Drug

Ceftaroline fosamil

Approved · EMA

Late-stage development

Also known as Teflaro, Ceftarolina fosamilo, Ceftarolinum fosamilum.

RxNorm1040004 ChEMBLCHEMBL501122UNII7P6FQA5D21

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection: An Open Label Individual Patient Study

Clinical trial2026-06-03Results expected Q4 2027 · ClinicalTrials.gov

Phase 1/2 Trial of Ceftaroline for the Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children

Clinical trial2021-11-02Results posted · ClinicalTrials.gov

Open-label, Multicentre Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Ceftaroline In Neonates And Young Infants With Late-onset Sepsis

Clinical trial2017-12-26Terminated · ClinicalTrials.gov

A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

Clinical trial2017-09-06Results posted · ClinicalTrials.gov

Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftaroline in Patients With CSF Device

Clinical trial2016-10-24Completed · ClinicalTrials.gov

A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects With Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus Aureus

Clinical trial2016-02-01Results posted · ClinicalTrials.gov

A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) vs Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities.

Clinical trial2015-01-01Terminated · ClinicalTrials.gov

A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)

Clinical trial2014-08-01Completed · ClinicalTrials.gov

A Multicenter, 2-Cohort Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia

Clinical trial2014-07-01Completed · ClinicalTrials.gov

A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization

Clinical trial2014-07-01Completed · ClinicalTrials.gov

A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

Clinical trial2014-07-01Completed · ClinicalTrials.gov

Approval: Zinforo (EMA)

Regulatory2012-08-22EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Ceftaroline fosamil

Aliases & brands

TeflaroCeftarolina fosamiloCeftarolinum fosamilum

RxNorm CUI

1040004

ChEMBL ID

CHEMBL501122

UNII

7P6FQA5D21

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2012-08-22

Latest approval

2012-08-22

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2012-08-22Approval

Approval: Zinforo (EMA)

Indication: Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults: Complicated skin and soft tissue infections (cSSTI)… Show full indication

Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults: Complicated skin and soft tissue infections (cSSTI) Community-acquired pneumonia (CAP) Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.