Zyvox

(Linezolid)

ApprovedSmall molecule

Linezolid is an antibiotic used to treat serious bacterial infections, particularly those caused by resistant bacteria like MRSA. It works by stopping bacteria from growing and is often used when other antibiotics don't work.[2] Zyvox is currently approved and in use across 33 indications[4].[1]

Zyvox is one of 410 small molecule programs targeting Linezolid. It is currently in Approved.

Indications

130

Total Trials

Active Trials

409

Competitors

108

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

LinezolidNot yet recruiting

BacteriemiaActive, not recruiting

SepsisActive, not recruiting

Bacterial DiseaseActive, not recruiting

Infective EndocarditisActive, not recruiting

Foster-Kennedy SyndromeApproved

Pneumococcal PneumoniaApproved

Gram-Positive Bacterial InfectionsNot yet recruiting

Skin DiseaseApproved

Staphylococcal Skin InfectionsActive, not recruiting

LinezolidApproved

Not yet recruiting

BacteriemiaApproved

Active, not recruiting

SepsisPreclinical

Active, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

Infective EndocarditisApproved

Active, not recruiting

Foster-Kennedy SyndromeApproved

Approved

Pneumococcal PneumoniaApproved

Approved

Gram-Positive Bacterial InfectionsApproved

Not yet recruiting

Skin DiseaseApproved

Approved

Staphylococcal Skin InfectionsPreclinical

Active, not recruiting

Showing 10 of 33 indications

Competition

Competitive Landscape

155 competitors in Pneumonia

#DrugCompanyPhaseTrials

Zyvox

Pfizer

Approved

7 2

Jakafi

Incyte

Preclinical

1 3

Primaquine

Sanofi

Preclinical

1 4

Acanya

Pfizer

Preclinical

1 5

Prevacid

Takeda

Preclinical

1 6

Plaquenil

Jazz Pharmaceuticals

Preclinical

1 7

Innohep

Jazz Pharmaceuticals

Preclinical

1 8

Avlosulfon

AAlmirall, S.A.

Preclinical

4 9

Primsol

CConrado Roberto Hoffmann Filho

Preclinical

2 10

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Tuberculosis

NCT06081361

Q1 2027

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT06709196

Phase 2Active, not recruiting

Pulmonary TB

NCT06058299

Q2 2027

Phase 2Active, not recruiting

Tuberculosis, Multidrug-Resistant

NCT03828201

Phase 3Active, not recruiting

Tuberculosis

NCT06649721

Phase 2Recruiting

Syphilis, Congenital

NCT06921213

Clinical

Trials by Indication[1]

Tuberculosis10 trials

Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis

Unknown status·SSeoul National University Hospital·Phase 2·NCT01994460·429 enrolled

Pharmacokinetic and Therapeutic Adaptation of Linezolid in the Treatment of Multi-Resistant Tuberculosis

Completed·FFondation Hôpital Saint-Joseph·N/A·NCT02778828·31 enrolled

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

Completed·GGlobal Alliance for TB Drug Development·Phase 3·NCT03086486·181 enrolled

Show 7 more trials

Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis

Completed·UUniversity College, London·Phase 2/3·NCT03474198·675 enrolled

A Phase 2 Trial to Evaluate the Efficacy and Safety of Linezolid in Tuberculosis Patients. (LIN-CL001)

Completed·GGlobal Alliance for TB Drug Development·Phase 2·NCT02279875·113 enrolled

An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis

Completed·UUniversity of Cape Town·Phase 2/3·NCT02454205·154 enrolled

Phase II Clinical Study of Contezolid for the Treatment of Bone and Joint Tuberculosis

