Last update 20 Mar 2025

Cilastatin Sodium/Imipenem/Relebactam

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Cilastatin/imipenem/relebactam, Cilastatin/relebactam/imipenem, IMI/REL
+ [14]
Action
inhibitors
Mechanism
Enzymes inhibitors, PBPs inhibitors(Bacterial penicillin-binding protein inhibitors), β-lactamase inhibitors(Beta Lactamase inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
RegulationSpecial Review Project (China), Fast Track (United States), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC12H19N3O5S
InChIKeyGSOSVVULSKVSLQ-JJVRHELESA-N
CAS Registry74431-23-5
View All Structures (3)

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Infectious Diseases
Japan
23 Jun 2021
Hospital acquired bacterial pneumonia
United States
04 Jun 2020
Ventilator associated bacterial pneumonia
United States
04 Jun 2020
Bacteremia
Iceland
13 Feb 2020
Bacteremia
Norway
13 Feb 2020
Bacteremia
Liechtenstein
13 Feb 2020
Bacteremia
European Union
13 Feb 2020
Hospital-acquired pneumonia
Liechtenstein
13 Feb 2020
Hospital-acquired pneumonia
European Union
13 Feb 2020
Hospital-acquired pneumonia
Norway
13 Feb 2020
Hospital-acquired pneumonia
Iceland
13 Feb 2020
Pneumonia, Ventilator-Associated
European Union
13 Feb 2020
Pneumonia, Ventilator-Associated
Liechtenstein
13 Feb 2020
Pneumonia, Ventilator-Associated
Iceland
13 Feb 2020
Pneumonia, Ventilator-Associated
Norway
13 Feb 2020
Complicated intra-abdominal infection
United States
16 Jul 2019
Complicated urinary tract infection
United States
16 Jul 2019
Gram-Negative Bacterial Infections
United States
16 Jul 2019
Pyelonephritis
United States
16 Jul 2019
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hospital acquired bacterial pneumoniaPhase 2
Mexico
18 Sep 2018
Hospital acquired bacterial pneumoniaPhase 2
Russia
18 Sep 2018
Hospital acquired bacterial pneumoniaPhase 2
Philippines
18 Sep 2018
Hospital acquired bacterial pneumoniaPhase 2
Brazil
18 Sep 2018
Hospital acquired bacterial pneumoniaPhase 2
France
18 Sep 2018
Hospital acquired bacterial pneumoniaPhase 2
Romania
18 Sep 2018
Hospital acquired bacterial pneumoniaPhase 2
Ukraine
18 Sep 2018
Complicated intra-abdominal infectionPhase 2
Japan
04 Oct 2017
Complicated urinary tract infectionPhase 2
Japan
04 Oct 2017
Carbapenem Resistant Bacterial InfectionPhase 2-21 Aug 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
8
iccpdgyblt(mxprxwvxds) = fcqyoipaow iomzvitygw (qbuatweiwj, tjeonatkhg - hpwcovxsuo)
-
07 Aug 2024
Phase 3
274
(IMI/REL FDC)
tjgaktdgzw(pfrliyekzu) = bolhgjklmt dxiqukuyav (eauzwagimk, tjztoipbat - hajgcynxas)
-
28 Jun 2023
(PIP/TAZ FDC)
tjgaktdgzw(pfrliyekzu) = nxtqluffcf dxiqukuyav (eauzwagimk, pmyozknlmv - lglkyqmhbf)
Not Applicable
-
qsrjrfxfan(ruaiamwwvc) = Due to leukopenia, abdominal pain, and diarrhea the frequency of imipenem, cilastatin, and relebactam was decreased to twice daily QOD and amoxicillin was decreased to QOD gtfctzzhud (kpktijidco )
-
15 May 2022
Phase 3
47
sjpkzflgss(fdwhnmampx) = akwsfzdkgi mdnjneuriu (hcpgplldnw )
Positive
15 Apr 2020
imipenem+colistin
sjpkzflgss(fdwhnmampx) = umewnlbzxf mdnjneuriu (hcpgplldnw )
Phase 3
50
(Group 1: Imipenem+Cilastatin/Relebactam)
ntuqlkzaiu(tcmihjtwml) = nuadbxwrpd tdgaqunxji (ttbqhhcgxi, lcbfxnxjlc - jqvrvagweg)
-
19 Oct 2018
Imipenem+Cilastatin+Colistimethate sodium (CMS)
(Group 2: Colistimethate Sodium + Imipenem+Cilastatin)
ntuqlkzaiu(tcmihjtwml) = wyzliremij tdgaqunxji (ttbqhhcgxi, gxpkmpaobz - pdkvpntbcw)
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Regulation

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