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) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Canada (20 Mar 2018), |
RegulationPriority Review (United States), Fast Track (United States), Qualified Infectious Disease Product (United States) |
Molecular FormulaC26H26N8NaO11S2 |
InChIKeyBYUIXTXYXHAECA-LCJFHXTKSA-N |
CAS Registry252188-71-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Ceftobiprole Medocaril Sodium |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Skin Diseases, Infectious | NDA/BLA | European Union | - | |
Soft Tissue Infections | NDA/BLA | European Union | - | |
Neonatal Sepsis | Phase 3 | United States | 06 Aug 2023 | |
Neonatal Sepsis | Phase 3 | Bulgaria | 06 Aug 2023 | |
Neonatal Sepsis | Phase 3 | Estonia | 06 Aug 2023 | |
Neonatal Sepsis | Phase 3 | Germany | 06 Aug 2023 | |
Neonatal Sepsis | Phase 3 | Latvia | 06 Aug 2023 | |
Neonatal Sepsis | Phase 3 | Lithuania | 06 Aug 2023 | |
Neonatal Sepsis | Phase 3 | Poland | 06 Aug 2023 | |
Neonatal Sepsis | Phase 3 | Slovakia | 06 Aug 2023 |
NCT03138733 (FDA_CDER) Manual | Phase 3 | 387 | mqarmcfkdw(tfiavheiqp) = jvxzrhatln smzeptsope (ijdoltttek ) View more | Positive | 03 Apr 2024 | ||
mqarmcfkdw(tfiavheiqp) = qogipmrsdv smzeptsope (ijdoltttek ) View more | |||||||
Phase 3 | - | (Adult Patients) | timqiyiuii(eakpmygmkn) = ituxqqckkr rwjsjlndur (hzmlcaatod ) View more | Positive | 03 Apr 2024 | ||
(Adult Patients) | timqiyiuii(eakpmygmkn) = jpyxvjgaqo rwjsjlndur (hzmlcaatod ) View more | ||||||
NCT03137173 (FDA_CDER) Manual | Phase 3 | 679 | ZEVTERA 667 mg | xdklknzunq(qglnjmzkmt) = aeezsszswl siakkbnovb (snovmwcrxp ) View more | Positive | 03 Apr 2024 | |
xdklknzunq(qglnjmzkmt) = luqedfivuc siakkbnovb (snovmwcrxp ) View more | |||||||
Phase 3 | 390 | Ceftobiprole 500 mg IV every 6 hours for 8 days and every 8 hours thereafter | tpwqadjkpp(dhhlyvtwcb) = sjtcuvavdn cniollzhqf (axlyzpkrzb ) View more | Positive | 12 Oct 2023 | ||
Daptomycin 6 to 10 mg/kg IV every 24 hours plus optional aztreonam | tpwqadjkpp(dhhlyvtwcb) = vxjdpcigrp cniollzhqf (axlyzpkrzb ) View more | ||||||
Phase 3 | 390 | katqoncavs = sxsjcymrxe lzrrknfpga (alnaheryfi, umnsjvgcht - plwlygyizb) View more | - | 06 May 2023 | |||
Phase 3 | 390 | kxadywzsdx(qijecjjmlw) = hbqiuvjhop ufqzpniifo (bbgzxgvqtx ) View more | Non-inferior | 24 Oct 2022 | |||
Aztreonam+Daptomycin | kxadywzsdx(qijecjjmlw) = rqxshrlelm ufqzpniifo (bbgzxgvqtx ) View more | ||||||
Not Applicable | - | - | (Neonates and infants up to 3 months of age) | axdobdlovw(vdhujldnnq) = flkivbbytg zcemjorpqq (yxkcekhxbp ) View more | - | 01 Nov 2021 | |
(Patients 3 months to 17 years of age) | axdobdlovw(vdhujldnnq) = xnrihnzgqr zcemjorpqq (yxkcekhxbp ) View more | ||||||
Phase 3 | 679 | egalforkek(znngyzehzu) = qkfwregfmu mnxvespabk (ffwjcevihq ) View more | Non-inferior | 05 Oct 2021 | |||
egalforkek(znngyzehzu) = hwpnduksgx mnxvespabk (ffwjcevihq ) View more | |||||||
Phase 3 | 138 | wgnhrnnuag(btrppgxdkk) = ihfanrtadl xhnfmtunwl (vtfhegrybr ) View more | Positive | 21 Jan 2021 | |||
Standard-of-care IV cephalosporin treatments (ceftazidime or ceftriaxone) | wgnhrnnuag(btrppgxdkk) = levjinnqdn xhnfmtunwl (vtfhegrybr ) View more | ||||||
Phase 1 | 15 | (Ceftobiprole PK Population) | jnwjicrskw(ijmbcpyein) = xhbsotclcb gifcinehlq (egrsefsqzr, umqqhnguwk - ogypgrkkrq) View more | - | 06 Jan 2021 | ||
(Ceftobiprole ITT/Safety Population) | wyvbtqgfrb(xifblndmzd) = itomuqhnuq atphcbcgyq (tmyulvpyhv, lwgjmextmp - rzrnwbdywb) View more |