Drugs / Linezolid
Linezolid
also known as
LZD · Zyvox · Linezolid (Zyvox) · linezolid: zyloxid 2 mg/ml, 300 ml vial. · Linezolide · Lzd-linezolid · Pnu-100766 · U-100,766 · +2 more
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 ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT03841721 | May → Aug 2018 | — | Prince of Songkla University | Unknown | No outcome recorded |
| Phase 1 | NCT01554995 | Mar → Dec 2012 | — | LigaChem Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00990990 | Oct 2009 → May 2010 | tuberculosis | Sequella, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00795145 | Dec 2008 → Mar 2009 | bacterial infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00255996 | May 2006 → Jan 2007 | — | Pfizer | Completed | No outcome recorded |
| Phase 1/23 trials · 1 met primary | ||||||
| Phase 1/2 | NCT04238676 | Jan 2020 → Dec 2024 | chronic pain syndrome | Persica Pharmaceuticals Ltd | Completed | Met primary |
| Phase 1/2 | NCT00664313 | Apr 2009 → Sep 2010 | extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase 1/2 | NCT00396084 | Feb 2004 → Nov 2007 | tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 223 trials · 2 met primary · 2 missed | ||||||
| Phase 2 | NCT07485010 | Apr 2027 → Apr 2031 expected | pulmonary non-tuberculous mycobacterial infection | The University of Queensland | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07773610 | Sep 2026 → Dec 2027 expected | pulmonary tuberculosis | TASK Applied Science | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07227779 | Jul 2026 → Mar 2028 expected | HIV infectious disease, meningeal tuberculosis | David Boulware | Recruiting | No outcome recorded |
| Phase 2 | NCT07672405 | Jul 2026 → May 2027 expected | pulmonary tuberculosis | Global Alliance for TB Drug Development | Recruiting | No outcome recorded |
| Phase 2 | NCT06921213 | May 2026 → Mar 2027 expected | congenital syphilis | London School of Hygiene and Tropical Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT06192160 | Mar 2025 → Nov 2026 expected | pulmonary tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT06114628 | Jan 2024 → Feb 2027 expected | pulmonary tuberculosis | University College, London | Recruiting | No outcome recorded |
| Phase 2 | NCT05383742 | Dec 2023 → Apr 2028 expected | meningeal tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT06058299 | Oct 2023 → Dec 2024 overdue | pulmonary tuberculosis | Global Alliance for TB Drug Development | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05548426 | Sep 2023 → Aug 2026 overdue | syphilis | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05534750 | Apr 2023 → Apr 2026 overdue | multidrug-resistant tuberculosis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT05007821 | Sep 2022 → Mar 2025 | multidrug-resistant tuberculosis, pulmonary tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT05382312 | Jul 2022 → May 2025 | tuberculosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT03828201 | Jun 2022 → May 2027 expected | multidrug-resistant tuberculosis | Boston University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03537495 | Jun 2021 → Mar 2023 | meningeal tuberculosis | Padjadjaran University | Completed | No outcome recorded |
| Phase 2 | NCT03927313 | Jun 2019 → Mar 2021 | HIV infectious disease, meningeal tuberculosis | University of Cape Town | Completed | No outcome recorded |
| Phase 2 | NCT02619994 | Jan 2016 → Jun 2021 | multidrug-resistant tuberculosis | Seoul National University Hospital | Completed | Met primary |
| Phase 2 | NCT02279875 | Nov 2014 → Nov 2016 | pulmonary tuberculosis | Global Alliance for TB Drug Development | Completed | No outcome recorded |
| Phase 2 | NCT01994460 | Jan 2014 → Dec 2015 | pulmonary tuberculosis | Seoul National University Hospital | Unknown | Missed primary |
| Phase 2 | NCT01757236 | Oct 2012 → Apr 2016 | periprosthetic joint infection | University Hospital, Tours | Unknown | No outcome recorded |
