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pyridoxine

Small moleculeapproved

Approved

Jul 28, 1947

Pyridoxine is the 4-methanol form of vitamin B6 and is converted to pyridoxal 5-phosphate in the body. Vitamin B6 (pyridoxine) is a water-soluble vitamin used in the prophylaxis and treatment of vitamin B6 deficiency and peripheral neuropathy in those receiving isoniazid (isonicotinic acid hydrazide, INH). Vitamin B6 has been found to lower systolic and diastolic blood pressure in a small group of subjects with essential hypertension. Hypertension is another risk factor for atherosclerosis and coronary heart disease. Another study showed pyridoxine hydrochloride to inhibit ADP- or epinephrine-induced platelet aggregation and to lower total cholesterol levels and increase HDL-cholesterol levels, again in a small group of subjects. Vitamin B6, in the form of pyridoxal 5'-phosphate, was found to protect vascular endothelial cells in culture from injury by activated platelets. Endothelial injury and dysfunction are critical initiating events in the pathogenesis of atherosclerosis. Human studies have demonstrated that vitamin B6 deficiency affects cellular and humoral responses of the immune system. Vitamin B6 deficiency results in altered lymphocyte differentiation and maturation, reduced delayed-type hypersensitivity (DTH) responses, impaired antibody production, decreased lymphocyte proliferation and decreased interleukin (IL)-2 production, among other immunologic activities. Used for the treatment of vitamin B6 deficiency and for the prophylaxis of isoniazid-induced peripheral neuropathy. — NCATS

Clinical trial activity

157 trials · 202 clinical orgs · 29 marketing orgs

Phase 1
18
Phase 2
69
Phase 3
41
Phase 4
16

Earliest trial started May 1, 1993 (NCT00000541)

