LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Peak

linezolid

NDAINTRAVENOUSSOLUTION

Approved

Jun 2015

Lifecycle

Peak

Competitive Pressure

30/100

Clinical Trials

20

Mechanism of Action

12.1 Mechanism of Action Linezolid is an antibacterial drug [ see ]. 12.2 Pharmacodynamics In a randomized, positive- and placebo-controlled crossover thorough QT study, 40 healthy subjects were administered a single linezolid 600 mg dose via a 1 hour IV infusion, a single linezolid 1,200 mg dose…

Pharmacologic Class:

Oxazolidinone Antibacterial

Indications (17)

Gram-negative infections nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible -resistant isolates)Streptococcus pneumoniae [ see ]community-acquired pneumonia caused by Streptococcus pneumoniae including cases with concurrent bacteremia Staphylococcus aureus (methicillin-susceptible isolates only) [ see ]complicated skin skin structure infections including diabetic foot infections without concomitant osteomyelitis caused by Staphylococcus aureus (methicillin-susceptible Streptococcus pyogenes Streptococcus agalactiae vancomycin-resistant Enterococcus faecium infections including cases with concurrent bacteremia [ see ]children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ()

Clinical Trials (5)

NCT06058299Phase 2Active Not Recruiting

Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis

Started Oct 2023

309 enrolled

Pulmonary TBPulmonary TuberculosisDrug Sensitive Tuberculosis

NCT03828201Phase 2Recruiting

Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB

Started Jun 2022

220 enrolled

Tuberculosis, Multidrug-Resistant

NCT03537495Phase 2Completed

Pharmacokinetic Study of Linezolid for TB Meningitis

Started Jun 2021

36 enrolled

Tuberculosis, MeningealLinezolid

NCT03086486Phase 3Completed

Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis

Started Nov 2017

181 enrolled

Tuberculosis, PulmonaryTuberculosis, Multidrug-ResistantTuberculosis, MDR+4 more

NCT02877927Phase 3Completed

Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

Started Aug 2016

735 enrolled

Bacterial InfectionsSkin Structures and Soft Tissue Infections

Company

External Resources

Full prescribing information

FDA approval history

Drug nomenclature & identifiers