Linezolid
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | ZYVOX | — | 2002-12-19 – 2005-05-12 | fda.gov ↗ |
| Approved | US (FDA) | ZYVOX | — | 2000-04-18 | fda.gov ↗ |
Trials 96 · started per year
Also used as a comparator or background therapy in 75 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT07228702 Background | Jan 2026 → Oct 2027 expected | pulmonary non-tuberculous mycobacterial infection | Vancouver Coastal Health | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT01544673 Comparator | Mar → Apr 2012 | gram-positive bacterial infections | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00925093 Comparator | Sep 2011 → Dec 2012 | — | Aarhus University Hospital | Withdrawn | No outcome recorded |
| Phase 1 | NCT01039610 Comparator | Nov 2009 → Aug 2010 | bacterial infectious disease | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT00671814 Comparator | Jan → Jun 2008 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06811025 Comparator | Feb 2024 → Dec 2025 overdue | meningitis, tuberculosis | Beijing Chest Hospital | Enrolling by invitation | No outcome recorded |
| Phase 1/2 | NCT06811012 Comparator | Jan 2024 → Dec 2025 overdue | disease of bone structure, tuberculosis | Beijing Chest Hospital | Enrolling by invitation | No outcome recorded |
| Phase 222 trials | ||||||
| Phase 2 | NCT07517445 Comparator | Apr 2026 → Jun 2027 expected | primary pulmonary tuberculosis | Gates Medical Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT07525427 Comparator | Apr → Nov 2026 expected | pulmonary tuberculosis | Gates Medical Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT07372781 Comparator | Jan → Dec 2026 expected | mycobacterial infectious disease | Beijing Chest Hospital | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07170800 Background | Sep 2025 → Feb 2026 overdue | multidrug-resistant tuberculosis, rifampicin-resistant tuberculosis | WestVac Biopharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT05339802 Background | Feb 2022 → Oct 2023 | skin infection | Mabwell (Shanghai) Bioscience Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04983901 Background | Sep 2021 → Oct 2023 | cancer, hematopoietic and lymphoid cell neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03747497 Comparator | Nov 2018 → Mar 2019 | gram-positive bacterial infections, skin disease caused by bacterial infection | MicuRx | Completed | No outcome recorded |
| Phase 2 | NCT02836483 Comparator | Dec 2016 → Jul 2019 | pulmonary tuberculosis | LigaChem Biosciences, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02732327 Background | May → Jun 2016 | neoplasm, neutropenia | Forest Laboratories | Terminated | No outcome recorded |
| Phase 2 | NCT02426918 Comparator | May 2015 → Aug 2016 | bacterial infectious disease | Debiopharm International SA | Completed | No outcome recorded |
| Phase 2 | NCT02365623 Background | Feb 2015 → Nov 2018 | multidrug-resistant tuberculosis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT02269319 Comparator | Feb → Aug 2015 | bacterial infectious disease | MicuRx | Completed | No outcome recorded |
| Phase 2 | NCT02168816 Comparator | Mar 2014 → Feb 2017 | osteomyelitis | Loyola University | Terminated | No outcome recorded |
| Phase 2 | NCT01756924 Comparator | Dec 2012 → Jul 2014 | periprosthetic joint infection | Arrevus Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01283581 Comparator | Jan → Nov 2011 | skin disease caused by bacterial infection | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01570192 Background | Sep 2010 → Apr 2015 | bacterial pneumonia | University of Florida | Terminated | No outcome recorded |
| Phase 2 | NCT01128530 Comparator | Jun → Dec 2010 | — | Furiex Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 2 | NCT00949130 Comparator | Nov 2009 → Mar 2010 | — | Novexel Inc | Completed | No outcome recorded |
| Phase 2 | NCT00948142 Comparator | Aug 2009 → Mar 2010 | skin disease caused by bacterial infection | Arrevus Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00633152 Comparator | Feb → Jul 2008 | bacterial infectious disease | Forest Laboratories | Completed | No outcome recorded |
