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linezolid

Trade name: zyvox

Small moleculeapproved

Approved

Apr 18, 2000

Linezolid is an antibiotic used for the treatment of infections caused by Gram-positive bacteria that are resistant to other antibiotics. Linezolid appears to be unique in that it blocks the initiation of protein production. Most common adverse reactions include diarrhea, vomiting, headache, nausea, and anemia. Linezolid has the potential for interaction with adrenergic and serotonergic agents. And with monoamine oxidase inhibitors because it’s nonselective inhibitor of monoamine oxidase. — NCATS

Clinical trial activity

147 trials · 203 clinical orgs · 30 marketing orgs

Phase 1
16
Phase 2
93
Phase 3
61
Phase 4
19

Earliest trial started Nov 1, 2001 (NCT00035425)

Timeline

2000s

  1. Apr 18, 2000

    Earliest FDA Approval

  2. Apr 18, 2000

    Pharmacia & Upjohn — NDA Secondary Org

  3. Apr 18, 2000

    Pfizer — Marketing Organization

  4. Apr 18, 2000

    Pfizer — NDA Secondary Org

  5. Jan 1, 2001

    Pfizer — Earliest Phase 3 Sponsor(trial)

  6. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  7. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jun 27, 2012

    Teva — Marketing Organization

  2. Jun 3, 2015

    West-Ward Pharmaceutical — Marketing Organization

  3. Jun 3, 2015

    Hikma — Marketing Organization

  4. Jun 18, 2015

    Hospira — NDA Secondary Org

  5. Jun 18, 2015

    Hospira — Marketing Organization

  6. Jul 16, 2015

    Sandoz — Marketing Organization

  7. Jul 16, 2015

    Novartis — Marketing Organization

  8. Dec 21, 2015

    Alembic — Marketing Organization

  9. Dec 21, 2015

    Alkem Labs Ltd — Marketing Organization

  10. Dec 21, 2015

    Amneal Pharmaceuticals — Marketing Organization

  11. Dec 21, 2015

    Glenmark Pharmaceuticals — Marketing Organization

  12. Dec 21, 2015

    Hetero Labs Ltd — Marketing Organization

  13. Dec 21, 2015

    Rising Pharmaceuticals — Marketing Organization

  14. Mar 15, 2016

    Fresenius — Marketing Organization

  15. Aug 4, 2016

    Aurobindo Pharma — Marketing Organization

  16. Aug 4, 2016

    Eugia Pharma — Marketing Organization

  17. Aug 22, 2016

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  18. Dec 20, 2016

    Nang Kuang Pharmaceutical Co., Ltd. — Marketing Organization

  19. Feb 22, 2017

    Zydus Discovery DMCC — Marketing Organization

  20. Mar 2, 2017

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  21. Mar 2, 2017

    Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization

  22. Jul 7, 2017

    Hq Speciality Pharma — Marketing Organization

  23. Dec 6, 2017

    Mylan — Marketing Organization

  24. Dec 6, 2017

    PHARMOBEDIENT — Marketing Organization

  25. Apr 25, 2019

    Celltrion — Marketing Organization

  26. Apr 25, 2019

    Chartwell Pharmaceuticals — Marketing Organization

2020s

  1. Oct 10, 2024

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  2. Dec 8, 2025

    Caplin Point Laboratories — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewApr 18, 2000

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)NC[C@H]1CN(C(=O)O1)C2=CC=C(N3CCOCC3)C(F)=C2
Mol. weight
337.3461 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • linezolid
  • linezolid
  • linezolid
  • linezolid
  • linezolid
  • linezolid
  • linezolid
  • linezolid
  • linezolid
  • linezolid
  • linezolid
  • linezolide
  • linezolide
  • linezolide
  • linezolid sodium chloride
  • linezolidum
  • linezolidum
  • linospan
  • linox
  • n-(((s)-3-(3-fluoro-4-morpholinophenyl)-2-oxo-5-oxazolidinyl)methyl)acetamide
  • n-(((s)-3-(3-fluoro-4-morpholinophenyl)-2-oxo-5-oxazolidinyl)methyl)acetamide
  • u 100766
  • u-100766
  • u-100766
  • u-100766
  • zyvox
  • zyvox
  • zyvox
  • zyvox
  • zyvox
  • zyvoxid

