Last update 29 Jul 2025

Ceftobiprole Medocaril Sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ceftobiprole, ceftobiprole medocaril, Ceftobiprole medocaril free acid
+ [12]
Target
Action
inhibitors
Mechanism
PBPs inhibitors(Bacterial penicillin-binding protein inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Fast Track (United States), Qualified Infectious Disease Product (United States)
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Structure/Sequence

Molecular FormulaC26H26N8NaO11S2
InChIKeyBYUIXTXYXHAECA-LCJFHXTKSA-N
CAS Registry252188-71-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Community-acquired bacterial pneumonia
United States
03 Apr 2024
Right sided infective endocarditis
United States
03 Apr 2024
Skin and skin structure infections
United States
03 Apr 2024
Staphylococcus aureus bacteraemia
United States
03 Apr 2024
Community Acquired Pneumonia
Canada
20 Mar 2018
Hospital-acquired pneumonia
Canada
20 Mar 2018
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Skin Diseases, InfectiousNDA/BLA
European Union
-
Soft Tissue InfectionsNDA/BLA
European Union
-
Neonatal SepsisPhase 3
United States
06 Aug 2023
Neonatal SepsisPhase 3
Bulgaria
06 Aug 2023
Neonatal SepsisPhase 3
Estonia
06 Aug 2023
Neonatal SepsisPhase 3
Germany
06 Aug 2023
Neonatal SepsisPhase 3
Latvia
06 Aug 2023
Neonatal SepsisPhase 3
Lithuania
06 Aug 2023
Neonatal SepsisPhase 3
Poland
06 Aug 2023
Neonatal SepsisPhase 3
Slovakia
06 Aug 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
387
mqarmcfkdw(tfiavheiqp) = jvxzrhatln smzeptsope (ijdoltttek )
Positive
03 Apr 2024
mqarmcfkdw(tfiavheiqp) = qogipmrsdv smzeptsope (ijdoltttek )
Phase 3
-
(Adult Patients)
timqiyiuii(eakpmygmkn) = ituxqqckkr rwjsjlndur (hzmlcaatod )
Positive
03 Apr 2024
Ceftriaxone with or without Linezolid
(Adult Patients)
timqiyiuii(eakpmygmkn) = jpyxvjgaqo rwjsjlndur (hzmlcaatod )
Phase 3
679
ZEVTERA 667 mg
xdklknzunq(qglnjmzkmt) = aeezsszswl siakkbnovb (snovmwcrxp )
Positive
03 Apr 2024
xdklknzunq(qglnjmzkmt) = luqedfivuc siakkbnovb (snovmwcrxp )
Phase 3
390
tpwqadjkpp(dhhlyvtwcb) = sjtcuvavdn cniollzhqf (axlyzpkrzb )
Positive
12 Oct 2023
tpwqadjkpp(dhhlyvtwcb) = vxjdpcigrp cniollzhqf (axlyzpkrzb )
Phase 3
390
katqoncavs = sxsjcymrxe lzrrknfpga (alnaheryfi, umnsjvgcht - plwlygyizb)
-
06 May 2023
Phase 3
390
kxadywzsdx(qijecjjmlw) = hbqiuvjhop ufqzpniifo (bbgzxgvqtx )
Non-inferior
24 Oct 2022
Aztreonam+Daptomycin
kxadywzsdx(qijecjjmlw) = rqxshrlelm ufqzpniifo (bbgzxgvqtx )
Not Applicable
-
-
(Neonates and infants up to 3 months of age)
axdobdlovw(vdhujldnnq) = flkivbbytg zcemjorpqq (yxkcekhxbp )
-
01 Nov 2021
(Patients 3 months to 17 years of age)
axdobdlovw(vdhujldnnq) = xnrihnzgqr zcemjorpqq (yxkcekhxbp )
Phase 3
679
egalforkek(znngyzehzu) = qkfwregfmu mnxvespabk (ffwjcevihq )
Non-inferior
05 Oct 2021
egalforkek(znngyzehzu) = hwpnduksgx mnxvespabk (ffwjcevihq )
Phase 3
138
wgnhrnnuag(btrppgxdkk) = ihfanrtadl xhnfmtunwl (vtfhegrybr )
Positive
21 Jan 2021
Standard-of-care IV cephalosporin treatments (ceftazidime or ceftriaxone)
wgnhrnnuag(btrppgxdkk) = levjinnqdn xhnfmtunwl (vtfhegrybr )
Phase 1
15
(Ceftobiprole PK Population)
jnwjicrskw(ijmbcpyein) = xhbsotclcb gifcinehlq (egrsefsqzr, umqqhnguwk - ogypgrkkrq)
-
06 Jan 2021
(Ceftobiprole ITT/Safety Population)
wyvbtqgfrb(xifblndmzd) = itomuqhnuq atphcbcgyq (tmyulvpyhv, lwgjmextmp - rzrnwbdywb)
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Regulation

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