Clinical Trials

Linezolid is documented in numerous clinical trials and non-interventional studies spanning Phase 1 through Phase 4, evaluating its efficacy in conditions such as multidrug- and extensively drug-resistant tuberculosis, Staphylococcus aureus infections, community-acquired pneumonia, and catheter-related bacteremia. Sponsored by academic medical centers, university hospital networks, government research institutes, and biopharmaceutical companies, these trials encompass recruitment statuses ranging from active and recruiting to completed or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06441006 RECRUITING
Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Tuberculosis, MDR
University of California, San Francisco
 2025-10-03 PHASE2; PHASE3
NCT07485010 NOT_YET_RECRUITING
Mycobacterium Abscessus Pulmonary Disease; Mycobacterium Abscessus Infection; Non-Tuberculous Mycobacterial (NTM) Infections; Non-Tuberculous Mycobacteria Pulmonary Disease
The University of Queensland
 2027-04 PHASE2
NCT07076225 NOT_YET_RECRUITING
Pulmonary Tuberculosis
Shenzhen Third People's Hospital
 2025-07-25 PHASE3
NCT04310930 RECRUITING
Pulmonary Disease Due to Mycobacteria (Diagnosis)
The University of Queensland
 2020-03-02 PHASE2; PHASE3
NCT06590428 RECRUITING
Rifampin-resistant Tuberculosis; Drug-resistant Tuberculosis
Albert Einstein College of Medicine
 2026-04-07
NCT06905522 RECRUITING
Pulmonary Tuberculosis
Shenzhen Third People's Hospital
 2025-06-18 PHASE3
NCT05571722 RECRUITING
Antibiotic Prophylaxis; General Surgery
Assistance Publique Hopitaux De Marseille
 2024-11-12 PHASE4
NCT06958835 RECRUITING
Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)
University Hospital, Basel, Switzerland
 2025-10-06
NCT05383742 RECRUITING
Tuberculous Meningitis
National Institute of Allergy and Infectious Diseases (NIAID)
 2023-12-07 PHASE2
NCT07773610 NOT_YET_RECRUITING
Tuberculosis, Pulmonary
TASK Applied Science
 2026-07-23 PHASE2
NCT07228702 ENROLLING_BY_INVITATION
Non-Tuberculous Mycobacterial (NTM) Pneumonia; Mycobacterium Abscessus Infection
Vancouver Coastal Health
 2026-01-11 PHASE1
NCT07477119 RECRUITING
Linezolid; Tuberculosis Multi Drug Resistant Active; Therapeutic Drug Monitoring (TDM)
Marco Schiuma
 2026-04 PHASE4
NCT07126639 NOT_YET_RECRUITING
Efficacy and Safety
Wuhan Pulmonary Hospital
 2025-09-01
NCT07198685 NOT_YET_RECRUITING
Treat to Target; Treatment Duration
Wuhan Pulmonary Hospital
 2025-09-30
NCT07517445 SUSPENDED
Drug Susceptible Pulmonary Tuberculosis
Gates Medical Research Institute
 2026-04-17 PHASE2
NCT07672405 RECRUITING
Tuberculosis, Pulmonary
Global Alliance for TB Drug Development
 2026-07-09 PHASE2
NCT03828201 ACTIVE_NOT_RECRUITING
Tuberculosis, Multidrug-Resistant
Boston University
 2022-06-07 PHASE2
NCT06921213 RECRUITING
Syphilis, Congenital
London School of Hygiene and Tropical Medicine
 2026-05-04 PHASE2
NCT06649721 ACTIVE_NOT_RECRUITING
Drug-resistant Tuberculosis; Pulmonary Tuberculosis; Rifampin-resistant Tuberculosis
Huashan Hospital
 2024-11-27 PHASE3
NCT06114628 RECRUITING
Pulmonary Tuberculosis
University College, London
 2024-01-09 PHASE2
NCT06709196 RECRUITING
Cystectomy; Bladder Cancer Requiring Cystectomy; Postoperative Infections; Antibiotic Prophylaxis; Ileal Conduit
Rigshospitalet, Denmark
 2025-01-07 PHASE4
NCT07372781 ENROLLING_BY_INVITATION
Monotherapy; Mycobacterium Abscessus Infection
Beijing Chest Hospital
 2026-01-01 PHASE2
NCT05398679 RECRUITING
Endocarditis Infective
Fundacion Clinic per a la Recerca Biomédica
 2022-08-17 PHASE4
NCT06192160 RECRUITING
Pulmonary Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2025-03-11 PHASE2
NCT07525427 RECRUITING
