Drugs / Ceftobiprole medocaril
Ceftobiprole medocaril
also known as
BAL-5788 · BAL-5788-001 · Ceftobiprol medocarilo · CEFTOBIPROLE MEDOCARIL SODIUM · Ceftobiprole medocaril sodium salt · Mabelio · RO 65-5788 · Zevtera
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 7
| 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 Stop: Enrollment |
| Phase 21 trial | ||||||
| Phase 2 | NCT03317093 | Mar 2018 → Oct 2019 | infectious meningitis | Centre Hospitalier Universitaire Dijon | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT03137173 | Feb 2018 → Apr 2019 | — | Basilea Pharmaceutica | Completed | Met primary |
| 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 | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 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. |
| 2022-06-28 | Basilea Pharmaceutica | Results Basilea announces positive results of phase 3 ERADICATE study with ceftobiprole in Staphylococcus aureus bacteremia (SAB) basilea.com ↗
The overall success rate was 69.8% with ceftobiprole compared to 68.7% with daptomycin, with or without aztreonam. |
| 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 |
| 2013-04-29 | Basilea Pharmaceutica | Results Basilea reports presentation of new data on anti-infective drug candidates addressing drug resistance basilea.com ↗
The data presented at ECCMID on the antifungal isavuconazole and the two antibiotics ceftobiprole and BAL30072 further substantiate the promising profiles of these innovative product candidates for addressing high unmet medical need. |
All press releases naming this drug 42 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ceftobiprole Medocaril | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03317093 ↗ |
| Known as | BAL-5788 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1652606 ↗ |
| Known as | BAL-5788-001 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1652606 ↗ |
| Known as | Ceftobiprol medocarilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1652606 ↗ |
| Known as | CEFTOBIPROLE MEDOCARIL SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL1652606 ↗ |
| Known as | Ceftobiprole medocaril sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1652606 ↗ |
| Known as | Mabelio | “500 mg of Mabelio (Ceftobiprole Medocaril) perfused for 2 hours at D0” NCT03317093 ↗ |
| Known as | RO 65-5788 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1652606 ↗ |
| Known as | Zevtera | ChEMBL registry synonym — accepted as the source's own label CHEMBL1652606 ↗ |
| 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 ↗ |