| Phase 2 | NCT00646958 Comparator | Dec 2007 → Apr 2008 | abscess, skin disease caused by bacterial infection, staphylococcal infection, streptococcal infection | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03716024 Comparator | Jul 2007 → Jan 2008 | skin disease caused by bacterial infection, skin infection | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05293132 Background | Feb 2022 → Jun 2023 | infectious disease with sepsis | Ain Shams University | Completed | No outcome recorded |
| Phase 2/3 | NCT02191475 Comparator | May 2014 → May 2017 | digestive system infectious disorder | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT01400867 Background | Dec 2011 → May 2014 | primary bacterial infectious disease | Forest Laboratories | Completed | No outcome recorded |
| Phase 329 trials | ||||||
| Phase 3 | NCT07435051 Background | May 2026 → Dec 2029 expected | osteomyelitis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06081361 Comparator | Dec 2023 → Oct 2026 expected | pulmonary tuberculosis, rifampicin-resistant tuberculosis | Beijing Chest Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05369052 Comparator | May 2022 → Jun 2026 overdue | — | MicuRx | Recruiting | No outcome recorded |
| Phase 3 | NCT04042077 Comparator | Sep 2019 → Oct 2020 | — | Menarini Group | Terminated | No outcome recorded |
| Phase 3 | NCT04062201 Comparator | Aug 2019 → Apr 2024 | extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, rifampicin-resistant tuberculosis | Wits Health Consortium (Pty) Ltd | Completed | No outcome recorded |
| Phase 3 | NCT03176134 Comparator | Jan 2019 → Jul 2023 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03583333 Background | Sep 2018 → Jul 2022 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03032380 Background | Oct 2017 → Feb 2019 | lung disorder | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT02679573 Comparator | Dec 2016 → Jul 2018 | bacterial pneumonia | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02877927 Comparator | Aug 2016 → May 2017 | bacterial infectious disease | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 3 | NCT02493764 Background | Nov 2015 → Apr 2019 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02570490 Comparator | Nov 2015 → Nov 2016 | — | Arrevus Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02269644 Comparator | Nov 2015 → Nov 2016 | — | Durata Therapeutics Inc., an affiliate of Allergan plc | Withdrawn | No outcome recorded |
| Phase 3 | NCT02559310 Comparator | Sep 2015 → Apr 2017 | — | Nabriva Therapeutics AG | Completed | No outcome recorded |
| Phase 3 | NCT02378480 Comparator | Jun 2015 → Apr 2016 | bacterial infectious disease | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 3 | NCT02276482 Comparator | Mar 2015 → Sep 2018 | skin disease caused by bacterial infection, skin infection | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02066402 Comparator | Mar 2014 → Mar 2016 | bacterial infectious disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT02019420 Comparator | Jan 2014 → Jun 2018 | pneumonia | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01967225 Comparator | Nov 2013 → Oct 2016 | skin infection | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01421511 Comparator | Sep 2011 → Jan 2013 | skin disease caused by bacterial infection | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01431339 Comparator | Jul 2011 → Nov 2012 | abscess, cellulitis, skin infection | Durata Therapeutics Inc., an affiliate of Allergan plc | Completed | No outcome recorded |
| Phase 3 | NCT01339091 Comparator | Mar 2011 → Sep 2012 | abscess, cellulitis, skin infection | Durata Therapeutics Inc., an affiliate of Allergan plc | Completed | No outcome recorded |
| Phase 3 | NCT01170221 Comparator | Aug 2010 → Sep 2011 | skin disease caused by bacterial infection | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00876850 Comparator | Jul 2009 → Jul 2010 | — | Paratek Pharmaceuticals Inc | Withdrawn | No outcome recorded |
| Phase 3 | NCT00865280 Comparator | Apr 2009 → Apr 2010 | skin infection | Paratek Pharmaceuticals Inc | Terminated | No outcome recorded |