| Phase 2 | NCT00625703 | Dec 2010 → May 2011 | cystic fibrosis | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01209078 | Aug 2010 → Jan 2011 | skin disease caused by bacterial infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00727844 | Jul 2008 → Oct 2012 | extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, pulmonary tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 2/37 trials · 2 met primary | ||||||
| Phase 2/3 | NCT06441006 | Oct 2025 → Aug 2031 expected | multidrug-resistant tuberculosis, pulmonary tuberculosis | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04207112 | Oct 2020 → Aug 2022 | extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, pulmonary tuberculosis | Medecins Sans Frontieres, Netherlands | Completed | No outcome recorded |
| Phase 2/3 | NCT04310930 | Mar 2020 → Jun 2029 expected | pulmonary non-tuberculous mycobacterial infection | The University of Queensland | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04081077 | Aug 2019 → Sep 2022 | extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, pulmonary tuberculosis | Medecins Sans Frontieres, Netherlands | Unknown | No outcome recorded |
| Phase 2/3 | NCT03474198 | Mar 2018 → Jan 2022 | pulmonary tuberculosis | University College, London | Completed | Mixed |
| Phase 2/3 | NCT02589782 | Jan 2017 → Aug 2022 | extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, pulmonary tuberculosis | Medecins Sans Frontieres, Netherlands | Completed | Met primary |
| Phase 2/3 | NCT02454205 | Nov 2015 → Dec 2020 | extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis | University of Cape Town | Completed | Met primary |
| Phase 329 trials · 2 met primary · 2 missed | ||||||
| Phase 3 | NCT07332325 | Oct 2026 → Mar 2029 expected | infectious disease with sepsis, tuberculosis | University of Virginia | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07268664 | Dec 2025 → May 2028 expected | pulmonary tuberculosis, rifampicin-resistant tuberculosis | Beijing Chest Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07209761 | Oct 2025 → May 2027 expected | pulmonary tuberculosis | Otsuka Pharmaceutical Development & Commercialization, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07076225 | Jul 2025 → Jan 2030 expected | pulmonary tuberculosis | Shenzhen Third People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06905522 | Jun 2025 → Jan 2029 expected | pulmonary tuberculosis | Shenzhen Third People's Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT06649721 | Nov 2024 → Feb 2027 expected | pulmonary tuberculosis, rifampicin-resistant tuberculosis | Huashan Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06444802 | Sep 2024 → Feb 2026 | gram-positive bacterial infections | University of Hamburg-Eppendorf | Unknown | No outcome recorded |
| Phase 3 | NCT06336824 | Jun 2024 → May 2025 overdue | staphylococcus aureus infection | Clinical Research Centre, Malaysia | Recruiting | No outcome recorded |
| Phase 3 | NCT05764876 | Mar 2023 → Jun 2024 | ulcer disease, yaws | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 3 | NCT05081401 | May 2022 → Dec 2026 expected | extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, rifampicin-resistant tuberculosis | Huashan Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05069974 | Oct 2021 → Apr 2026 | latent early syphilis, primary syphilis, secondary syphilis | Fight AIDS and Infectious Diseases Foundation | Completed | Missed primary |
| Phase 3 | NCT05040126 | Oct 2021 → Dec 2024 | multidrug-resistant tuberculosis | Tuberculosis Research Centre, India | Unknown | No outcome recorded |
| Phase 3 | NCT04145258 | Feb 2021 → Sep 2026 overdue | meningeal tuberculosis | ANRS, Emerging Infectious Diseases | Recruiting | No outcome recorded |
| Phase 3 | NCT03896685 | Apr 2020 → Oct 2024 | gram-positive bacterial infections, multidrug-resistant tuberculosis, pulmonary tuberculosis | Doctors Without Borders | Completed | Missed primary |