Enrolling by invitation·—·Phase 1/2·NCT06811012·24 enrolled

Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care

Completed·WWits Health Consortium (Pty) Ltd·Phase 3·NCT04062201·402 enrolled

Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort

Active, not recruiting·—·Phase 3·NCT06081361·186 enrolled

Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort

Active, not recruiting·HHuashan Hospital·Phase 3·NCT06649721·120 enrolled

Treatment8 trials

Treatment Shortening of MDR-TB Using Existing and New Drugs

Completed·SSeoul National University Hospital·Phase 2·NCT02619994·214 enrolled

MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

Completed·MMicuRx·Phase 2·NCT02269319·120 enrolled

Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection

Completed· Pfizer logo

Pfizer·Phase 3·NCT00035425·120 enrolled

Show 5 more trials

Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS

Completed·HHuashan Hospital·N/A·NCT04717908·89 enrolled

Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

Completed·MMicuRx·Phase 2·NCT03747497·196 enrolled

GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection

Completed· GSK logo

GSK·Phase 2·NCT01209078·84 enrolled

Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

Completed·PParatek Pharmaceuticals Inc·Phase 3·NCT02378480·655 enrolled

Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

Completed·PParatek Pharmaceuticals Inc·Phase 3·NCT02877927·735 enrolled

Pneumonia7 trials

Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02019420·726 enrolled

Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

Completed·NNabriva Therapeutics AG·Phase 3·NCT02559310·551 enrolled

Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens

Completed· Shionogi logo

Shionogi·Phase 3·NCT03032380·300 enrolled

Show 4 more trials

Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

Completed· Pfizer logo

Pfizer·Phase 4·NCT00084266·1,225 enrolled

Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia

Completed· Pfizer logo

Pfizer··NCT01819935·5,271 enrolled

Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin

Completed· Pfizer logo

Pfizer··NCT01561469·188 enrolled

Pharmacokinetic and Pharmacodynamic Evaluation of Linezolid Administered Intravenously in MRSA-positive, Morbidly Obese Patients With Pneumonia

Completed·UUniversity Ghent·Phase 4·NCT01805284·15 enrolled

Infections5 trials

Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Completed·NNovexel Inc·Phase 2·NCT00949130·180 enrolled

Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria

Completed· Pfizer logo

Pfizer·Phase 3·NCT00037050·739 enrolled

TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01421511·666 enrolled

Show 2 more trials

Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Completed·AArrevus Inc.·Phase 3·NCT02570490·716 enrolled

TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01170221·667 enrolled

Skin Infection5 trials

Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections

Completed·AArrevus Inc.·Phase 2·NCT00948142·198 enrolled

Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections

Terminated·UUniversity of Chicago·N/A·NCT01619410·25 enrolled

Study of Debio 1450 for Bacterial Skin Infections

Completed·DDebiopharm International SA·Phase 2·NCT02426918·330 enrolled

Show 2 more trials

A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections

Completed·MMelinta Therapeutics, Inc.·Phase 2·NCT01283581·256 enrolled

Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

Completed·MMelinta Therapeutics, Inc.·Phase 2·NCT00646958·150 enrolled

64 more indications

Meningitis4 trials

Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis

Unknown status·HHuashan Hospital··NCT03898635·150 enrolled

Pharmacokinetic Study of Linezolid for TB Meningitis

Completed·UUniversitas Padjadjaran·Phase 2·NCT03537495·36 enrolled

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

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05383742·330 enrolled

Show 1 more trial

Phase II Clinical Study of Contezolid for the Treatment of Tuberculous Meningitis

Enrolling by invitation·—·Phase 1/2·NCT06811025·24 enrolled

Efficacy and Safety4 trials

Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

Completed·PParatek Pharmaceuticals Inc·Phase 2·NCT03716024·234 enrolled

Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Completed· Bayer logo

Bayer·Phase 3·NCT02066402·598 enrolled

Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections

Completed·FForest Laboratories·Phase 2·NCT00633152·150 enrolled

Show 1 more trial

Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)

Completed·FFuriex Pharmaceuticals, Inc·Phase 2·NCT01128530·161 enrolled

Bacterial Pneumonia4 trials

A P3 Comparator Trial in Community Acquired Bacterial Pneumonia

Withdrawn· AbbVie logo

AbbVie·Phase 3·NCT02269644

Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia

Completed·MMelinta Therapeutics, Inc.·Phase 3·NCT02679573·860 enrolled

Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02493764·537 enrolled

Show 1 more trial

Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03583333·274 enrolled

Safety and Efficacy3 trials

Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

Terminated·PParatek Pharmaceuticals Inc·Phase 3·NCT00865280·143 enrolled

A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB

Completed·GGlobal Alliance for TB Drug Development·Phase 3·NCT02333799·109 enrolled

Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

Withdrawn·PParatek Pharmaceuticals Inc·Phase 3·NCT00876850

Abscess3 trials

Clinical Study on the Early Bactericidal Activity of Contezolid Against Mycobacterium Abscessus Disease

Enrolling by invitation·—·Phase 2·NCT07372781·24 enrolled

Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection

Enrolling by invitation·VVancouver Coastal Health·Phase 1·NCT07228702·1 enrolled

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Recruiting·TThe University of Queensland·Phase 2/3·NCT04310930·300 enrolled

