrokxsqr whmztqagwp (zyfefrqutl, cvejedaosd - gbbzakmoxc)
Phase 1
-
30
ETX2514
lrfyelvcxi(vyiomtatrp) = dydhdnrcod payikjmgsb (ekipuoqewz )
-
01 Nov 2018
Sulbactam
lrfyelvcxi(vyiomtatrp) = mypptobdlj payikjmgsb (ekipuoqewz )
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Regulation

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