| Phase 3 | NCT00852540 Comparator | Apr 2009 → Jul 2010 | skin disease caused by bacterial infection | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 3 | NCT00326287 Comparator | Jun 2006 → Jul 2007 | pneumonia | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT00229008 Comparator | Nov 2005 → May 2007 | pneumonia | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 3 | NCT00210964 Comparator | Apr 2005 → May 2007 | pneumonia | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT07301294 Comparator | Jan → Jun 2026 overdue | — | Menoufia University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05977868 Background | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT05494957 Background | Aug 2022 → Aug 2024 | pulmonary non-tuberculous mycobacterial infection | Shanghai Pulmonary Hospital, Shanghai, China | Unknown | No outcome recorded |
| Phase 4 | NCT05206500 Background | May 2022 → Dec 2028 expected | urinary tract infection | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT05306223 Background | May 2022 → Aug 2025 | multidrug-resistant tuberculosis | Beijing Chest Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01951768 Comparator | Sep 2013 → Jun 2016 | ulcer of lower limbs | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 4 | NCT01669980 Background | Oct 2012 → May 2014 | pneumonia | Forest Laboratories | Completed | No outcome recorded |
| Phase 4 | NCT01734694 Comparator | Oct 2011 → Sep 2012 | bacterial infectious disease, endocarditis, nosocomial infection, osteomyelitis | Henry Ford Health System | Terminated | No outcome recorded |
| Phase 4 | NCT00711854 Comparator | Jan 2009 → Dec 2013 | methicillin-resistant staphylococcus aureus infectious disease | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 4 | NCT02123628 Comparator | Jun 2007 → Jun 2010 | diabetes mellitus | Tourcoing Hospital | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07198685 Background | Sep 2025 → Sep 2027 expected | — | Wuhan Pulmonary Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05813951 Comparator | Dec 2022 → Dec 2023 | — | Ain Shams University | Unknown | No outcome recorded |
| — | NCT01619410 Comparator | Jan 2012 → Dec 2016 | abscess, skin disease caused by bacterial infection | University of Chicago | Terminated | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2015-02-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Bolsters Injectable Portfolio with Launch of Generic Lovenox® and Generic Zyvox® in the United States tevapharm.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 176 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Linezolid | “The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for 24 weeks or Bedaquiline, Pretomanid,...” NCT05381194 ↗170“empiric initiation of the enhanced spectrum antimicrobial therapy regimen (rifampin, isoniazid, linezolid, and levofloxacin) for 14 days plus standard care which includes...” NCT07332325 ↗ “This therapy is usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin,...” NCT02168816 ↗ “Other drugs are used less commonly, such as amoxicillin-clavulanate, linezolid and clofazimine based on Investigator's decision twice a week from Day 1 up to 78 weeks after...” NCT02365623 ↗ “Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral provided locally by the...” NCT03176134 ↗ “Experimental arms are seven oral regimens with a five-drug combination of the following: bedaquiline, linezolid, a fluoroquinolone (moxifloxacin or levofloxacin), cycloserine,...” NCT05081401 ↗ “Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks + Moxifloxacin...” NCT07209761 ↗ “For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV...” NCT00865280 ↗ “In addition, some new antibiotics or anti-tuberculosis drugs have attracted attention for showing good anti-NTM effects in in vitro experiments, such as tigecycline, linezolid,...” NCT05494957 ↗ “The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid” NCT03830671 ↗ “Antibiotic comparator drug, IV and/or orally for 10 days. Antibiotic comparator included the following: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin.” NCT02276482 ↗ “Here we characterize the safety, tolerability, and