Drugs / Ceftobiprole
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pneumonia 2 milestones | |||||
| Filed | Other | — | pneumonia | 2013-09-16 | “Swiss regulatory authority Swissmedic has accepted the ceftobiprole Marketing Authorization Application for review.” basilea.com ↗ |
| Filed | EU (EMA) | — | pneumonia | — | “Basilea submitted a Marketing Authorization Application in Europe for the treatment of pneumonia which was accepted for review in October 2012.” basilea.com ↗ |
| Filed staphylococcus aureus pneumonia 1 milestone | |||||
| Filed | US (FDA) | — | staphylococcus aureus pneumonia | 2023-08-03 | “In early August, we submitted the New Drug Application for ceftobiprole to the US Food and Drug Administration” basilea.com ↗ “In August, Basilea submitted a New Drug Application (NDA) to the FDA, seeking approval of ceftobiprole” basilea.com ↗ |
| Rejected Indication not stated 1 milestone | |||||
| Refused (EMA) | EU (EMA) | Zeftera (previously Zevtera) | — | 2010-09-16 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT06808646 | Jan → Feb 2025 | — | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 1 | NCT00965042 | Apr → May 2009 | — | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 1 | NCT00771524 | Apr 2009 → Feb 2010 | — | 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 Stop: Enrollment |
| 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 35 trials · 1 met primary | ||||||
| Phase 3 | NCT05856227 | Aug 2023 → Dec 2024 | neonatal sepsis | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT03138733 | Aug 2018 → Mar 2022 | staphylococcus aureus infection | Basilea Pharmaceutica | Completed | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2024-05-03 | Basilea Pharmaceutica | Results Basilea reports presentation of new data for ceftobiprole (Zevtera®) at ESCMID Global 2024 basilea.com ↗
Using the FDA-CABP-2020 primary endpoint of early clinical success at day 3 after study start, this re-analysis supported the non-inferiority of ceftobiprole to ceftriaxone ± linezolid. |
| 2024-04-04 | Basilea Pharmaceutica | Regulatory Basilea announces US FDA approval of antibiotic ZEVTERA® (ceftobiprole medocaril) for three indications basilea.com ↗
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the US Food and Drug Administration (FDA) approved ZEVTERA® (ceftobiprole medocaril sodium for injection), for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). |
| 2023-10-17 | Basilea Pharmaceutica | Results Basilea reports new data for ceftobiprole (Zevtera®) presented at US IDWeek Congress 2023 basilea.com ↗
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that scientific presentations with new data on its antibiotic ceftobiprole (Zevtera®) have been presented at Infectious Disease Week (IDWeek) 2023, highlighting its utility for the treatment of severe bacterial infections. |
| 2023-10-02 | Basilea Pharmaceutica | Regulatory Basilea announces FDA acceptance of New Drug Application for antibiotic ceftobiprole basilea.com ↗
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the antibiotic ceftobiprole, which was submitted to the FDA on August 3rd this year. |
| 2023-09-28 | Basilea Pharmaceutica | Results Basilea announces New England Journal of Medicine publication of phase 3 data on ceftobiprole for the treatment of Staphylococcus aureus bacteremia basilea.com ↗
Using a pre-defined non-inferiority margin of 15%, treatment with ceftobiprole was non-inferior to daptomycin with overall treatment success achieved in 69.8% of patients in the ceftobiprole group compared to 68.7% in the daptomycin group. |
| 2023-08-04 | Basilea Pharmaceutica | Regulatory Basilea announces submission of a New Drug Application to the US Food and Drug Administration for its antibiotic ceftobiprole basilea.com ↗
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA). |
| 2022-10-24 | Basilea Pharmaceutica | Results ERADICATE phase 3 study results highlight the potential role of ceftobiprole in the treatment of Staphylococcus aureus bacteremia (SAB) basilea.com ↗
As presented at IDWeek, ceftobiprole met the primary endpoint by demonstrating non-inferiority versus daptomycin, with or without aztreonam. |
| 2022-10-13 | Basilea Pharmaceutica | Results Basilea announces late breaking presentation on the successfully completed ERADICATE phase 3 study with ceftobiprole in Staphylococcus aureus bacteremia (SAB) at IDWeek 2022 basilea.com ↗
The positive results underline the potent activity of ceftobiprole for treating serious bacterial infections and enable us to proceed with an NDA submission of ceftobiprole in the U.S. |
| 2022-07-12 | Basilea Pharmaceutica | Regulatory Basilea announces Zevtera® (ceftobiprole) marketing authorization in Brazil basilea.com ↗
Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company, announced today that its distribution partner for Latin America, Knight Therapeutics Inc. (“Knight”, TSX: GUD), has received a marketing authorization from the Agência Nacional de Vigilância Sanitária (Anvisa) in Brazil for the broad-spectrum, anti-MRSA (methicillin-resistant Staphylococcus aureus) antibiotic Zevtera® (ceftobiprole). |
| 2022-06-28 | Basilea Pharmaceutica | Results Basilea announces positive results of phase 3 ERADICATE study with ceftobiprole in Staphylococcus aureus bacteremia (SAB) basilea.com ↗
Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company, announced today positive topline results for the phase 3 ERADICATE study, evaluating ceftobiprole in the treatment of adult patients with bacterial bloodstream infections caused by Staphylococcus aureus (SAB). |
