LINEZOLID

Post-LOE

linezolid

Fresenius Kabi

ANDAINTRAVENOUSSOLUTION

Approved

Mar 2016

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

LINEZOLID (linezolid) by Fresenius Kabi is [ see clinical pharmacology ( ) ]. Approved for gram-negative infections, children for the treatment of the following infections caused by susceptible gram-positive bacteria: nosocomial pneumonia ( ). First approved in 2016.

Drug data last refreshed 18h ago

Mechanism of Action

[ see Clinical Pharmacology ( ) ].

Pharmacologic Class:

Oxazolidinone Antibacterial

Indications (2)

Gram-negative infections children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ( )

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (20)

NCT07517445Phase 2Recruiting

Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis

Started Apr 2026

165 enrolled

Drug Susceptible Pulmonary Tuberculosis

NCT06590428N/ARecruiting

Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis

Started Mar 2026

280 enrolled

Rifampin-resistant TuberculosisDrug-resistant Tuberculosis

NCT06444802Phase 3Not Yet Recruiting

Model-informed Precision Dosing for Linezolid

Started Sep 2024

28 enrolled

Gram-Positive Bacterial Infections

NCT05383742Phase 2Recruiting

Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis

Started Dec 2023

330 enrolled

Tuberculous Meningitis

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