Drug Susceptible Pulmonary Tuberculosis
Gates Medical Research Institute
 2026-04-14 PHASE2
NCT06081361 ACTIVE_NOT_RECRUITING
Pulmonary Tuberculosis; Rifampicin-resistant Tuberculosis
Beijing Chest Hospital
 2023-12-22 PHASE3
NCT05548426 ACTIVE_NOT_RECRUITING
Syphilis
University of Southern California
 2023-09-28 PHASE2
NCT05369052 RECRUITING
Diabetic Foot Infection
MicuRx
 2022-05-03 PHASE3
NCT07301294 NOT_YET_RECRUITING
Double J Stent
Menoufia University
 2026-01-01 PHASE4
NCT05069974 COMPLETED
Early Latent Syphilis; Primary Syphilis; Secondary Syphilis
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2021-10-14 PHASE3
NCT05534750 RECRUITING
Tuberculosis; Multidrug Resistant Tuberculosis
Assistance Publique - Hôpitaux de Paris
 2023-04-20 PHASE2
NCT06444802 UNKNOWN
Gram-Positive Bacterial Infections
University of Hamburg-Eppendorf
 2024-09-01 PHASE3
NCT06811012 ENROLLING_BY_INVITATION
Tuberculosis; Bone; Joint
Beijing Chest Hospital
 2024-01-31 PHASE1; PHASE2
NCT06811025 ENROLLING_BY_INVITATION
Tuberculosis; Meningitis
Beijing Chest Hospital
 2024-02-01 PHASE1; PHASE2
NCT07138521 NOT_YET_RECRUITING
Kidney Disease
Alexandria University
 2025-10-15 PHASE4
NCT05306223 UNKNOWN
Tuberculosis, Multidrug-Resistant
Beijing Chest Hospital
 2022-05-10 PHASE4
NCT05944458 COMPLETED
Linezolid; Antioxidant; Thrombocytopenia; Critical Illness; ICU
Helwan University
 2023-08-01 PHASE4
NCT06476210 UNKNOWN
Pulmonary Tuberculosis
Beijing Chest Hospital
 2024-06 PHASE4
NCT05382312 COMPLETED
Tuberculosis
GlaxoSmithKline
 2022-07-26 PHASE2
NCT06336824 UNKNOWN
Staphylococcus Aureus Bacteremia
Clinical Research Centre, Malaysia
 2024-06-28 PHASE3
NCT05007821 COMPLETED
Tuberculosis, Multidrug-Resistant; Tuberculosis; Tuberculosis, Pulmonary
National Institute of Allergy and Infectious Diseases (NIAID)
 2022-09-27 PHASE2
NCT05977868 TERMINATED
Endovascular Infection; Bone and Joint Infection; Skin and Soft Tissue Infection; Pulmonary Infection; Gastrointestinal Infection; Genitourinary Infection
West Virginia University
 2023-08-04 PHASE4
NCT05040126 UNKNOWN
Pre-Extensively Drug-Resistant Pulmonary TB; Treatment Intolerant Multidrug-Resistant Pulmonary TB; Non-responsive Multidrug-Resistant Pulmonary TB
Tuberculosis Research Centre, India
 2021-10-07 PHASE3
NCT06058299 ACTIVE_NOT_RECRUITING
Pulmonary TB; Pulmonary Tuberculosis; Drug Sensitive Tuberculosis
Global Alliance for TB Drug Development
 2023-10-31 PHASE2
NCT05156437 TERMINATED
Endocarditis
West Virginia University
 2022-03-16 PHASE4
NCT03896685 COMPLETED
Tuberculosis, Multidrug-Resistant; Tuberculosis; Pulmonary Tuberculoses; Mycobacterial Infections; Bacterial Infections; Gram-Positive Bacterial Infections
Médecins Sans Frontières, France
 2020-04-06 PHASE3
NCT03012360 TERMINATED
Mechanical Ventilation Complication; Critical Illness
University Hospital, Lille
 2018-02-08 PHASE4
NCT05801484 UNKNOWN
Side-effect of Antibiotic; Efficacy; Pharmacokinetics; Critical Illness; Intensive Care Unit ICU
Cluj Municipal Clinical Hospital
 2022-07-01
NCT04717908 COMPLETED
Multidrug Resistant Tuberculosis
Huashan Hospital
 2021-01-20
NCT05764876 COMPLETED
Yaws; Cutaneous Ulcer
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2023-03-14 PHASE3
NCT04062201 COMPLETED
Tuberculosis; Pre-XDR-TB; Extensively Drug-Resistant Tuberculosis; Multi Drug Resistant Tuberculosis; Rifampicin Resistant Tuberculosis
Wits Health Consortium (Pty) Ltd
 2019-08-22 PHASE3
NCT05813951 UNKNOWN
Treatment Efficacy
Ain Shams University
 2022-12-02
NCT04983901 COMPLETED
Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
M.D. Anderson Cancer Center
 2021-09-14 PHASE2
NCT05339802 UNKNOWN
Skin Infection
Mabwell (Shanghai) Bioscience Co., Ltd.