Timeline

1940s

  1. Jul 28, 1947

    Earliest FDA Approval

  2. Jul 28, 1947

    Roche — Marketing Organization

1950s

  1. Feb 20, 1953

    Hospira — Marketing Organization

  2. Feb 20, 1953

    Hospira — NDA Secondary Org

  3. Jul 30, 1956

    Sanofi-Aventis — Marketing Organization

  4. Jul 30, 1956

    Sanofi-Aventis — NDA Secondary Org

1970s

  1. Aug 14, 1972

    Fresenius — Marketing Organization

  2. Jun 22, 1973

    Eli Lilly — Marketing Organization

  3. Dec 11, 1973

    Belmar Pharmacy — Marketing Organization

  4. Feb 13, 1974

    Watson Pharmaceuticals — Marketing Organization

  5. Feb 13, 1974

    Dr. Reddy's Laboratories — Marketing Organization

  6. Mar 18, 1975

    Del Laboratories — Marketing Organization

1980s

  1. Nov 6, 1981

    Abraxis — Marketing Organization

  2. Nov 6, 1981

    Abraxis — NDA Secondary Org

  3. Jul 13, 1982

    Watson Pharmaceuticals — NDA Secondary Org

  4. Mar 9, 1983

    Elkins Sinn — Marketing Organization

1990s

  1. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. May 18, 2000

    Sandoz — Marketing Organization

  2. May 18, 2000

    Sandoz — NDA Secondary Org

  3. May 18, 2000

    Novartis — NDA Secondary Org

2010s

  1. Apr 8, 2013

    Duchesnay Inc. — Marketing Organization

  2. Apr 8, 2013

    Duchesnay Inc. — NDA Secondary Org

  3. Jul 14, 2016

    Mylan — Marketing Organization

  4. Aug 19, 2016

    Actavis — Marketing Organization

  5. Aug 19, 2016

    Allergan PLC (2015) — Marketing Organization

  6. Dec 6, 2017

    Par Pharmaceuticals — Marketing Organization

  7. Dec 6, 2017

    Bristol-Myers Squibb — Marketing Organization

  8. Dec 6, 2017

    Endo Pharmaceuticals — Marketing Organization

  9. Dec 6, 2017

    PH HEALTH — Marketing Organization

2020s

  1. Jul 6, 2020

    PHARMOBEDIENT — Marketing Organization

  2. Mar 1, 2022

    AbbVie — Marketing Organization

  3. Aug 4, 2023

    Bionpharma Inc — Marketing Organization

  4. Apr 9, 2026

    Apotex — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJul 28, 1947

Chemistry & pharmacology

Loading structure…

SMILES

Cc1ncc(COP(=O)(O)O)c(C=O)c1O.O
Mol. weight
265.16 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 2-methyl-3-hydroxy-4,5-dihydroxymethylpyridine
  • 2-methyl-3-hydroxy-4,5-dihydroxymethylpyridine
  • 3-hydroxy-2-methyl-5-((phosphonooxy)methyl)-4-pyridinecarboxaldehyde
  • 3-hydroxy-2-methyl-5-((phosphonooxy)methyl)-4-pyridinecarboxaldehyde
  • 3-hydroxy-4,5-bis(hydroxymethyl)-2-methylpyridine
  • 3-hydroxy-4,5-bis(hydroxymethyl)-2-methylpyridine
  • 3-hydroxy-4,5-dimethylol-alpha-picoline
  • 3-hydroxy-4,5-dimethylol-alpha-picoline
  • 3-hydroxy-5-(hydroxymethyl)-2-methylisonicotinaldehyde 5-phosphate
  • 3-hydroxy-5-(hydroxymethyl)-2-methylisonicotinaldehyde 5-phosphate
  • 5-hydroxy-6-methyl-3,4-pyridinedimethanol
  • 5-hydroxy-6-methyl-3,4-pyridinedimethanol
  • adermin
  • beesix
  • beesix
  • benadon
  • benadon
  • bendectin
  • bezatin
  • bonifen
  • codecarboxylase
  • codecarboxylase
  • codecarboxylase
  • coenzyme b6
  • comploment continus
  • debendox
  • diclectin
  • diclectin
  • diclectin
  • diclegis
  • diclegis
  • diclegis
  • diclegis
  • dicyclomine - doxylamine - pyridoxine
  • dicyclomine, doxylamine, pyridoxine drug combination
  • dipyridoxolyl disulfide
  • doxylamine, pyridoxine drug combination
  • doxylamine succinate - pyridoxine hydrochloride
  • doxylamine succinate, pyridoxine hydrochloride drug combination
  • encefabol
  • hexa-betalin
  • hexa-betalin
  • kent b6
  • lyphomed
  • metadoxil
  • metadoxine
  • metadoxine
  • metadoxine
  • metadoxyl
  • m.v.i.-12
  • orovite comploment b6
  • phosphopyridoxal
  • phosphopyridoxal coenzyme
  • piritinol
  • pirivitol
  • plp
  • plp
  • pyrid-10
  • pyrid-20
  • pyridoxal 5-monophosphoric acid ester
  • pyridoxal 5-monophosphoric acid ester
  • pyridoxal 5-monophosphoric acid ester
  • pyridoxal-5p
  • pyridoxal-5p
  • pyridoxal 5-phosphate
  • pyridoxal 5-phosphate
  • pyridoxal 5-phosphate
  • pyridoxal 5-phosphate
  • pyridoxal 5-phosphate
  • pyridoxal 5'-phosphate
  • pyridoxal 5'-phosphate
  • pyridoxal 5'-phosphate
  • pyridoxal-5'-phosphate
  • pyridoxal-5'-phosphate
  • pyridoxaldehyde phosphate
  • pyridoxal monophosphate
  • pyridoxal p
  • pyridoxal p
  • pyridoxal-p
  • pyridoxal-p
  • pyridoxal phosphate
  • pyridoxal phosphate
  • pyridoxal phosphate
  • pyridoxal phosphate
  • pyridoxal phosphate
  • pyridoxal phosphate anhydrous
  • pyridoxal phosphate anhydrous
  • pyridox hcl
  • pyridoxin
  • pyridoxine
  • pyridoxine
  • pyridoxine
  • pyridoxine
  • pyridoxine
  • pyridoxine
  • pyridoxine
  • pyridoxine
  • pyridoxine
  • pyridoxine
  • pyridoxine
  • pyridoxine disulfide
  • pyridoxine hcl
  • pyridoxine hcl
  • pyridoxine hcl
  • pyridoxine hydrochloride
  • pyridoxine hydrochloride
  • pyridoxine hydrochloride
  • pyridoxine hydrochloride
  • pyridoxine hydrochloride
  • pyridoxine (vit b6)
  • pyridoxine (vit b6)
  • pyridoxine (vit b6)
  • pyridoxol
  • pyridoxol
  • pyridoxol hcl
  • pyridox-roche
  • pyridoxyl phosphate
  • pyrithioxin
  • pyrithioxine
  • pyrithioxine
  • pyrithioxine hcl
  • pyrithioxine hcl
  • pyritinol
  • pyritinol
  • pyritinol
  • pyritinol
  • pyritinol
  • pyritinol
  • vital foods
  • vitalife
  • vitamin b6
  • vitamin b6
  • vitamin b6
  • vitamin b6
  • vitamin b6
  • vitamin b6
  • vitamin b6 (active form)
  • vitamin b6 disulfide
  • vitamin b6 phosphate
  • vitamins b6