| Phase 3 | NCT03086486 | Nov 2017 → Feb 2021 | extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, pulmonary tuberculosis | Global Alliance for TB Drug Development | Completed | No outcome recorded |
| Phase 3 | NCT03405064 | Aug 2017 → Sep 2018 | — | Wockhardt | Completed | Met primary |
| Phase 3 | NCT02975570 | Aug 2017 → Aug 2021 | multidrug-resistant tuberculosis | Boston University | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02754765 | Dec 2016 → Jun 2023 | multidrug-resistant tuberculosis, pulmonary tuberculosis | Doctors Without Borders | Completed | Mixed |
| Phase 3 | NCT02333799 | Mar 2015 → Jan 2019 | pulmonary tuberculosis | Global Alliance for TB Drug Development | Completed | No outcome recorded |
| Phase 3 | NCT01792804 | Dec 2013 → Mar 2020 | staphylococcus aureus infection | Heinrich-Heine University, Duesseldorf | Completed | Met primary |
| Phase 3 | NCT00359632 | Nov 2008 → Dec 2013 | optic nerve disorder | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00303550 | Mar 2006 → ? | skin disease caused by bacterial infection | Arpida AG | Completed | No outcome recorded |
| Phase 3 | NCT00108433 | Sep 2005 → Sep 2006 | gram-positive bacterial infections | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00299520 | Jun 2005 → Jul 2006 | — | Arpida AG | Completed | No outcome recorded |
| Phase 3 | NCT00150332 | Jan 2003 → Jan 2006 | nosocomial infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00037050 | Apr 2002 → Jul 2005 | gram-positive bacterial infections | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00035854 | Feb 2002 → May 2004 | bacterial infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00035269 | Dec 2001 → May 2003 | streptococcal pneumonia | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00035425 | Nov 2001 → Nov 2002 | neutropenia | Pfizer | Completed | No outcome recorded |
| Phase 422 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07815613 | Jan 2027 → Dec 2029 expected | — | University of Colorado, Denver | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07477119 | Apr 2026 → Oct 2027 expected | multidrug-resistant tuberculosis | Marco Schiuma | Recruiting | No outcome recorded |
| Phase 4 | NCT07138521 | Oct → Dec 2025 overdue | kidney disorder | Alexandria University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06709196 | Jan 2025 → Jan 2027 expected | urinary bladder cancer | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| Phase 4 | NCT05571722 | Nov 2024 → Dec 2028 expected | — | Assistance Publique Hopitaux De Marseille | Recruiting | No outcome recorded |
| Phase 4 | NCT06476210 | Jun 2024 → Jun 2025 | pulmonary tuberculosis | Beijing Chest Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05381194 | Dec 2022 → Dec 2027 expected | multidrug-resistant tuberculosis | Asan Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05398679 | Aug 2022 → Dec 2026 expected | infective endocarditis | Fundacion Clinic per a la Recerca Biomédica | Recruiting | No outcome recorded |
| Phase 4 | NCT05394298 | Jul 2022 → Jul 2024 | Enterococcus infectious disease | Andalusian Public Foundation for Health Research in Seville | Unknown | No outcome recorded |
| Phase 4 | NCT05156437 | Mar 2022 → Oct 2024 | endocarditis | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT03867136 | Jun 2020 → Aug 2024 | multidrug-resistant tuberculosis | Huashan Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03830671 | Mar 2019 → Jun 2022 | multidrug-resistant tuberculosis | Beijing Chest Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03012360 | Feb 2018 → Jul 2024 | — | University Hospital, Lille | Terminated | No outcome recorded |
| Phase 4 | NCT03220074 | Dec 2017 → Jun 2021 | mycobacterial infectious disease | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT03237182 | Jun 2017 → Dec 2022 | multidrug-resistant tuberculosis | Centre for the AIDS Programme of Research in South Africa | Terminated | No outcome recorded |
| Phase 4 | NCT01805284 | Feb 2013 → Sep 2016 | pneumonia | University Ghent | Completed | No outcome recorded |