 2022-02-16 PHASE2
NCT04021121 COMPLETED
Tuberculosis, Meningeal
University of California, San Francisco
 2021-05-05 PHASE2
NCT05944445 Recruiting
Thrombocytopenia; Drugs
Helwan University
 2023-07-13 --
NCT06291181 COMPLETED
Staphylococcus Aureus
Sohag University
 2023-01-01
NCT02754765 COMPLETED
Tuberculosis, Multidrug-Resistant; Infection, Bacterial; Pulmonary Tuberculoses
Médecins Sans Frontières, France
 2016-12 PHASE3
NCT05571722 Not yet recruiting
Antibiotic Prophylaxis|General Surgery
Assistance Publique Hopitaux De Marseille
 2023-04-03 Phase 4
NCT03537495 COMPLETED
Tuberculosis, Meningeal; Linezolid
Universitas Padjadjaran
 2021-06-21 PHASE2
NCT06291181 Completed
Staphylococcus Aureus
Sohag University
 2023-01-01 Not Applicable
NCT04545788 UNKNOWN
Tuberculosis
Beijing Chest Hospital
 2020-08-01
NCT05381194 Recruiting
Multidrug- and Rifampicin-resistant Tuberculosis
Asan Medical Center|Pusan National University Hospital|Samsung Medical Center|Seoul National University Hospital|Severance Hospital|Chonnam National University Hospital|The Catholic University of Korea|Chungbuk National University Hospital|Ulsan University Hospital|Soon Chun Hyang University|Incheon St.Mary''s Hospital|DongGuk University|National Medical Center Seoul
 2022-12-13 Phase 4
NCT04081077 UNKNOWN
Multi-drug Resistant Tuberculosis; Extensively Drug-Resistant Tuberculosis; Pulmonary Tuberculosis
Medecins Sans Frontieres, Netherlands
 2019-08-06 PHASE2; PHASE3
NCT04207112 COMPLETED
Multi-drug Resistant Tuberculosis; Extensively Drug-Resistant Tuberculosis; Pulmonary Tuberculoses
Medecins Sans Frontieres, Netherlands
 2020-10-20 PHASE2; PHASE3
NCT02589782 COMPLETED
Tuberculosis, Multidrug-Resistant; Extensively Drug-Resistant Tuberculosis; Tuberculosis, Pulmonary
Medecins Sans Frontieres, Netherlands
 2017-01 PHASE2; PHASE3
NCT03583333 COMPLETED
Hospital-Acquired Bacterial Pneumonia; Ventilator-Associated Bacterial Pneumonia
Merck Sharp & Dohme LLC
 2018-09-18 PHASE3
NCT05801484 Recruiting
Side-effect of Antibiotic|Efficacy|Pharmacokinetics|Critical Illness|Intensive Care Unit ICU
Cluj Municipal Clinical Hospital|Iuliu Hatieganu University of Medicine and Pharmacy
 2022-07-01 Not Applicable
NCT03474198 COMPLETED
Tuberculosis, Pulmonary
University College, London
 2018-03-21 PHASE2; PHASE3
NCT04531332 UNKNOWN
Pneumonia
October 6 University
 2019-11-15
NCT02975570 WITHDRAWN
Tuberculosis Multi Drug Resistant Active
Boston University
 2017-08 PHASE3
NCT03220074 COMPLETED
Non-tuberculous Mycobacterial Infections
Mahidol University
 2017-12-15 PHASE4
NCT02619994 COMPLETED
Tuberculosis, Multidrug-Resistant
Seoul National University Hospital
 2016-01 PHASE2
NCT03485950 COMPLETED
Other Infectious Diseases
M.D. Anderson Cancer Center
 2018-05-16 PHASE2
NCT03927313 COMPLETED
Tuberculosis Meningitis; HIV-1-infection
University of Cape Town
 2019-06-12 PHASE2
NCT03086486 COMPLETED
Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Tuberculosis, MDR; Tuberculosis; Extensively Drug-Resistant Tuberculosis; Pre-XDR-TB; XDR-TB