Methicillin-resistant Staphylococcus Aureus3 trials

Randomized Clinical Trial to Compare a Regimen of Trimethoprim-sulfamethoxazole Plus Rifampicin With a Regimen of Linezolid in the Treatment of Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection

Completed·UUniversity Hospital, Geneva·Phase 4·NCT00711854·150 enrolled

Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections

Completed· Bayer logo

Bayer·Phase 3·NCT01967225·125 enrolled

Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

Completed· Pfizer logo

Pfizer·Phase 4·NCT00087490·1,077 enrolled

Drug3 trials

Evaluating Newly Approved Drugs for Multidrug-resistant TB

Completed·MMédecins Sans Frontières, France·Phase 3·NCT02754765·754 enrolled

Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)

Completed· Pfizer logo

Pfizer··NCT00666276·1,004 enrolled

Linezolid Dosing Strategies in Drug-Resistant TB

Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05007821·138 enrolled

Hospitalized Patients2 trials

Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study

Terminated· Bayer logo

Bayer··NCT02991131·108 enrolled

Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

Completed· Pfizer logo

Pfizer··NCT01363271·7,260 enrolled

Pulmonary Tuberculosis2 trials

Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00396084·70 enrolled

A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT06192160·315 enrolled

Efficacy2 trials

Time To Efficacy and Onset Of Action Of Linezolid

Completed· Pfizer logo

Pfizer·Phase 4·NCT00147511·118 enrolled

Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin

Withdrawn·—·Phase 3·NCT02975570

Cystic Fibrosis2 trials

Pharmacokinetics of Linezolid in Children With Cystic Fibrosis

Completed·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT00625703·45 enrolled

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

Not yet recruiting·TThe University of Queensland·Phase 2·NCT07485010·300 enrolled

Intravenous2 trials

Study of Intravenous (I.V.) Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections [cSSSI] (ASSIST-2)

Completed·AArpida AG·Phase 3·NCT00303550

Oral Antibiotic Treatment at Home Instead of Intravenous Treatment in Hospital for Resistant Gram Positive Infections

Completed·IImperial College London·N/A·NCT00501150·211 enrolled

ESS2 trials

Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB

Recruiting·UUniversity College, London·Phase 2·NCT06114628·2,500 enrolled

A Study To Assess The Effect Of Linezolid On QTc Interval

Completed· Pfizer logo

Pfizer·Phase 1·NCT00795145·49 enrolled

Thrombocytopenia2 trials

The Incidence of Linezolid-induced Thrombocytopenia (LIT) in Critically Ill Patients, the Risk Factors for LIT

Unknown status·HHelwan University··NCT05944445·310 enrolled

Compare Linezolid-Induced Thrombocytopenia in Patients With Normal Renal Function Versus Impaired Renal Function

Completed·—··NCT06761131·60 enrolled

Tics2 trials

Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy.

Not yet recruiting·MMenoufia University·Phase 4·NCT07301294·100 enrolled

Population Pharmacokinetics of Linezolid

Completed·UUniversity Hospital, Toulouse·Phase 4·NCT01200654·60 enrolled

Adult2 trials

Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers

Completed·SSequella, Inc.·Phase 1·NCT00990990·59 enrolled

Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00671814·80 enrolled

Multidrug-Resistant Tuberculosis2 trials

A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China

Unknown status·—·Phase 4·NCT05306223·212 enrolled

TBTC Study 30: A Phase I/II Pilot Study for Evaluation of Low Dose, Once Daily, Linezolid Plus Optimized Background Therapy (OBT) Versus Placebo Plus OBT for the Treatment of Multi-drug Resistant Tuberculosis

Completed·CCenters for Disease Control and Prevention·Preclinical·NCT00664313·36 enrolled

Tuberculosis, Pulmonary2 trials

Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis (PRISM-TB)

Recruiting·UUniversity of California, San Francisco·Preclinical·NCT06441006·400 enrolled

A Phase 2b, Randomised, Multi-center, Partially Blinded Trial Assessing the Safety and Efficacy of Regimens Containing Sorfequiline, Pretomanid and Linezolid in Adults With Newly Diagnosed, Drug-sensitive, Smear Positive Pulmonary Tuberculosis

Recruiting·GGlobal Alliance for TB Drug Development·Phase 2·NCT07672405·100 enrolled

Antibiotics1 trial

Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

Withdrawn·—·Phase 1·NCT00925093

Oral1 trial

Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01055769·20 enrolled

Quality of Life1 trial

Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

Completed·MMedecins Sans Frontieres, Netherlands··NCT03942354·137 enrolled

Adult Subject1 trial

A Single Center Four Part Study in Healthy Adult Subjects to Evaluate: the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose and Repeat Escalating Oral Doses of GSK945237; the Effect of Linezolid on Hematology Safety Parameters; and the Effects of GSK945237 and Moxifloxacin on QTc.