| Phase 4 | NCT01592032 | May 2012 → Jan 2015 | bacterial infectious disease, prosthesis-related infectious disease | Clinica Universidad de Navarra, Universidad de Navarra | Unknown | No outcome recorded |
| Phase 4 | NCT01200654 | Nov 2007 → Aug 2010 | methicillin-resistant staphylococcus aureus infectious disease | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 4 | NCT00087490 | Oct 2004 → Jul 2007 | methicillin-resistant staphylococcus aureus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00084266 | Oct 2004 → Mar 2010 | methicillin-resistant staphylococcus aureus infectious disease | Pfizer | Completed | Met primary |
| Phase 4 | NCT00147511 | Jun 2003 → Jun 2005 | connective tissue disorder, gram-positive bacterial infections | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00572559 | Nov 2002 → Jan 2005 | — | Pfizer | Completed | Missed primary |
| Phase not applicable9 trials | ||||||
| — | NCT06958835 | Oct 2025 → Oct 2028 expected | staphylococcus aureus infection | University Hospital, Basel, Switzerland | Recruiting | No outcome recorded |
| — | NCT07126639 | Sep 2025 → Sep 2027 expected | — | Wuhan Pulmonary Hospital | Not yet recruiting | No outcome recorded |
| — | NCT04717908 | Jan 2021 → Jun 2024 | multidrug-resistant tuberculosis | Huashan Hospital | Completed | No outcome recorded |
| — | NCT04545788 | Aug 2020 → Dec 2022 | tuberculosis | Beijing Chest Hospital | Unknown | No outcome recorded |
| — | NCT04531332 | Nov 2019 → Sep 2021 | pneumonia | October 6 University | Unknown | No outcome recorded |
| — | NCT03604848 | Aug 2018 → Aug 2024 | multidrug-resistant tuberculosis | Huashan Hospital | Unknown | No outcome recorded |
| — | NCT02778828 | Nov 2015 → Dec 2017 | tuberculosis | Fondation Hôpital Saint-Joseph | Completed | No outcome recorded |
| — | NCT02087566 | Oct 2013 → Jan 2014 | impaired renal function disease, kidney failure | Damanhour University | Completed | No outcome recorded |
| — | NCT00501150 | Sep 2005 → Jun 2007 | gram-positive bacterial infections, staphylococcal infection | Imperial College London | Completed | No outcome recorded |
| Comparator or background therapy76 trials | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| 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 1/2 | 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 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 | NCT03723551 Comparator | Feb 2019 → Apr 2025 | bacterial infectious disease | Debiopharm International SA | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03747497 Comparator | Nov 2018 → Mar 2019 | gram-positive bacterial infections, skin disease caused by bacterial infection | MicuRx | Completed | Met primary |
| 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 Stop: Business |
| Phase 2 | NCT02426918 Comparator | May 2015 → Aug 2016 | bacterial infectious disease | Debiopharm International SA | Completed | Met primary |
| 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 Stop: Enrollment |
| 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 | Met primary |
| Phase 2 | NCT01570192 Background | Sep 2010 → Apr 2015 | bacterial pneumonia | University of Florida | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Mixed |
| Phase 2/3 | NCT05293132 Background | Feb 2022 → Jun 2023 | infectious disease with sepsis | Ain Shams University | Completed | Met primary |
| 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 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT03032380 Background | Oct 2017 → Feb 2019 | lung disorder | Shionogi | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02493764 Background | Nov 2015 → Apr 2019 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02378480 Comparator | Jun 2015 → Apr 2016 | bacterial infectious disease | Paratek Pharmaceuticals Inc | Completed | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01431339 Comparator | Jul 2011 → Nov 2012 | abscess, cellulitis, skin infection | Durata Therapeutics Inc., an affiliate of Allergan plc | Completed | Met primary |
