TheraRadar
Data updated: May 26, 2026

LINEZOLID

Infectious Disease Approved 2012-06-27

LINEZOLID is indicated for the treatment of Nosocomial Pneumonia; Community-Acquired Pneumonia; Complicated Skin and Skin Structure Infections; Diabetic Foot Infection; Vancomycin-Resistant Enterococcus faecium Infections; Bacteremia.

Source: FDA Label • RISING • Oxazolidinone Antibacterial
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How LINEZOLID Works

Linezolid is a protein synthesis inhibitor. It exerts its antibacterial effect by binding to the 23S ribosomal RNA of the 50S subunit, which prevents the formation of the functional 70S initiation complex. This unique mechanism of action prevents the translation process in susceptible Gram-positive bacteria and helps minimize cross-resistance with other classes of antibiotics that target protein synthesis.

Source: FDA Label
20
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2012-06-27
Routes
ORAL, INTRAVENOUS
Dosage Forms
TABLET, SOLUTION, FOR SUSPENSION

Companies

RISING GLENMARK SPECLT PHARMOBEDIENT Pfizer Hikma HETERO LABS LTD V SAGENT PHARMS INC ALEMBIC EUGIA PHARMA ZYDUS PHARMS CHARTWELL RX Teva Novartis NANG KUANG PHARM CO ALKEM LABS LTD HQ SPCLT PHARMA NOVEL LABS INC GATE PHARMS MACLEODS PHARMS LTD AMNEAL PHARMS Fresenius Kabi HETERO LABS CAPLIN
Active Ingredient: LINEZOLID

LINEZOLID Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
173 FDA actions from 2012 to 2025
Dec 2025 ORIGINAL
Update
Jul 2025 SUPPL
Label · Labeling
May 2025 SUPPL
Label · Labeling

What LINEZOLID Treats

6 indications

LINEZOLID is approved for 6 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Nosocomial Pneumonia
  • Community-Acquired Pneumonia
  • Complicated Skin and Skin Structure Infections
  • Diabetic Foot Infection
  • Vancomycin-Resistant Enterococcus faecium Infections
  • Bacteremia
Source: FDA Label

LINEZOLID Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

DALBAVANCIN HYDROCHLORIDE
Fresenius Kabi
2025 1 indic.
PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
B BRAUN
2025 7 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to LINEZOLID

3 of 16

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
LINEZOLID
6 shared
Pfizer
Shared indications:
Nosocomial PneumoniaCommunity-Acquired PneumoniaComplicated Skin and Skin Structure Infections +3 more
ZYVOX
LINEZOLID
3 shared
Pfizer
Shared indications:
Nosocomial PneumoniaCommunity-Acquired PneumoniaComplicated Skin and Skin Structure Infections
PIPERACILLIN
PIPERACILLIN SODIUM
2 shared
ISTITUTO BIO ITA SPA
Shared indications:
Nosocomial PneumoniaCommunity-Acquired Pneumonia
View all 16 similar drugs Pro
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Clinical Trial Registry