Withdrawn· GSK logo

GSK·Phase 1·NCT01039610

Function1 trial

Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Males

Completed· Pfizer logo

Pfizer·Phase 1·NCT01544673·18 enrolled

Clinical Trial1 trial

Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)

Completed·MMedecins Sans Frontieres, Netherlands·Phase 2/3·NCT02589782·552 enrolled

Streptococcal Infections1 trial

Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections

Unknown status·NNational Institutes of Health Clinical Center (CC)··NCT06126263·1,000 enrolled

Toxicity1 trial

Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients

Terminated·HHenry Ford Health System·Phase 4·NCT01734694·100 enrolled

Cancer1 trial

Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer

Terminated·FForest Laboratories·Phase 2·NCT02732327·2 enrolled

Antibiotic1 trial

AbioKin - Antibiotic Kinetics

Completed·GGruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva··NCT02609646·1,500 enrolled

Effectiveness1 trial

Cost Effectiveness Of Linezolid In Central America

Withdrawn· Pfizer logo

Pfizer··NCT01040585

Prosthetic-joint Infection1 trial

Efficacy and Safety Study of Antibiotic Treatment to Treat Hip Prosthetic Joint Infection

Unknown status·UUniversity Hospital, Tours·Phase 2·NCT01757236·100 enrolled

Septic Shock1 trial

Efficacy and Safety of Continuous Versus Intermittent Linezolid Infusion in Critically Ill Patients With Septic Shock

Unknown status·—·N/A·NCT05813951·140 enrolled

Aspirin1 trial

Linezolid, Aspirin and Enhanced Dose Rifampicin in HIV-TBM

Completed·UUniversity of Cape Town·Phase 2·NCT03927313·52 enrolled

Drug-Resistant Tuberculosis1 trial

A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis

Not yet recruiting·WWuhan Pulmonary Hospital·N/A·NCT07126639·200 enrolled

Double-blind1 trial

A Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose Study

Completed·LLigaChem Biosciences, Inc.·Phase 1·NCT01554995·70 enrolled

Diabetic Foot1 trial

Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)

Recruiting·MMicuRx·Phase 3·NCT05369052·865 enrolled

Elderly1 trial

Ultra-Short Regimen for Elderly DS-TB

Not yet recruiting·SShenzhen Third People's Hospital·Phase 3·NCT07076225·300 enrolled

Trial1 trial

A PAN-USR TB Multi-Center Trial

Recruiting·SShenzhen Third People's Hospital·Phase 3·NCT06905522·610 enrolled

Surgical Site Infection1 trial

Linezolid or Vancomycin Surgical Site Infection Prophylaxis

Recruiting·AAssistance Publique Hopitaux De Marseille·Phase 4·NCT05571722·1,160 enrolled

RR-TB1 trial

6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province

Not yet recruiting·WWuhan Pulmonary Hospital·N/A·NCT07198685·52 enrolled

Impaired Renal Function1 trial

Linezolid Pharmacokinetics In Patients With Impaired Renal Function (PPT6)

Completed·—·N/A·NCT02087566·18 enrolled

Renal Impairment1 trial

Optimizing Linezolid Dosing in Patients With Advanced Renal Impairment: a Therapeutic Drug Monitoring-based Evaluation

Not yet recruiting·—·Phase 4·NCT07138521·50 enrolled

Antibiotic Therapy1 trial

Optimized Antibiotic Therapy in Patients With Subarachnoid Haemorrhage (ES) and Cerebral Haemorrhage (EC)

Unknown status·AAzienda Sanitaria-Universitaria Integrata di Udine··NCT04132115·104 enrolled

Concentration1 trial

Steady State Serum and Epithelial Lining Fluid (ELF) Antibiotics Concentrations Under Continous Infusion