| 2020-11-06 | Basilea Pharmaceutica | Regulatory Basilea announces approval of antibiotic Zevtera® in China to treat community-acquired pneumonia and hospital-acquired pneumonia basilea.com ↗
With the Drug Approval License Authorization, Zevtera is now approved in China for the treatment of adult patients with community-acquired pneumonia (CAP) and adult patients with hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP). |
| 2020-05-28 | Basilea Pharmaceutica | Regulatory Basilea provides corporate update basilea.com ↗
FDA approves protocol amendment for the phase 3 ERADICATE bacteremia study with ceftobiprole to include a broader spectrum of severely ill patients |
| 2019-08-06 | Basilea Pharmaceutica | Results Basilea announces positive results of phase 3 TARGET study with antibiotic ceftobiprole in the treatment of acute bacterial skin and skin structure infections (ABSSSI) basilea.com ↗
Ceftobiprole met the pre-specified primary efficacy objective of non-inferiority (within the pre-specified margin of 10%) to vancomycin plus aztreonam in the intent-to-treat (ITT) population. |
| 2017-12-21 | Basilea Pharmaceutica | Regulatory Basilea reports that ceftobiprole received QIDP designation from U.S. FDA for the treatment of Staphylococcus aureus bacteremia (SAB) basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) designated its investigational drug ceftobiprole as a Qualified Infectious Disease Product (QIDP). |
| 2017-04-21 | Basilea Pharmaceutica | Regulatory Basilea announces agreement with FDA on Special Protocol Assessments for antibiotic ceftobiprole phase 3 clinical studies in bloodstream and skin infections basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that it has reached agreement with the US Food and Drug Administration (FDA) on Special Protocol Assessments (SPAs) for its two planned phase 3 clinical studies of Basilea's antibiotic ceftobiprole. |
| 2016-04-15 | Basilea Pharmaceutica | Results Basilea reports presentation of isavuconazole and ceftobiprole data at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) basilea.com ↗
The data demonstrated that clinical responses with ceftobiprole were similar to those for standard-of-care comparators, with a trend towards lower 30-day all-cause mortality with ceftobiprole. |
| 2015-10-12 | Basilea Pharmaceutica | Regulatory Basilea announces that Health Canada approved ZEVTERA® for the treatment of bacterial lung infections basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that Health Canada has approved ZEVTERA® (ceftobiprole medocaril) for the treatment of patients 18 years of age and older with hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP), and for the treatment of community-acquired pneumonia (CAP). |
| 2015-08-12 | Basilea Pharmaceutica | Regulatory Basilea reports that ceftobiprole received QIDP designation from U.S. FDA for the treatment of lung and skin infections basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) designated its investigational drug ceftobiprole as a Qualified Infectious Disease Product. |
| 2014-12-22 | Basilea Pharmaceutica | Regulatory Swissmedic approves Basilea's antibiotic Zevtera® (ceftobiprole medocaril) for the treatment of pneumonia basilea.com ↗
Basel, Switzerland, December 22, 2014 - Basilea Pharmaceutica Ltd. (SIX: BSLN) reports that the Swiss regulatory authority Swissmedic has approved the antibiotic Zevtera® (ceftobiprole medocaril) for the treatment in adults of community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP). |
| 2014-06-25 | Basilea Pharmaceutica | Regulatory Basilea provides update on ceftobiprole's U.S. regulatory status basilea.com ↗
The FDA confirmed that the current ceftobiprole studies should be complemented with prospective data in community and hospital-acquired pneumonia in accordance with its new guidelines. |
| 2014-05-13 | Basilea Pharmaceutica | Results Basilea presents new data on its antibiotics pipeline at ECCMID basilea.com ↗
Phase 3 data analyses were presented that demonstrated more rapid clinical responses in HAP and CAP patients treated with ceftobiprole than with the comparator regimen. |
| 2013-10-23 | Basilea Pharmaceutica | Regulatory Basilea's antibiotic ceftobiprole obtains regulatory approval in Europe for pneumonia basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today the approval of its antibiotic ceftobiprole in Europe. |
| 2013-09-16 | Basilea Pharmaceutica | Regulatory Swissmedic accepts for review Basilea's ceftobiprole Marketing Authorization Application for the treatment of pneumonia basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the Swiss regulatory authority Swissmedic has accepted the ceftobiprole Marketing Authorization Application for review. |
| 2013-09-13 | Basilea Pharmaceutica | Results Basilea reports presentation of 19 posters at ICAAC on investigational anti-infectives isavuconazole, ceftobiprole, and BAL30072 basilea.com ↗
A presentation showing a genotypic characterization of methicillin-resistant Staphylococcus aureus (MRSA) strains collected during the ceftobiprole pneumonia phase 3 studies confirmed that the isolates were representative |
All press releases naming this drug 51 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ceftobiprole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00210964 ↗ |
| 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 ↗ |