Drugs / Ceftaroline fosamil
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | TEFLARO | — | 2015-08-31 – 2019-09-13 | fda.gov ↗ |
| Approved | EU (EMA) | Zinforo | — | 2012-08-22 | europa.eu ↗ |
| Approved | US (FDA) | TEFLARO | — | 2010-10-29 | fda.gov ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT01789528 | Aug 2013 → Mar 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01664065 | Feb → Nov 2013 | kidney disorder | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01612507 | Jul → Nov 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01624246 | May 2012 → Mar 2013 | — | Forest Laboratories | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02335905 | Jun 2015 → Jun 2020 | osteomyelitis | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02424734 | Aug 2015 → Dec 2017 | neonatal sepsis | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01281462 | Dec 2010 → Mar 2012 | urinary tract infection | Forest Laboratories | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT01530763 | Sep 2012 → Apr 2014 | infectious disease | Forest Laboratories | Completed | No outcome recorded |
| Phase 2/3 | NCT01400867 | Dec 2011 → May 2014 | primary bacterial infectious disease | Forest Laboratories | Completed | No outcome recorded |
| Phase 35 trials · 3 met primary | ||||||
| Phase 3 | NCT02202135 | Jun 2014 → Jan 2015 | — | Pfizer | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT01499277 | May 2012 → Jun 2014 | necrotizing soft tissue infection | Pfizer | Completed | Met primary |
| Phase 3 | NCT01371838 | Dec 2011 → May 2013 | bacterial pneumonia | Pfizer | Completed | Met primary |
| Phase 3 | NCT00621504 | Jan → Dec 2008 | bacterial pneumonia | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT00509106 | Jul 2007 → Aug 2008 | bacterial pneumonia | Forest Laboratories | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT01701219 | Jan 2013 → May 2014 | methicillin-resistant staphylococcus aureus infectious disease | Forest Laboratories | Completed | No outcome recorded |
| Phase 4 | NCT01666743 | Nov 2012 → Sep 2013 | bacterial pneumonia | Forest Laboratories | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01669980 | Oct 2012 → May 2014 | pneumonia | Forest Laboratories | Completed | No outcome recorded |
| Phase 4 | NCT01645735 | Oct 2012 → Dec 2013 | respiratory tract infectious disorder | Forest Laboratories | Completed | No outcome recorded |
| Phase 4 | NCT01298843 | Apr 2011 → Feb 2013 | infectious disease | Forest Laboratories | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2012-08-28 | AstraZeneca | Regulatory European Commission approves ZINFORO™ (ceftaroline fosamil) for adult patients with serious skin infections or community acquired pneumonia astrazeneca.com ↗
AstraZeneca today announced that the European Commission has granted Marketing Authorisation to ZINFORO™ (ceftaroline fosamil), a new intravenous cephalosporin antibiotic, for the treatment of adult patients with complicated Skin and Soft Tissue Infections (cSSTI) or Community Acquired Pneumonia (CAP). |
| 2012-06-22 | AstraZeneca | Regulatory Zinforo (ceftaroline fosamil) receives positive CHMP opinion in the European Union for the treatment of patients with serious skin infections or community acquired pneumonia astrazeneca.com ↗
The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. |
All press releases naming this drug 2 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ceftaroline fosamil | “Efficacy of ceftaroline fosamil, the prodrug of the active metabolite ceftaroline, was demonstrated in a phase 3 study of hospitalized Asian patients” PMID 31044546 ↗ May 201918“Cohort 2: CXL (600 mg ceftaroline fosamil and 600 mg avibactam)” NCT01789528 ↗ |
| Known as | Ceftaroline | “Ceftaroline Fosamil (Ceftaroline), which fights infections like the one the subject has.” NCT02335905 ↗1“IV ceftaroline 600mg every 8 hours” NCT01499277 ↗ |
| Modality | Other / unclassified | “broad-spectrum cephalosporin antibiotic” PMID 27093162 ↗ Jul 2016 |
| Route | Intravenous | “Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).” NCT00509106 ↗ |