Terminated·UUniversity Hospital Tuebingen··NCT00435305·40 enrolled

Staphylococcus Aureus1 trial

Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan

Completed· Pfizer logo

Pfizer·Phase 3·NCT00150332·24 enrolled

Pregnancy1 trial

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

Surgical Site Infections1 trial

Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections

Terminated· Menarini logo

Menarini·Phase 3·NCT04042077·268 enrolled

Ventilator-Associated Pneumonia1 trial

Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus

Completed· Pfizer logo

Pfizer·Phase 4·NCT00572559·149 enrolled

Staphylococcus Aureus Bacteremia1 trial

Staphylococcus Aureus Bacteremia Antibiotic Treatment Options

Completed·HHeinrich-Heine University, Duesseldorf·Phase 3·NCT01792804·215 enrolled

Antibiotic Prophylaxis1 trial

Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

Recruiting·RRigshospitalet, Denmark·Phase 4·NCT06709196·248 enrolled

Prospective1 trial

PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT04983901·100 enrolled

Bronchitis1 trial

Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis

Terminated·UUniversity Hospital, Lille·Phase 4·NCT03012360·103 enrolled

Burns1 trial

Evaluation Of Linezolid Pk Profile In Burns Patients

Completed· Pfizer logo

Pfizer·Phase 1·NCT00255996·16 enrolled

Aging1 trial

Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India

Unknown status·TTuberculosis Research Centre, India·Phase 3·NCT05040126·400 enrolled

Impetigo1 trial

Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA

Completed· GSK logo

GSK·Phase 3·NCT00852540·410 enrolled

Linezolid1 trial

Characterizing Absorption Kinetics of Oral Antibiotics in Young Infants to Enhance Precision Dosing

Not yet recruiting·UUniversity of Colorado, Denver·Approved·NCT07815613·40 enrolled

Syphilis, Congenital1 trial

Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis

Recruiting·LLondon School of Hygiene and Tropical Medicine·Phase 2·NCT06921213·90 enrolled

Joint Infection1 trial

Randomized Open-label Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of Afabicin IV/Oral in the Treatment of Patients With Bone or Joint Infection Due to Staphylococcus

Terminated·DDebiopharm International SA·Phase 2·NCT03723551·67 enrolled

Recruiting·UUniversity Hospital, Basel, Switzerland·Preclinical·NCT06958835·606 enrolled

Tuberculosis, Multidrug-Resistant1 trial

Prospective, Randomized, Partially Blinded, Phase 2 Study of the Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine for Treatment of Patients With MDR-TB

Active, not recruiting·BBoston University·Phase 2·NCT03828201·271 enrolled

Endocarditis1 trial

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Recruiting·FFundacion Clinic per a la Recerca Biomédica·Approved·NCT05398679·360 enrolled

Pulmonary TB1 trial

A Phase 2, Partially-blinded, Randomised Trial Assessing the Safety and Efficacy of TBAJ-876 or Bedaquiline, in Combination With Pretomanid and Linezolid in Adult Participants With Newly Diagnosed, Drug-sensitive, Smear-positive Pulmonary Tuberculosis

Active, not recruiting·GGlobal Alliance for TB Drug Development·Phase 2·NCT06058299·309 enrolled

Unspecified4 trials

Post Marketing Surveillance Study on Linezolid

Completed· Pfizer logo

Pfizer··NCT01564758·99 enrolled

Model-informed Precision Dosing for Linezolid

Not yet recruiting·UUniversity of Hamburg-Eppendorf·Phase 3·NCT06444802·28 enrolled

Economic Evaluation of New MDR TB Regimens

Completed·MMedecins Sans Frontieres, Netherlands·Phase 2/3·NCT04207112·73 enrolled

Show 1 more trial

PRACTECAL-PKPD Sub Study

Unknown status·MMedecins Sans Frontieres, Netherlands·Phase 2/3·NCT04081077·240 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 18, 2000