pharmacokinetics of PP353, a suspension of micronized linezolid, formulated for direct intervertebral disc administration.” PMID 39544354 ↗ Nov 2024 “using oral high-dose rifampicin (35 mg/kg daily) and linezolid (1200 mg daily and then 600 mg daily) during the first 8 weeks of the anti-TB treatment” PMID 36348453 ↗ Nov 2022 “Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study” NCT00035269 ↗ “or an active control of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) or linezolid 600 mg BID.” PMID 34871098 ↗ Dec 2021 “oral linezolid 600mg./day for the treatment of 40 patients with nontuberculous mycobacterial diseases” NCT03220074 ↗ “ceftriaxone 2gm/24 hour or meropenem 1g/8 hours, linezolid 600/12hours” NCT05293132 ↗ “such as linezolid, clofazimine or ethambutol based on the DST results” NCT03604848 ↗ “bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide” NCT07227779 ↗ “PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h” NCT01669980 ↗ “Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h” NCT01951768 ↗ “pretomanid, linezolid, sutezolid, clofazimine” NCT03237182 ↗ “sequential oral linezolid for total 6 weeks” NCT07435051 ↗ “* Linezolid IV and PO 600mg twice daily” NCT02123628 ↗ “or linezolid 300mg, IVdrip, 2 times/d” NCT02191475 ↗ “Drug:linezolid Scored 600mg tablets” NCT06476210 ↗ “Linezolid: 600 mg/12 hours (i.v)” NCT05394298 ↗ “Linezolid (L): 600 mg qd.” NCT07170800 ↗ “Linezolid: 600 mg daily” NCT03867136 ↗ “Linezolid (LZD):” NCT07268664 ↗ “Linezolid*” NCT02099240 ↗ “Linezolid” NCT05206500 ↗ |
| Known as | Linezolid (Zyvox) | “Linezolid (Zyvox)” NCT02168816 ↗ |
| Known as | linezolid: zyloxid 2 mg/ml, 300 ml vial. | “linezolid: zyloxid 2 mg/ml, 300 ml vial.” NCT01592032 ↗ |
| Known as | Linezolide | ChEMBL registry synonym — accepted as the source's own label CHEMBL126 ↗ |
| Known as | LZD | “Our objective is to evaluate the effectiveness, safety and tolerability of various doses and duration of linezolid (LZD) in combination with bedaquiline (BDQ) and pretomanid...” PMID 36038181 ↗ Aug 202214“The Trep-AB clinical trial will test the efficacy of an investigational neuropenetrative drug, Linezolid (LZD), compared to standard treatment, Benzathine penicillin G (BPG),...” NCT05069974 ↗ “6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) , as known as BDLL regimen” NCT07198685 ↗ “Renal failure patients were treated with linezolid (LZD) for proven or suspected infections by multiresistant Gram-positive cocci.” NCT02087566 ↗ “A six - month regimen containing bedaquiline (BDQ), pretomanid (Pa), linezolid (LZD), and moxifloxacin (MFX)” NCT07126639 ↗ “Regimen A (bedaquiline [Bdq]+linezolid [Lzd]+moxifloxacin [Mfx]+cycloserine [Cs]+pyrazinamide [Pza])” PMID 37567554 ↗ Aug 2023 “guide linezolid (LZD) dose selection using early bactericidal activity over 14 days of treatment.” PMID 39016594 ↗ Jul 2024 “linezolid (LZD) therapy with that of vancomycin (VAN) therapy” PMID 18719064 ↗ Aug 2008 “Drug: Linezolid (LZD)” NCT07301294 ↗ “Drug: Linezolid (LZD)” NCT05383742 ↗ “Linezolid (LZD):” NCT07268664 ↗ “Linezolid (LZD)” NCT06811012 ↗ “Linezolid (LZD)” NCT06921213 ↗ “Linezolid (LZD)” NCT06811025 ↗ “Linezolid (LZD)” NCT07228702 ↗ |
| Known as | Lzd-linezolid | “The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid” NCT03830671 ↗ |
| Known as | Pnu-100766 | ChEMBL registry synonym — accepted as the source's own label CHEMBL126 ↗ |
| Known as | U-100,766 | ChEMBL registry synonym — accepted as the source's own label CHEMBL126 ↗ |
| Known as | Zyvox | “A Randomized, Evaluator-Blinded, Phase 2 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid (Zyvox®) in the Treatment of Adults With Complicated Skin and Skin...” NCT03716024 ↗ |
| Known as | Zyvox, linezolid | “Zyvox, linezolid” NCT00084266 ↗ |
| Known as | ZYVOXID | “Linezolid (ZYVOXID®)” NCT05534750 ↗ |
| Action | Inhibit | “works by inhibiting ribosomal protein synthesis” NCT04081077 ↗ |
| Modality | Other / unclassified | “Linezolid is the first of a new class of antibacterial drugs, the oxazolidinones.” NCT01200654 ↗ |
| Route | Intravenous | “Linezolid IV/PO” NCT00035854 ↗ |
| Route | Oral | “Linezolid IV/PO” NCT00035854 ↗ |