Drugs / Ceftobiprole medocaril
Ceftobiprole medocaril
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ZEVTERA | — | 2024-04-03 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Zeftera (previously Zevtera) | — | 2010-09-16 | europa.eu ↗ |
Trials 8 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02527681 | Nov 2016 → Feb 2020 | bacterial infectious disease | Basilea Pharmaceutica | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03317093 | Mar 2018 → Oct 2019 | infectious meningitis | Centre Hospitalier Universitaire Dijon | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT03138733 | Aug 2018 → Mar 2022 | staphylococcus aureus infection | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT03137173 | Feb 2018 → Apr 2019 | — | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT03439124 | Nov 2017 → Mar 2020 | bacterial pneumonia | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT00326287 | Jun 2006 → Jul 2007 | pneumonia | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT00210899 | Sep 2005 → Oct 2006 | skin disease caused by bacterial infection, staphylococcal infection | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT00228982 | Oct 2004 → Dec 2005 | skin disease caused by bacterial infection, skin infection, staphylococcal infection | Basilea Pharmaceutica | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ceftobiprole medocaril | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03138733 ↗ |
| Known as | Ceftobiprole | “Ceftobiprole is a cephalosporin that may be effective for treating complicated Staphylococcus aureus bacteremia” PMID 37754204 ↗ Sep 2023 |
| Known as | Mabelio | “500 mg of Mabelio (Ceftobiprole Medocaril) perfused for 2 hours at D0” NCT03317093 ↗ |
| Modality | Small molecule | “Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity.” NCT00210899 ↗ |
| Route | Intravenous | “Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d” NCT00326287 ↗ |