ZYVOX

NDA NDA021132

Apr 18, 2000

ZYVOX

NDA NDA021131

Apr 18, 2000

ZYVOX

NDA NDA021130

Apr 18, 2000

ZYVOX

NDA NDA021131

Apr 18, 2000

ZYVOX

NDA NDA021132

Apr 18, 2000

ZYVOX

NDA NDA021130

Dec 19, 2002

ZYVOX

NDA NDA021130

Dec 19, 2002

ZYVOX

NDA NDA021131

Dec 19, 2002

ZYVOX

NDA NDA021132

Dec 19, 2002

ZYVOX

NDA NDA021131

Dec 19, 2002

ZYVOX

NDA NDA021132

Dec 19, 2002

ZYVOX

NDA NDA021130

Jul 22, 2003

ZYVOX

NDA NDA021131

Jul 22, 2003

ZYVOX

NDA NDA021132

Jul 22, 2003

ZYVOX

NDA NDA021130

Jan 5, 2004

ZYVOX

NDA NDA021131

Jan 5, 2004

ZYVOX

NDA NDA021132

Jan 5, 2004

ZYVOX

NDA NDA021130

Jun 23, 2004

ZYVOX

NDA NDA021132

Jun 23, 2004

ZYVOX

NDA NDA021130

Jun 23, 2004

ZYVOX

NDA NDA021131

Feb 10, 2005

ZYVOX

NDA NDA021131

Feb 10, 2005

ZYVOX

NDA NDA021130

Feb 10, 2005

ZYVOX

NDA NDA021132

May 12, 2005

ZYVOX

NDA NDA021132

May 12, 2005

ZYVOX

NDA NDA021131

May 12, 2005

ZYVOX

NDA NDA021131

May 12, 2005

ZYVOX

NDA NDA021132

May 12, 2005

ZYVOX

NDA NDA021130

May 12, 2005

ZYVOX

NDA NDA021130

Nov 2, 2005

ZYVOX

NDA NDA021131

Nov 2, 2005

ZYVOX

NDA NDA021130

Nov 2, 2005

ZYVOX

NDA NDA021132

Mar 21, 2007

ZYVOX

NDA NDA021130

Mar 26, 2007

ZYVOX

NDA NDA021132

Mar 26, 2007

ZYVOX

NDA NDA021130

Apr 26, 2007

ZYVOX

NDA NDA021131

Apr 26, 2007

ZYVOX

NDA NDA021130

Apr 26, 2007

ZYVOX

NDA NDA021132

Jun 8, 2007

ZYVOX

NDA NDA021130

Aug 2, 2007

ZYVOX

NDA NDA021131

Sep 18, 2007

ZYVOX

NDA NDA021130

Sep 18, 2007

ZYVOX

NDA NDA021132

Sep 18, 2007

ZYVOX

NDA NDA021131

Feb 19, 2008

ZYVOX

NDA NDA021130

Jun 20, 2008

ZYVOX

NDA NDA021130

Jun 20, 2008

ZYVOX

NDA NDA021130

Jun 20, 2008

ZYVOX

NDA NDA021131

Jun 20, 2008

ZYVOX

NDA NDA021132

Jun 20, 2008

ZYVOX

NDA NDA021132

Jun 20, 2008

ZYVOX

NDA NDA021131

Dec 8, 2009

ZYVOX

NDA NDA021130

Dec 8, 2009

ZYVOX

NDA NDA021132

Dec 8, 2009

ZYVOX

NDA NDA021131

Jul 16, 2010

ZYVOX

NDA NDA021132

Jul 16, 2010

ZYVOX

NDA NDA021130

Jul 16, 2010

ZYVOX

NDA NDA021131

Feb 13, 2012

ZYVOX

NDA NDA021132

Feb 13, 2012

ZYVOX

NDA NDA021131

Feb 13, 2012

ZYVOX

NDA NDA021130

May 3, 2013

ZYVOX

NDA NDA021131

May 3, 2013

ZYVOX

NDA NDA021132

May 3, 2013

ZYVOX

NDA NDA021130

May 3, 2013

ZYVOX

NDA NDA021132

May 3, 2013

ZYVOX

NDA NDA021130

May 3, 2013

ZYVOX

NDA NDA021131

Oct 9, 2013

ZYVOX

NDA NDA021132

Jan 24, 2014

ZYVOX

NDA NDA021132

Jan 24, 2014

ZYVOX

NDA NDA021131

Jan 24, 2014

ZYVOX

NDA NDA021130

Jul 28, 2014

ZYVOX

NDA NDA021131

Jul 28, 2014

ZYVOX

NDA NDA021130

Jul 28, 2014

ZYVOX

NDA NDA021132

Jun 5, 2015

ZYVOX

NDA NDA021132

Jun 5, 2015

ZYVOX

NDA NDA021130

Jun 5, 2015

ZYVOX

NDA NDA021131

Jun 18, 2015

LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

NDA NDA206473

Jul 13, 2017

ZYVOX

NDA NDA021130

Jul 13, 2017

ZYVOX

NDA NDA021132

Jul 13, 2017

ZYVOX

NDA NDA021131

Feb 1, 2018

ZYVOX

NDA NDA021132

Feb 1, 2018

ZYVOX

NDA NDA021130

Feb 1, 2018

ZYVOX

NDA NDA021131

Aug 5, 2020

ZYVOX

NDA NDA021130

Aug 5, 2020

ZYVOX