| Phase 3 | NCT01339091 Comparator | Mar 2011 → Sep 2012 | abscess, cellulitis, skin infection | Durata Therapeutics Inc., an affiliate of Allergan plc | Completed | Met primary |
| Phase 3 | NCT01170221 Comparator | Aug 2010 → Sep 2011 | skin disease caused by bacterial infection | Merck & Co., Inc. | Completed | Met primary |
| 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 | Missed primary |
| Phase 3 | NCT00326287 Comparator | Jun 2006 → Jul 2007 | pneumonia | Basilea Pharmaceutica | Completed | Met primary |
| 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 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 | Met primary |
| 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 | Met primary |
| Phase 4 | NCT02123628 Comparator | Jun 2007 → Jun 2010 | diabetes mellitus | Tourcoing Hospital | Completed | No outcome recorded |
| — | 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 Stop: Enrollment |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-11-19 | Global Alliance for TB Drug Development | Results Phase 2 Clinical Trial Results Show Potential to Shorten TB Treatment Time tballiance.org ↗
The 100 mg SPaL regimen had greater activity against TB than the standard of care HRZE (isoniazid, rifampin, pyrazinamide, and ethambutol), indicating the potential to shorten treatment time for active TB. |
| 2024-05-03 | Basilea Pharmaceutica | Results Basilea reports presentation of new data for ceftobiprole (Zevtera®) at ESCMID Global 2024 basilea.com ↗
Using the FDA-CABP-2020 primary endpoint of early clinical success at day 3 after study start, this re-analysis supported the non-inferiority of ceftobiprole to ceftriaxone ± linezolid. |
| 2019-06-06 | Global Alliance for TB Drug Development | Regulatory FDA Advisory Committee Votes Favorably on the Question of the Effectiveness and Safety of Pretomanid in Combination with Bedaquiline and Linezolid for Treatment of Highly Drug-Resistant Forms of Tuberculosis tballiance.org ↗ |
| 2019-06-05 | Upsher-Smith Laboratories | Regulatory MHLW Approves Additional Indication for LINEZOLID Injection and Tablets upsher-smith.com ↗
Osaka, Japan – June 5, 2019 – Sawai Pharmaceutical Co., Ltd. (Head office: Osaka, Japan, President: Mitsuo Sawai) today received approval of partial change applications by the Ministry of Health, Labour and Welfare (MHLW) for LINEZOLID Injection 600 mg [SAWAI] and Tablets 600 mg [SAWAI]*. |
| 2016-08-24 | Lupin Limited | Regulatory Lupin Receives FDA Approval for Generic Zyvox® Tablets lupin.com ↗ |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-19 | Global Alliance for TB Drug Development | Phase 2 Clinical Trial Results Show Potential to Shorten TB Treatment Time tballiance.org ↗ |
| 2024-05-03 | Basilea Pharmaceutica | Basilea reports presentation of new data for ceftobiprole (Zevtera®) at ESCMID Global 2024 basilea.com ↗ |
| 2019-06-06 | Global Alliance for TB Drug Development | FDA Advisory Committee Votes Favorably on the Question of the Effectiveness and Safety of Pretomanid in Combination with Bedaquiline and Linezolid for Treatment of Highly Drug-Resistant Forms of Tuberculosis tballiance.org ↗ |
| 2019-06-05 | Upsher-Smith Laboratories | MHLW Approves Additional Indication for LINEZOLID Injection and Tablets upsher-smith.com ↗ |
| 2016-08-24 | Lupin Limited | Lupin Receives FDA Approval for Generic Zyvox® Tablets lupin.com ↗ |
| 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. 179 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Linezolid | “This two-stage study will compare consented research participants with tuberculous meningitis receiving experimental Bedaquiline (B), Pretomanid (Pa), Linezolid (L);...” NCT07227779 ↗173“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 ↗ “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 ↗ |
| 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 202215“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 ↗ |
| 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 ↗ |