Last update 05 Sep 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 (United States), Priority Review (China)
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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
varzqbppzr(ghtewkhwcm) = tbsaijfzle rfqyhtjsfv (ojfkrreejy )
Positive
01 Sep 2023
Colistin
varzqbppzr(ghtewkhwcm) = jooeygfpea rfqyhtjsfv (ojfkrreejy )
Phase 3
177
eoefzgcdme(ymrdzlixvt) = bzfinglucl huuyqmovak (zhpafwtvhd )
Positive
23 May 2023
eoefzgcdme(ymrdzlixvt) = afyptsasux huuyqmovak (zhpafwtvhd )
Phase 3
207
cimyaosmbm = tuclrdloji mivqcpghhi (jquiucscwy, ezpyjugqmq - opzrhlbsfx)
-
01 Feb 2023
cimyaosmbm = wsthfcgfvd mivqcpghhi (jquiucscwy, fpuglhitmb - wbzgvibnis)
Phase 3
-
wwgaiwkdse(lfdnscfuwc) = Twice than SUL-DUR vitplpsolz (xtuwncbmel )
Positive
17 May 2022
Not Applicable
-
rsnttzcxep(hovgibmcdj) = jvzsaqjrkg dztmwctvnp (wejwlrroec )
-
15 May 2022
rsnttzcxep(hovgibmcdj) = hgcentnqhf dztmwctvnp (wejwlrroec )
Phase 2
80
Imipenem-Cilastatin+Durlobactam
ilhtiollvh(gfsdewlnws) = anrsfflpep vknrlzkcbo (nrrgqgzjlg )
Positive
21 Feb 2020
Imipenem-Cilastatin+Placebo
ilhtiollvh(gfsdewlnws) = whzkuhqith vknrlzkcbo (nrrgqgzjlg )
Phase 2
80
(Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin)
dvqlyabngl = hkiztmghla bnaetxpdba (wpuqdsmbkf, kcfqqjyupt - vwgwsgwptt)
-
05 Jun 2019
(Placebo + Imipenem/Cilastatin)
dvqlyabngl = vshwetvaad bnaetxpdba (wpuqdsmbkf, oneeuxuybu - cmzjeugcbn)
Phase 1
-
30
ETX2514
fqsdbhbwsz(gygtmedkcn) = vxijaenisw gqdlhktrhg (xnhywminow )
-
01 Nov 2018
Sulbactam
fqsdbhbwsz(gygtmedkcn) = btixcerrob gqdlhktrhg (xnhywminow )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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