NDA NDA021130

Aug 5, 2020

ZYVOX

NDA NDA021132

Aug 5, 2020

ZYVOX

NDA NDA021131

Aug 5, 2020

ZYVOX

NDA NDA021132

Aug 5, 2020

ZYVOX

NDA NDA021131

Jul 16, 2021

ZYVOX

NDA NDA021130

Jul 16, 2021

ZYVOX

NDA NDA021131

Jul 16, 2021

ZYVOX

NDA NDA021132

Sep 1, 2021

ZYVOX

NDA NDA021131

Sep 1, 2021

ZYVOX

NDA NDA021130

Sep 1, 2021

ZYVOX

NDA NDA021132

Oct 26, 2021

ZYVOX

NDA NDA021131

Oct 26, 2021

ZYVOX

NDA NDA021132

Oct 26, 2021

ZYVOX

NDA NDA021130

Nov 10, 2021

ZYVOX

NDA NDA021131

Jul 18, 2023

ZYVOX

NDA NDA021130

Jul 18, 2023

ZYVOX

NDA NDA021132

Jul 18, 2023

ZYVOX

NDA NDA021131

Jun 27, 2024

ZYVOX

NDA NDA021131

Jun 27, 2024

ZYVOX

NDA NDA021130

Jun 27, 2024

ZYVOX

NDA NDA021132

Jun 9, 2026

ZYVOX

NDA NDA021131

Jun 9, 2026

ZYVOX

NDA NDA021132

Jun 9, 2026

ZYVOX

NDA NDA021130

Sources

References

[1]
ClinicalTrials.gov — 130 trial records for Linezolid. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zyvox drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Linezolid compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Linezolid. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021131). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial 70s Ribosome Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Zyvox

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Tuberculosis10 trials

Treatment8 trials

Pneumonia7 trials

Infections5 trials

Skin Infection5 trials

Meningitis4 trials

Efficacy and Safety4 trials

Bacterial Pneumonia4 trials

Safety and Efficacy3 trials

Abscess3 trials

Methicillin-resistant Staphylococcus Aureus3 trials

Drug3 trials

Hospitalized Patients2 trials

Pulmonary Tuberculosis2 trials

Efficacy2 trials

Cystic Fibrosis2 trials

Intravenous2 trials

ESS2 trials

Thrombocytopenia2 trials

Tics2 trials

Adult2 trials

Multidrug-Resistant Tuberculosis2 trials

Tuberculosis, Pulmonary2 trials

Antibiotics1 trial

Oral1 trial

Quality of Life1 trial

Adult Subject1 trial

Function1 trial

Clinical Trial1 trial

Streptococcal Infections1 trial

Toxicity1 trial

Cancer1 trial

Antibiotic1 trial

Effectiveness1 trial

Prosthetic-joint Infection1 trial

Septic Shock1 trial

Aspirin1 trial

Drug-Resistant Tuberculosis1 trial

Double-blind1 trial

Diabetic Foot1 trial

Elderly1 trial

Trial1 trial

Surgical Site Infection1 trial

RR-TB1 trial

Impaired Renal Function1 trial

Renal Impairment1 trial

Antibiotic Therapy1 trial

Concentration1 trial

Staphylococcus Aureus1 trial

Pregnancy1 trial

Surgical Site Infections1 trial

Ventilator-Associated Pneumonia1 trial

Staphylococcus Aureus Bacteremia1 trial

Antibiotic Prophylaxis1 trial

Prospective1 trial

Bronchitis1 trial

Burns1 trial

Aging1 trial

Impetigo1 trial

Linezolid1 trial

Syphilis, Congenital1 trial

Joint Infection1 trial

Early Latent Syphilis1 trial

Yaws1 trial

Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)1 trial

Tuberculosis, Multidrug-Resistant1 trial

Endocarditis1 trial

Pulmonary TB1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info