Data updated: May 26, 2026
ZYVOX (linezolid)
Infectious Disease
Approved 2000-04-18
ZYVOX is indicated for the treatment of Nosocomial Pneumonia; Community-Acquired Pneumonia; Complicated Skin and Skin Structure Infections; Diabetic Foot Infections; Uncomplicated Skin and Skin Structure Infections; Enterococcus faecium Infections.
How ZYVOX Works
Linezolid is a synthetic antibacterial agent that inhibits bacterial protein synthesis by binding to the 23S ribosomal RNA of the 50S subunit. This binding prevents the formation of the functional 70S initiation complex, which is an essential step in the bacterial translation process. Because of this unique mechanism of action, cross-resistance between linezolid and other protein synthesis inhibitors (such as aminoglycosides, lincosamides, or macrolides) is uncommon. Linezolid is generally bacteriostatic against enterococci and staphylococci, and bactericidal against most strains of streptococci.
5
Indications
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Phase 3 Trials
4
Priority Reviews
26
Years on Market
Details
- Status
- Prescription
- First Approved
- 2000-04-18
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- FOR SUSPENSION, TABLET, SOLUTION
ZYVOX Approval History
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
208 FDA actions from 2000 to 2024 · 2 indication expansions
Jul 2014 SUPPL Priority
Mfg
Oct 2013 SUPPL Priority
Mfg
Feb 2008 SUPPL Priority
Mfg
Sep 2007 SUPPL Priority
Mfg
Aug 2007 SUPPL Priority
Mfg
Jun 2007 SUPPL Priority
Mfg
Mar 2007 SUPPL Priority
Mfg
Mar 2007 SUPPL Priority
Mfg
Feb 2001 SUPPL
Label
What ZYVOX Treats
6 indicationsZYVOX is approved for 6 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nosocomial Pneumonia
- Community-Acquired Pneumonia
- Complicated Skin and Skin Structure Infections
- Diabetic Foot Infections
- Uncomplicated Skin and Skin Structure Infections
- Enterococcus faecium Infections
Source: FDA Label
ZYVOX Competitive Set
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Shared indications:
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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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Trial Timeline
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.
ZYVOX FDA Label Details
Indications & Usage
FDA Label (PDF)ZYVOX is indicated for the treatment of Nosocomial Pneumonia; Community-Acquired Pneumonia; Complicated Skin and Skin Structure Infections; Diabetic Foot Infections; Uncomplicated Skin and Skin Structure Infections; Enterococcus faecium Infections.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.