Global Alliance for TB Drug Development
 2017-11-21 PHASE3
NCT02454205 COMPLETED
Tuberculosis; Multidrug Resistant Tuberculosis; Extensively-drug Resistant Tuberculosis
University of Cape Town
 2015-11-12 PHASE2; PHASE3
NCT04042077 TERMINATED
Surgical Site Infection
Menarini Group
 2019-09-25 PHASE3
NCT01792804 COMPLETED
Staphylococcus Aureus Infection
Heinrich-Heine University, Duesseldorf
 2013-12 PHASE3
NCT02493764 COMPLETED
Bacterial Pneumonia
Merck Sharp & Dohme LLC
 2015-11-24 PHASE3
NCT03747497 COMPLETED
Skin Diseases, Bacterial; Gram-Positive Bacterial Infections
MicuRx
 2018-11-15 PHASE2
NCT03032380 COMPLETED
Healthcare-associated Pneumonia (HCAP); Hospital Acquired Pneumonia (HAP); Ventilator Associated Pneumonia (VAP)
Shionogi
 2017-10-24 PHASE3
NCT02333799 COMPLETED
Pulmonary Tuberculosis
Global Alliance for TB Drug Development
 2015-03 PHASE3
NCT03405064 COMPLETED
Acute Bacterial Skin and Skin Structure Infections
Wockhardt
 2017-08-25 PHASE3
NCT03841721 UNKNOWN
Healthy
Prince of Songkla University
 2018-05-01 PHASE1
NCT02679573 COMPLETED
Community Acquired Bacterial Pneumonia
Melinta Therapeutics, Inc.
 2016-12-14 PHASE3
NCT02019420 COMPLETED
Pneumonia
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2014-01-06 PHASE3
NCT02778828 COMPLETED
Tuberculosis
Fondation Hôpital Saint-Joseph
 2015-11-04
NCT02877927 COMPLETED
Bacterial Infections; Skin Structures and Soft Tissue Infections
Paratek Pharmaceuticals Inc
 2016-08 PHASE3
NCT02559310 COMPLETED
Community Acquired Pneumonia
Nabriva Therapeutics AG
 2015-09 PHASE3
NCT01619410 TERMINATED
Skin Diseases, Bacterial; Abscess
University of Chicago
 2012-01
NCT02279875 COMPLETED
Pulmonary Tuberculosis
Global Alliance for TB Drug Development
 2014-11 PHASE2
NCT02269644 WITHDRAWN
Community Acquired Pneumonia
Durata Therapeutics Inc., an affiliate of Allergan plc
 2015-11 PHASE3
NCT02570490 COMPLETED
Acute Bacterial Skin and Skin Structure Infections
Arrevus Inc.
 2015-11 PHASE3
NCT01967225 COMPLETED
Skin Diseases, Infectious
Bayer
 2013-11-23 PHASE3
NCT01805284 COMPLETED
Pneumonia
University Ghent
 2013-02 PHASE4
NCT02426918 COMPLETED
Bacterial Infections
Debiopharm International SA
 2015-05 PHASE2
NCT02732327 TERMINATED
Neoplasms; Febrile Neutropenia
Forest Laboratories
 2016-05-17 PHASE2
NCT01757236 UNKNOWN
Hip Prosthetic Joint Infection
University Hospital, Tours
 2012-10 PHASE2
NCT02378480 COMPLETED
Bacterial Infections; Skin Structures and Soft Tissue Infections
Paratek Pharmaceuticals Inc
 2015-06 PHASE3
NCT02066402 COMPLETED
Bacterial Infections
Bayer
 2014-03-04 PHASE3
NCT01994460 UNKNOWN
Pulmonary Tuberculosis Without Resistance to Rifampicin
Seoul National University Hospital
 2014-01 PHASE2
NCT02269319 COMPLETED
Bacterial Infections
MicuRx
 2015-02 PHASE2
NCT01570192 TERMINATED
Bacterial Pneumonia
University of Florida
 2010-09 PHASE2
NCT01592032 UNKNOWN
Catheter-Related Infections; Bacteremia.
