Overview
Linezolid is a synthetic antibiotic which is used for the treatment of infections caused by aerobic Gram-positive bacteria. Its effects are bacteriostatic against both enterococci and staphylococci and bactericidal against most isolates of streptococci. Linezolid exerts its antibacterial activity by inhibiting the initiation of bacterial protein synthesis - more specifically, it binds to the 23S ribosomal RNA of the 50S subunit and, in doing so, prevents the formation of the 70S initiation complex which is essential for bacterial reproduction. Linezolid was initially approved in 2000 and was the first member of the oxazolidinone antibiotic class. A second member of this class, tedizolid, was approved by the FDA in 2014 and is considered generally more effective and tolerable than its predecessor.
Background
Linezolid is a synthetic antibiotic which is used for the treatment of infections caused by aerobic Gram-positive bacteria. Its effects are bacteriostatic against both enterococci and staphylococci and bactericidal against most isolates of streptococci. Linezolid exerts its antibacterial activity by inhibiting the initiation of bacterial protein synthesis - more specifically, it binds to the 23S ribosomal RNA of the 50S subunit and, in doing so, prevents the formation of the 70S initiation complex which is essential for bacterial reproduction. Linezolid was initially approved in 2000 and was the first member of the oxazolidinone antibiotic class. A second member of this class, tedizolid, was approved by the FDA in 2014 and is considered generally more effective and tolerable than its predecessor.
Indication
Linezolid is indicated in adults and children for the treatment of infections caused by susceptible Gram-positive bacteria, including nosocomial pneumonia, community-acquired pneumonia, skin and skin structure infections, and vancomycin-resistant Enterococcus faecium infections. Examples of susceptible bacteria include Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, and Streptococcus agalactiae. Linezolid is not indicated for the treatment of Gram-negative infections, nor has it been evaluated for use longer than 28 days.
Associated Conditions
- Community Acquired Pneumonia (CAP) caused by Staphylococcus Aureus Infections
- Community acquired pneumonia caused by Susceptible strains of Streptococcus pneumoniae
- Complicated Skin and Skin Structure Infection caused by Staphylococcus Aureus Infections
- Complicated Skin and Skin Structure Infection caused by Streptococcus Agalactiae Infection
- Complicated Skin and Skin Structure Infection caused by Streptococcus Pyogenes Infection
- Nosocomial Pneumonia caused by Staphylococcus Aureus Infections
- Nosocomial Pneumonia caused by Streptococcus Pneumoniae Infections
- Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus Aureus Infections
- Uncomplicated Skin and Skin Structure Infections caused by Streptococcus Pyogenes Infection
- Vancomycin-resistant Enterococcus faecium infection
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/11/20 | N/A | Completed | Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva | ||
2015/10/28 | Phase 2 | Completed | Medecins Sans Frontieres, Netherlands | ||
2015/10/07 | Phase 3 | Completed | |||
2015/09/24 | Phase 3 | Completed | |||
2015/07/09 | Phase 3 | Completed | |||
2015/05/27 | Phase 2 | Completed | |||
2015/04/27 | Phase 2 | Completed | |||
2015/03/04 | Phase 3 | Completed | |||
2015/01/07 | Phase 3 | Completed | |||
2014/10/31 | Phase 2 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||