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isoniazid

Trade name: nydrazid

Small moleculeapproved

Approved

Jun 1, 1952

Isoniazid is a bactericidal agent active against organisms of the genus Mycobacterium, specifically M. tuberculosis, M. bovis and M. kansasii. Isoniazid is recommended for all forms of tuberculosis in which organisms are susceptible. Isoniazid is a prodrug and must be activated by bacterial catalase. Isoniazid inhibits InhA, the enoyl reductase from Mycobacterium tuberculosis, by forming a covalent adduct with the NAD cofactor. The most frequent adverse reactions to isoniazid are those affecting the nervous system and the liver. — NCATS

Clinical trial activity

208 trials · 299 clinical orgs · 35 marketing orgs

Phase 1
29
Phase 2
105
Phase 3
61
Phase 4
38

Earliest trial started Jan 1, 1994 (NCT00402610)

Timeline

1950s

  1. Jun 1, 1952

    Earliest FDA Approval

  2. Sep 29, 1952

    Sandoz — First NDA Organization

  3. Sep 29, 1952

    Sandoz — NDA Secondary Org

  4. Sep 29, 1952

    Sandoz — NDA Organization

  5. Nov 17, 1952

    Epic Pharma Llc — Marketing Organization

  6. Nov 17, 1952

    Epic Pharma Llc — NDA Secondary Org

1970s

  1. Nov 13, 1970

    Sun Pharmaceuticals — Marketing Organization

  2. Apr 14, 1971

    Whiteworth Towne Paulsen — Marketing Organization

  3. Nov 4, 1971

    Dow Pharmaceutical Sciences — Marketing Organization

  4. Jan 21, 1972

    Everylife Foundation for Rare Diseases — Marketing Organization

  5. Feb 3, 1972

    Watson Pharmaceuticals — Marketing Organization

  6. Feb 28, 1972

    Hikma — Marketing Organization

  7. Mar 16, 1972

    MK Labs — Marketing Organization

  8. Aug 24, 1972

    Barr Laboratories — Marketing Organization

  9. Jun 11, 1973

    Panray Corp. — NDA Secondary Org

  10. Aug 1, 1973

    Impax Laboratories — Marketing Organization

  11. Jan 15, 1974

    Teva — Marketing Organization

  12. Oct 22, 1974

    Nexgen Pharma, Inc — Marketing Organization

  13. Jul 11, 1975

    Sanofi-Aventis — Marketing Organization

  14. Aug 29, 1975

    Lannett Company, Inc. — Marketing Organization

  15. Dec 18, 1975

    Phoenix Laboratories — Marketing Organization

  16. Jul 29, 1976

    Pharmavite — Marketing Organization

1980s

  1. Mar 4, 1982

    Puracap Pharmaceutical — Marketing Organization

  2. Mar 17, 1983

    Duramed Research — Marketing Organization

  3. Nov 10, 1983

    CMP Therapeutics Ltd — Marketing Organization

1990s

  1. May 31, 1994

    Sanofi-Aventis — NDA Secondary Org

  2. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

  3. Jun 26, 1997

    Mikart — Marketing Organization

  4. Jun 26, 1997

    ANDA Repository — Marketing Organization

  5. Jun 26, 1997

    Genus Oncology, LLC — Marketing Organization

  6. Jun 26, 1997

    OMNIVIUM PHARMS — Marketing Organization

  7. Jul 21, 1997

    Chartwell Pharmaceuticals — Marketing Organization

  8. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

  9. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jul 5, 2005

    Sandoz — Marketing Organization

  2. Jul 5, 2005

    Novartis — Marketing Organization

2010s

  1. Oct 29, 2014

    Thepharmanetwork Llc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJun 1, 1952