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07227779Phase 2Feb 15, 2026Makerere University, University of Minnesota
NCT07301294Phase 4Jan 1, 2026Menoufia University
NCT07138521Phase 4Oct 15, 2025Alexandria University
NCT06958835N/AOct 6, 2025Swiss National Science Foundation, University of Basel
NCT06921213Phase 2Oct 1, 2025Chiangmai University, Medical Research Council, Murdoch University, National University of Ireland, Stellenbosch University, University of London, University of Sydney, Wellcome Trust
NCT07198685N/ASep 30, 2025Huazhong University of Science and Technology
NCT07126639N/ASep 1, 2025Huazhong University of Science and Technology
NCT07076225Phase 3Jul 25, 2025Capital Medical University, Fudan University, Huazhong University of Science and Technology, Shenzhen Third People's Hospital, Sichuan University, Tsinghua University
NCT06905522Phase 3Apr 15, 2025Shenyang Tenth People's Hospital, Shenzhen Third People's Hospital, Zhejiang University
NCT06590428N/ANov 30, 2024Columbia University, Emory University, National Institute of Allergy and Infectious Diseases (NIAID), University of Cape Town, University of London, Yeshiva University
NCT06649721Phase 3Nov 15, 2024Capital Medical University, Fudan University
NCT06441006Phase 3Nov 1, 2024Johns Hopkins University, University of California, San Francisco
NCT06192160Phase 2Oct 15, 2024National Institute of Allergy and Infectious Diseases (NIAID), TB Alliance, University of California, Berkeley, Vanderbilt University
NCT06444802Phase 3Sep 1, 2024University of Hamburg
NCT06336824Phase 3Jun 28, 2024Clinical Research Centre, Malaysia, Government of Malaysia
NCT06811025Phase 1/Phase 2 (Phase 2)Feb 1, 2024Capital Medical University
NCT06811012Phase 1/Phase 2 (Phase 2)Jan 31, 2024Capital Medical University
NCT06114628Phase 2Dec 8, 2023German Center for Infection Research, GlaxoSmithKline, Government of France, Janssen Pharmaceutica NV, KNCV Tuberculosis Foundation, Otsuka, Radboud University, Research Center Borstel, TASK Applied Science, TB Alliance, Tuberculosis Network European Trialsgroup, University of California, San Francisco, University of Cambridge, University of Hamburg, University of Liverpool, University of London, University of Milan, University of Oxford, University of Porto, University of St Andrews, Uppsala University, Vita-Salute University of Milano. Italy
NCT06081361Phase 3Nov 1, 2023Capital Medical University
NCT06058299Phase 2Oct 31, 2023Global Alliance for TB Drug Development, TB Alliance
Showing 20 of 147 trials
Page 1 / 8

Organizations

Research & Development (203)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit201452001
University of LondonAcademic/Hospital11432005
Capital Medical UniversityAcademic/Hospital8642019
National Institute of Allergy and Infectious Diseases (NIAID)Government8642003
Global Alliance for TB Drug DevelopmentAcademic/Hospital7422014
Medecins Sans FrontieresAcademic/Hospital6612016
University of California, San FranciscoAcademic/Hospital6222019
University of Cape TownAcademic/Hospital6232009
Boston UniversityAcademic/Hospital5232003
Fudan UniversityAcademic/Hospital5422019
MerckFor profit5212014
Paratek Pharmaceuticals IncFor profit5522007
AllerganFor profit4322011
GlaxoSmithKlineFor profit4232009
University of UlsanAcademic/Hospital4132012
Basilea PharmaceuticaFor profit3312005
Cempra IncFor profit3322009
Columbia UniversityAcademic/Hospital3022009
Forest LaboratoriesFor profit3322008
Government of BelarusGovernment3012017
203 organizations
Page 1 / 11

Marketing (42)

OrganizationOrg typeRelationshipDate
AlembicFor profitMKTGDec 21, 2015
AlembicFor profitSYNDec 21, 2015
Alkem Labs LtdFor profitMKTGDec 21, 2015
Amneal PharmaceuticalsFor profitMKTGDec 21, 2015
Aurobindo PharmaFor profitMKTGAug 4, 2016
Caplin Point LaboratoriesFor profitMKTGDec 8, 2025
CelltrionFor profitMKTGApr 25, 2019
Chartwell PharmaceuticalsFor profitMKTGApr 25, 2019
Eugia PharmaFor profitMKTGAug 4, 2016
FreseniusFor profitMKTGMar 15, 2016
Glenmark PharmaceuticalsFor profitSYNDec 21, 2015
Glenmark PharmaceuticalsFor profitMKTGDec 21, 2015
Hetero Labs LtdFor profitMKTGDec 21, 2015
Hetero Labs LtdFor profitSYNOct 31, 2022
HikmaFor profitMKTGJun 3, 2015
HikmaFor profitSYNJun 3, 2015
HospiraFor profitNDA2Jun 18, 2015
HospiraFor profitMKTGJun 18, 2015
Hq Speciality PharmaFor profitMKTGJul 7, 2017
Macleods Pharmaceuticals, LtdFor profitMKTGOct 10, 2024
MylanFor profitSYNDec 21, 2015
MylanFor profitMKTGDec 6, 2017
MylanFor profitSYNDec 21, 2015
Nang Kuang Pharmaceutical Co., Ltd.For profitMKTGDec 20, 2016
Nichi-Iko Pharmaceutical Co., Ltd.For profitMKTGMar 2, 2017
NovartisFor profitMKTGJul 16, 2015
Novel Anti-Infective Technologies, LLCFor profitMKTGAug 22, 2016
PHARMOBEDIENTFor profitMKTGDec 6, 2017
PfizerFor profitMKTGApr 18, 2000
PfizerFor profitNDA2Apr 18, 2000
PharmaciaFor profitNDA—
Pharmacia & UpjohnFor profitNDA2Apr 18, 2000
Rising PharmaceuticalsFor profitMKTGDec 21, 2015
Sagent Pharmaceuticals, Inc.For profitSYNMar 2, 2017
Sagent Pharmaceuticals, Inc.For profitMKTGMar 2, 2017
SandozFor profitMKTGJul 16, 2015
SandozFor profitSYNJul 16, 2015
TevaFor profitSYNFeb 5, 2016
TevaFor profitMKTGJun 27, 2012
TevaFor profitSYNMay 18, 2015
West-Ward PharmaceuticalFor profitMKTGJun 3, 2015
Zydus Discovery DMCCFor profitMKTGFeb 22, 2017