Clinica Universidad de Navarra, Universidad de Navarra
 2012-05 PHASE4
NCT01400867 COMPLETED
Infections, Pediatrics
Forest Laboratories
 2011-12 PHASE2; PHASE3
NCT02087566 COMPLETED
Renal Failure; Impaired Renal Function
Damanhour University
 2013-10
NCT00711854 COMPLETED
MRSA Infection
University Hospital, Geneva
 2009-01 PHASE4
NCT00359632 TERMINATED
Optic Nerve Diseases
Pfizer
 2008-11 PHASE3
NCT01356472 UNKNOWN
Methicillin-resistant Staphylococcus Aureus; Pneumonia, Ventilator-Associated
Ruijin Hospital
 2011-06 PHASE4
NCT01421511 COMPLETED
Skin and Subcutaneous Tissue Bacterial Infections
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2011-09-15 PHASE3
NCT00925093 WITHDRAWN
Neurosurgery
Aarhus University Hospital
 2011-09 PHASE1
NCT01554995 COMPLETED
Healthy
LigaChem Biosciences, Inc.
 2012-03 PHASE1
NCT01431339 COMPLETED
Abscess; Wound Infection; Surgical Site Infection; Cellulitis
Durata Therapeutics Inc., an affiliate of Allergan plc
 2011-07 PHASE3
NCT01521364 COMPLETED
Multidrug-resistant Tuberculosis; Extensively Drug-resistant Tuberculosis
University Medical Center Groningen
 2011-12 PHASE4
NCT00727844 COMPLETED
Pulmonary Tuberculosis; Multidrug Resistant Tuberculosis; Extensively Drug Resistant Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2008-07 PHASE2
NCT01339091 COMPLETED
Abscess; Wound Infection; Surgical Site Infection; Cellulitis
Durata Therapeutics Inc., an affiliate of Allergan plc
 2011-03 PHASE3
NCT01734694 TERMINATED
Health Care Associated Pneumonia; Osteomyelitis/Septic Arthritis; Endocarditis; Bacteremia; Acute Bacterial Skin and Skin Structure Infections
Henry Ford Health System
 2011-10 PHASE4
NCT01544673 COMPLETED
Gram Positive Infection
Pfizer
 2012-03 PHASE1
NCT01283581 COMPLETED
Skin and Subcutaneous Tissue Bacterial Infections
Melinta Therapeutics, Inc.
 2011-01 PHASE2
NCT01170221 COMPLETED
Skin and Subcutaneous Tissue Bacterial Infections
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2010-08-15 PHASE3
NCT00625703 COMPLETED
Cystic Fibrosis
University of Texas Southwestern Medical Center
 2010-12 PHASE2
NCT01209078 COMPLETED
Skin Infections, Bacterial
GlaxoSmithKline
 2010-08-17 PHASE2
NCT01128530 COMPLETED
Complicated Skin and Skin Structure Infections
Furiex Pharmaceuticals, Inc
 2010-06 PHASE2
NCT00664313 COMPLETED
Multi-drug Resistant Tuberculosis; Extensively Drug Resistant Tuberculosis
Centers for Disease Control and Prevention
 2009-04 PHASE1; PHASE2
NCT01200654 COMPLETED
Methicillin-Resistant Staphylococcus AureuS
University Hospital, Toulouse
 2007-11 PHASE4
NCT01039610 WITHDRAWN
Infections, Bacterial
GlaxoSmithKline
 2009-11 PHASE1
NCT00852540 COMPLETED
Skin Infections, Bacterial
Stiefel, a GSK Company
 2009-04 PHASE3
NCT00876850 WITHDRAWN
Skin Structures and Soft Tissue Infections
Paratek Pharmaceuticals Inc
 2009-07 PHASE3
NCT00990990 COMPLETED
Tuberculosis
Sequella, Inc.