Chemistry & pharmacology

Loading structure…

SMILES

NNC(=O)C1=CC=NC=C1
Mol. weight
137.1393 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 4-pyridinecarbohydrazide
  • 4-pyridinecarbohydrazide
  • 4-pyridinecarboxylic hydrazide
  • armazid
  • dow-isoniazid
  • dow-isoniazid
  • hyzyd
  • hyzyd
  • inh
  • inh
  • inh
  • isoniazid
  • isoniazid
  • isoniazid
  • isoniazid
  • isoniazid
  • isoniazid
  • isoniazid
  • isoniazid
  • isoniazid
  • isoniazid
  • isoniazid
  • isoniazide
  • isoniazide
  • isoniazide
  • isonicotinic acid hydrazide
  • isonicotinic acid hydrazide
  • isonicotinic acid hydrazide
  • isonicotinic hydrazide
  • isonicotinic hydrazide
  • isonicotinohydrazide
  • isonicotinohydrazide
  • isonicotinohydrazide
  • isonicotinoylhydrazide
  • isonicotinoylhydrazide
  • isonicotinsaeurehydrazid
  • isonicotinsaeurehydrazid
  • isonicotinylhydrazine
  • isonicotinylhydrazine
  • isonicotinylhydrazine
  • laniazid
  • laniazid
  • nicotibine
  • nicotibine
  • nydrazid
  • nydrazid
  • nydrazid
  • nydrazid
  • pyridine-4-carboxylic acid hydrazide
  • pyridine-4-carboxylic acid hydrazide
  • rimifon
  • rimifon
  • stanozide
  • stanozide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07303699Phase 2Jan 3, 2026Obafemi Awolowo University, Open Philanthropy Project
NCT07124559Phase 1/Phase 2 (Phase 2)Dec 15, 2025National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
NCT07163143Phase 3Nov 30, 2025Aurum Institute, Foundation for Innovative New Diagnostics, Switzerland, KTH Royal Institute of Technology, University of London, Wits Health Consortium (Pty) Ltd
NCT07086820N/AOct 31, 2025Pontificia Universidad Catolica de Chile
NCT07073638Phase 2Oct 6, 202530 Technology
NCT07069582Phase 1Oct 1, 2025McGill University, Padjadjaran University
NCT07129629Phase 2Aug 20, 2025Fudan University, Huazhong University of Science and Technology
NCT07058090Phase 1Jul 31, 2025Liaquat University of Medical & Health Sciences
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
NCT06917495Phase 2Apr 5, 2025Shandong University
NCT06568484Phase 3Nov 30, 2024Elizabeth Glaser Pediatric AIDS Foundation, Johns Hopkins University, United States Agency for International Development
NCT06253715Phase 3Nov 27, 2024Johns Hopkins University, United States Agency for International Development
NCT06192160Phase 2Oct 15, 2024National Institute of Allergy and Infectious Diseases (NIAID), TB Alliance, University of California, Berkeley, Vanderbilt University
NCT06611813Phase 2Jun 11, 2024Zhejiang University
NCT06191692Phase 3Apr 1, 2024Freundeskreis Für Internationale Tuberkulosehilfe e.V
NCT05917340Phase 3Mar 31, 2024All India Institute of Medical Sciences, Christian Medical College, Vellore, India, Indian Council of Medical Research, Jawaharlal Institute of Postgraduate Medical Education and Research, Madras Medical College, National Institute for Research in Tuberculosis, Chennai, India
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
NCT06058299Phase 2Oct 31, 2023Global Alliance for TB Drug Development, TB Alliance
NCT06041919Phase 2Sep 27, 202330 Technology
Showing 20 of 208 trials
Page 1 / 11

Organizations

Research & Development (299)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government372851999
Johns Hopkins UniversityAcademic/Hospital26851995
Centers for Disease Control and Prevention (CDC)Government181551995
University of Cape TownAcademic/Hospital16742003
University of LondonAcademic/Hospital11332007
Aswan UniversityAcademic/Hospital9922020
Aurum InstituteAcademic/Hospital9432016
Fudan UniversityAcademic/Hospital9642009
Global Alliance for TB Drug DevelopmentAcademic/Hospital9622006
Department of Veteran AffairsGovernment8031995
National Institutes of Health (NIH)Government8242003
National Taiwan UniversityAcademic/Hospital8732007
Stellenbosch UniversityAcademic/Hospital8022003
TASK Applied ScienceFor profit8212014
Bill and Melinda Gates FoundationAcademic/Hospital7222005
Capital Medical UniversityAcademic/Hospital7542008
Medical Research CouncilGovernment7132003
University of California, San FranciscoAcademic/Hospital7242004
AIDS Clinical Trials GroupAcademic/Hospital6432008
Huazhong University of Science and TechnologyAcademic/Hospital6332008
299 organizations
Page 1 / 15

Marketing (41)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGJun 26, 1997
Athenex, Inc.For profitMKTG—
Barr LaboratoriesFor profitMKTGAug 24, 1972
Bristol-Myers SquibbFor profitNDA2—
CMP Therapeutics LtdFor profitMKTGNov 10, 1983
Chartwell PharmaceuticalsFor profitMKTGJul 21, 1997
Chartwell PharmaceuticalsFor profitSYNJun 13, 1988
Dow Pharmaceutical SciencesFor profitMKTGNov 4, 1971
Duramed ResearchFor profitMKTGMar 17, 1983
Eli LillyFor profitNDA2—
Epic Pharma LlcFor profitMKTGNov 17, 1952
Epic Pharma LlcFor profitNDA2Nov 17, 1952
Everylife Foundation for Rare DiseasesAcademic/HospitalMKTGJan 21, 1972
Genus Oncology, LLCFor profitMKTGJun 26, 1997
Genus Oncology, LLCFor profitSYNAug 24, 1972
HalseyFor profitMKTG—
HikmaFor profitMKTGFeb 28, 1972
Impax LaboratoriesFor profitMKTGAug 1, 1973
Lannett Company, Inc.For profitMKTGAug 29, 1975
MK LabsFor profitMKTGMar 16, 1972
MedpointeFor profitMKTG—
MikartFor profitMKTGJun 26, 1997
Nexgen Pharma, IncFor profitMKTGOct 22, 1974
NovartisFor profitMKTGJul 5, 2005
OMNIVIUM PHARMSFor profitMKTGJun 26, 1997
Panray Corp.For profitNDA2Jun 11, 1973
PerrigoFor profitMKTG—
PharmaviteFor profitMKTGJul 29, 1976
Phoenix LaboratoriesFor profitMKTGDec 18, 1975
Puracap PharmaceuticalFor profitMKTGMar 4, 1982
RocheFor profitNDA2—
SandozFor profitNDA2Sep 29, 1952
SandozFor profitMKTGJul 5, 2005
SandozFor profitNDASep 29, 1952
Sanofi-AventisFor profitMKTGJul 11, 1975
Sanofi-AventisFor profitNDA2May 31, 1994
Sun PharmaceuticalsFor profitMKTGNov 13, 1970
TevaFor profitMKTGJan 15, 1974
Thepharmanetwork LlcFor profitMKTGOct 29, 2014
Watson PharmaceuticalsFor profitMKTGFeb 3, 1972
Whiteworth Towne PaulsenFor profitMKTGApr 14, 1971