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07305519N/AJan 1, 2026University of Roma La Sapienza
NCT06369350Early Phase 1 (Phase 1)Dec 31, 2025American Heart Association, Pennsylvania State University
NCT07271966N/ADec 15, 2025Duke University
NCT07257497Phase 1Dec 9, 2025Sichuan University
NCT07029698Phase 4Apr 16, 2025Medice Arzneimittel Pütter GmbH & Co KG
NCT06749756N/ADec 15, 2024University of Electronic Science and Technology of China
NCT06625632N/AOct 7, 2024Cairo University
NCT06445933N/AJul 5, 2024Chang Gung University, National Taiwan University
NCT06386211Phase 1Jul 3, 2024Sanofi
NCT06512441N/AJun 1, 2024Changhai Hospital, University of Science and Technology of China
NCT06415383Phase 1May 31, 2024INNOPURE, University of Reading
NCT06772220N/AMar 5, 2024Oregon Health and Science University
NCT06342778Phase 1Feb 27, 2024Valenta Pharm JSC
NCT06234501N/AJan 31, 2024INNOPURE, University of Reading
NCT06390787Phase 2/Phase 3 (Phase 3)Jan 30, 2024University of Baghdad
NCT07304453Phase 2Jan 7, 2024Karbala University, Kufa University
NCT05837104Phase 2Dec 13, 2023Mclean Hospital
NCT06152991Phase 3Sep 25, 2023Seoul National University
NCT06020300Phase 4Jul 28, 2023National University of Malaysia
NCT06244121N/AJun 3, 2023Bangladesh Medical University
Showing 20 of 157 trials
Page 1 / 8

Organizations

Research & Development (202)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government161441999
Alcobra Ltd.For profit8832009
University of Texas at HoustonAcademic/Hospital7612004
University of TorontoAcademic/Hospital6142006
Bangladesh Medical UniversityAcademic/Hospital5532016
Johns Hopkins UniversityAcademic/Hospital5032012
Technion UniversityAcademic/Hospital5032009
MedicureFor profit4422004
AIDS Clinical Trials GroupAcademic/Hospital3222013
Duchesnay Inc.For profit3222006
Duke UniversityAcademic/Hospital3122006
National Cancer Institute (NCI)Government3122004
Radboud UniversityAcademic/Hospital3221996
Rush UniversityAcademic/Hospital3222008
Taichung Veterans General HospitalAcademic/Hospital3322011
University of California, San FranciscoAcademic/Hospital3232017
University of NebraskaAcademic/Hospital3022012
Ben Gurion UniversityAcademic/Hospital2222005
Cairo UniversityAcademic/Hospital2222018
Centers for Disease Control and Prevention (CDC)Government2222013
202 organizations
Page 1 / 11

Marketing (37)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGMar 1, 2022
AbraxisFor profitMKTGNov 6, 1981
AbraxisFor profitNDA2Nov 6, 1981
ActavisFor profitMKTGAug 19, 2016
Akorn, Inc.For profitMKTG—
Allergan PLC (2015)For profitMKTGAug 19, 2016
ApotexFor profitMKTGApr 9, 2026
Belmar PharmacyFor profitMKTGDec 11, 1973
Bionpharma IncFor profitMKTGAug 4, 2023
Bristol-Myers SquibbFor profitMKTGDec 6, 2017
Del LaboratoriesFor profitMKTGMar 18, 1975
Dr. Reddy's LaboratoriesFor profitMKTGFeb 13, 1974
Duchesnay Inc.For profitMKTGApr 8, 2013
Duchesnay Inc.For profitNDA2Apr 8, 2013
Eli LillyFor profitMKTGJun 22, 1973
Elkins SinnFor profitMKTGMar 9, 1983
Endo PharmaceuticalsFor profitMKTGDec 6, 2017
FreseniusFor profitMKTGAug 14, 1972
HospiraFor profitMKTGFeb 20, 1953
HospiraFor profitNDA2Feb 20, 1953
International Minerals and Chemical CorporationFor profitNDA2—
LutipoldFor profitMKTG—
MylanFor profitMKTGJul 14, 2016
MylanFor profitSYNJul 6, 2020
NovartisFor profitNDA2May 18, 2000
PH HEALTHFor profitMKTGDec 6, 2017
PHARMOBEDIENTFor profitMKTGJul 6, 2020
Par PharmaceuticalsFor profitMKTGDec 6, 2017
RocheFor profitNDA—
RocheFor profitMKTGJul 28, 1947
SandozFor profitMKTGMay 18, 2000
SandozFor profitNDA2May 18, 2000
Sanofi-AventisFor profitMKTGJul 30, 1956
Sanofi-AventisFor profitNDA2Jul 30, 1956
Teligent PharmaceuticalsFor profitNDA2—
Watson PharmaceuticalsFor profitMKTGFeb 13, 1974
Watson PharmaceuticalsFor profitNDA2Jul 13, 1982