65 trials
Trial Sponsor ID Phase Status Title
NCT04310930 FORMaT U1111-1209-0672 Ph 2, Ph 3 recruiting Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
NCT06192160 RAD-TB A5409 DOH-27-032024-5399 Ph 2 recruiting Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
NCT03828201 DRAMATIC H39017 U01AI152980 Ph 2 active not recruiting Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB
NCT04983901 results posted 2020-0074 NCI-2021-01957, 2020-0074 Ph 2 completed PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
NCT07485010 FORMaT-EVOLVE FORMaT002 Ph 2 not yet recruiting Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial
NCT07372781 GCP-TB-2024-11-15 Ph 2 enrolling by invitation Clinical Study on the Early Bactericidal Activity of Contezolid Against Mycobacterium Abscessus Disease
NCT06441006 PRISM-TB 7200AA22CA00005 7200AA22CA00005 Ph 2, Ph 3 recruiting Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
NCT03012360 TAVeM2 2015_66 2016-000735-41 Ph 4 terminated Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis
NCT02333799 results posted Nix-TB-(B-L-Pa) Ph 3 completed A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB
NCT06649721 INSPIRE-BDLL INSPIRE-BDLL Ph 3 active not recruiting Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort
NCT00664313 LiMiT CDC-NCHHSTP-5356 Ph 1, Ph 2 completed TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
NCT06081361 INSPIRE-CODA BJCH-202301 Ph 3 active not recruiting Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort
NCT06058299 NC-009 Ph 2 active not recruiting Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis
NCT02754765 endTB MSF ERB-1555 Ph 3 completed Evaluating Newly Approved Drugs for Multidrug-resistant TB
NCT03583333 results posted 7655A-016 MK-7655A-016, PHRR190814-002177 Ph 3 completed Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)
NCT06709196 REINFORCE 2024-514312-27-00 2024-514312-27-00 Ph 4 recruiting Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
NCT02619994 MDR-END results posted MDR-END Ph 2 completed Treatment Shortening of MDR-TB Using Existing and New Drugs
NCT02269319 ABSSSI results posted MRX-I-03 Ph 2 completed MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
NCT06444802 LINEMAP TTU 08.922 Ph 3 not yet recruiting Model-informed Precision Dosing for Linezolid
NCT02589782 TB-PRACTECAL 1541 Ph 2, Ph 3 completed Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
NCT04207112 PRACTECAL-EE PRACTECAL-EE Ph 2, Ph 3 completed Economic Evaluation of New MDR TB Regimens
NCT03537495 SIMPLE TB-201805.01 Ph 2 completed Pharmacokinetic Study of Linezolid for TB Meningitis
NCT03474198 TRUNCATE-TB TRUNCATE-TB Ph 2, Ph 3 completed Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis
NCT03086486 ZeNix results posted ZeNix (B-Pa-L) NC-007 Ph 3 completed Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
NCT01734694 STOP-NT results posted 7089 Ph 4 terminated Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients
NCT04042077 DRESS results posted DELA-01 2018-001082-17 Ph 3 terminated Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
NCT01805284 UGENT_LIMOP 2012/788 2012-005127-33 Ph 4 completed Pharmacokinetic and Pharmacodynamic Evaluation of Linezolid Administered Intravenously in MRSA-positive, Morbidly Obese Patients With Pneumonia
NCT02454205 NEXT NExT-5001 Ph 2, Ph 3 completed An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis
NCT03927313 LASER-TBM LASER-TBM Ph 2 completed Linezolid, Aspirin and Enhanced Dose Rifampicin in HIV-TBM
NCT00865280 CSSI results posted PTK 0796 CSSI-0804 Ph 3 terminated Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
NCT03032380 APEKS-NP results posted 1615R2132 2016-003020-23 Ph 3 completed Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens
NCT01792804 SABATO Uni-Koeln-1400 2013-000577-77 Ph 3 completed Staphylococcus Aureus Bacteremia Antibiotic Treatment Options
NCT02493764 RESTORE-IMI 2 results posted 7655A-014 2015-000246-34, 163240 Ph 3 completed Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)
NCT00625703 results posted IRB File # 112007-010 Ph 2 completed Pharmacokinetics of Linezolid in Children With Cystic Fibrosis
NCT02679573 DEFINE-CABP results posted ML-3341-306 2015-003026-14 Ph 3 completed Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia
NCT02426918 results posted Debio 1450-ABSSSI-201 218187 Ph 2 completed Study of Debio 1450 for Bacterial Skin Infections
NCT02559310 LEAP results posted NAB-BC-3781-3101 Ph 3 completed Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia
NCT01283581 results posted RX-3341-202 Ph 2 completed A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
NCT02019420 results posted 1986-002 TR701-132, 2013-004154-22 Ph 3 completed Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)
NCT00948142 CE06-300 Ph 2 completed Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
NCT02570490 CE06-301 Ph 3 completed Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT02378480 results posted PTK0796-ABSI-1108 Ph 3 completed Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
NCT02279875 LIN-CL001 Ph 2 completed A Phase 2 Trial to Evaluate the Efficacy and Safety of Linezolid in Tuberculosis Patients. (LIN-CL001)
NCT02877927 results posted PTK0796-ABSI-16301 Ph 3 completed Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
NCT01967225 results posted 16099 Ph 3 completed Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections
NCT01421511 results posted 1986-010 TR701-113 Ph 3 completed TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT01170221 ABSSSI results posted 1986-009 TR701-112 Ph 3 completed TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
NCT01209078 results posted 113414 Ph 2 completed GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection
NCT02975570 DAZZLE H-36160 Ph 3 withdrawn Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin
NCT00671814 SAD/MAD 1986-016 TR701-101 Ph 1 completed Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults

Showing 50 of 65 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LINEZOLID FDA Label Details

Indications & Usage

LINEZOLID is indicated for the treatment of Nosocomial Pneumonia; Community-Acquired Pneumonia; Complicated Skin and Skin Structure Infections; Diabetic Foot Infection; Vancomycin-Resistant Enterococcus faecium Infections; Bacteremia.

Looking for the branded version?

ZYVOX

Full clinical data, patents, trials, and competitive landscape for linezolid.

See ZYVOX

Data Sources

FDA Approval: ANDA078845 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.