 2009-10 PHASE1
NCT00865280 TERMINATED
Skin Diseases, Infectious
Paratek Pharmaceuticals Inc
 2009-04-04 PHASE3
NCT01055769 COMPLETED
Healthy Volunteers
Pfizer
 2010-03 PHASE1
NCT00948142 COMPLETED
Skin Diseases, Bacterial
Arrevus Inc.
 2009-08 PHASE2
NCT00084266 COMPLETED
Methicillin Resistant Staphylococcus Aureus (MRSA)
Pfizer
 2004-10 PHASE4
NCT00949130 COMPLETED
Acute Bacterial Skin and Skin Structure Infections
Novexel Inc
 2009-11 PHASE2
NCT00795145 COMPLETED
Bacterial Infections
Pfizer
 2008-12 PHASE1
NCT00633152 COMPLETED
Bacterial Infection
Forest Laboratories
 2008-02 PHASE2
NCT00671814 COMPLETED
Healthy Subjects
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2008-01-06 PHASE1
NCT00646958 COMPLETED
Infectious Skin Diseases; Bacterial Skin Diseases; Staphylococcal Skin Infections; Streptococcal Infections; Abscess
Melinta Therapeutics, Inc.
 2007-12 PHASE2
NCT03716024 COMPLETED
Infectious Skin Disease; Bacterial Skin Disease
Paratek Pharmaceuticals Inc
 2007-07-18 PHASE2
NCT00396084 COMPLETED
Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2004-02-10 PHASE1; PHASE2
NCT00326287 COMPLETED
Pneumonia
Basilea Pharmaceutica
 2006-06 PHASE3
NCT00087490 COMPLETED
Skin/Soft Tissue Infections; Methicillin Resistant Staphylococcus Aureus (MRSA)
Pfizer
 2004-10 PHASE4
NCT00501150 COMPLETED
Gram-positive Bacterial Infections; Staphylococcal Infections
Imperial College London
 2005-09
NCT00210964 COMPLETED
Pneumonia
Basilea Pharmaceutica
 2005-04 PHASE3
NCT00229008 COMPLETED
Pneumonia
Basilea Pharmaceutica
 2005-11 PHASE3
NCT00108433 TERMINATED
Bacteremia; Gram-Positive Bacterial Infections
Pfizer
 2005-09 PHASE3
NCT00035854 COMPLETED
Bacterial Infections
Pfizer
 2002-02 PHASE3
NCT00035425 COMPLETED
Febrile Neutropenia
Pfizer
 2001-11 PHASE3
NCT00035269 COMPLETED
Pneumonia, Pneumococcal; Community Acquired Infections; Gram-positive Bacterial Infections
Pfizer
 2001-12 PHASE3
NCT00255996 COMPLETED
Burns
Pfizer
 2006-05 PHASE1
NCT00572559 COMPLETED
Pneumonia, Ventilator-Associated
Pfizer
 2002-11 PHASE4
NCT00037050 COMPLETED
Bacterial Infections; Gram-Positive Bacterial Infections; Bacteremia
Pfizer
 2002-04 PHASE3
NCT00150332 COMPLETED
Infections, Nosocomial
Pfizer
 2003-01 PHASE3
NCT00299520 COMPLETED
Complicated Skin and Skin Structure Infection
Arpida AG
 2005-06 PHASE3
NCT00147511 COMPLETED
Gram-Positive Bacterial Infections; Skin and Connective Tissue Diseases
Pfizer
 2003-06 PHASE4
NCT00303550 COMPLETED
Skin Diseases, Bacterial
Arpida AG
 2006-03 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-09-02)

Check the Linezolid (PNU-100766) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Linezolid selectively binds to the 23S ribosomal RNA of the bacterial 50S subunit, preventing the assembly of the functional 70S initiation complex and blocking early bacterial protein translation. This inhibition of protein synthesis halts bacterial replication and growth, providing the mechanistic basis for its therapeutic activity against severe resistant pathogens such as multidrug-resistant tuberculosis and methicillin-resistant Staphylococcus aureus studied in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.