Drugs / Ceftobiprole

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Refused (EMA) EU (EMA) Zeftera (previously Zevtera) 2010-09-16 europa.eu

Trials 15 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 19 trials
Phase 1 NCT06808646 Jan → Feb 2025 Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT00771524 Apr 2009 → Feb 2010 Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT00965042 Apr → May 2009 Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT00770978 Nov 2008 → Sep 2010 Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT00771719 Oct 2008 → Nov 2009 Basilea Pharmaceutica Terminated No outcome recorded
Phase 1 NCT01026558 Aug → Nov 2007 obesity disorder, staphylococcal infection, streptococcal infection Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT01026636 Aug 2007 → Apr 2010 staphylococcal infection, streptococcal infection Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT01026740 Jun → Sep 2007 staphylococcal infection, streptococcal infection Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT01030731 May → Aug 2007 staphylococcal infection, streptococcal infection Basilea Pharmaceutica Completed No outcome recorded
Phase 21 trial
Phase 2 NCT00505258 ? → Apr 2009 bacterial infectious disease Basilea Pharmaceutica Withdrawn No outcome recorded
Phase 34 trials
Phase 3 NCT05856227 Aug 2023 → Dec 2024 neonatal sepsis Basilea Pharmaceutica Completed No outcome recorded
Phase 3 NCT00529282 Oct 2007 → Jan 2008 Pseudomonas infection, gram-positive bacterial infections, neutropenia Basilea Pharmaceutica Terminated No outcome recorded
Phase 3 NCT00229008 Nov 2005 → May 2007 pneumonia Basilea Pharmaceutica Completed No outcome recorded
Phase 3 NCT00210964 Apr 2005 → May 2007 pneumonia Basilea Pharmaceutica Completed No outcome recorded
Phase not applicable1 trial
NCT04171674 Apr 2021 → Jan 2023 pneumonia Nîmes University Hospital Completed No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as ceftobiprole ClinicalTrials.gov intervention name — accepted as the source's own label NCT06808646
14

NCT00505258

NCT01026636

NCT04171674

NCT01030731

NCT05856227

NCT00771719

NCT00210964

NCT01026740

NCT00965042

NCT00529282

NCT00229008

NCT00770978

NCT01026558

NCT00771524

Known as ceftobiprole medocaril “This was a multicenter, open-label, single-arm, multiple-dose study of intravenous (IV) ceftobiprole medocaril (prodrug of the active moiety ceftobiprole).” NCT05856227
3

Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus aureus) activity.” NCT00505258

Ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole” NCT00210964

“Ceftobiprole, the active moiety of ceftobiprole medocaril, is a novel broad-spectrum cephalosporin” PMID 24723282 Apr 2014

Action Inhibit “This study assessed whether there was an inhibitory effect of ceftobiprole on hepatic organic anion-transporting polypeptide 1B (OATP1B) activity.” NCT06808646
Modality Small molecule “Ceftobiprole, the active moiety of ceftobiprole medocaril, is a novel broad-spectrum cephalosporin” PMID 24723282 Apr 2014
Route Intravenous “Patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion” NCT00210964