Drugs / Pyridoxine
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Pyridoxine

Developed for
myocardial infarction · end stage renal failure · hand-foot syndrome · hyperemesis gravidarum · hyperhomocysteinemia · hyperlipidemia · infantile spasms · infectious disease with sepsis
+42 more · schizophrenia · acute kidney injury · acute myocardial infarction · Alzheimer disease · atherosclerosis · autism spectrum disorder · bipolar I disorder · cardiomyopathy · cardiovascular disorder · carpal tunnel syndrome · cerebral infarction · cognitive disorder · congestive heart failure · coronary atherosclerosis · diabetic polyneuropathy · inflammatory bowel disease · kidney failure · mixed anxiety and depressive disorder · movement disorder · myocardial ischemia · non-small cell lung carcinoma · obesity disorder · obsessive-compulsive disorder · pernicious anemia · polycystic ovary syndrome · postpartum depression · protein-energy malnutrition · psoriasis · pulmonary embolism · stroke disorder · tardive dyskinesia · transient ischemic attack · type 2 diabetes mellitus · venous thromboembolism · vitamin B12 deficiency · autism spectrum disorder 1 · chemotherapy-induced neuropathy · coronary artery disorder · COVID-19 · ischemic disease · lactation disease · pregnancy disorder
Investigated by
BREGO Life Sciences Sdn Bhd · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Beersheva Mental Health Center · National Institute of Neurological Disorders and Stroke (NINDS) · National Institute on Aging (NIA) · Abbott
+90 more · Abbott Diagnostics Division · Affiliated Hospital of Jiamusi Medical University · Al-Rasheed University College · Alzheimer's Disease Cooperative Study (ADCS) · Asan Medical Center · Brigham and Women's Hospital · Buck Institute for Research on Aging · Canadian Institutes of Health Research (CIHR) · Casa de Saúde santa Marcelina · Centers for Disease Control and Prevention · Changhai Hospital · Colorado State University · Cook County Health · Drug Research and Development Center, Federal University of Ceara · Duchesnay Inc. · Fan Zeng · First Affiliated Hospital of Heilongjiang Chinese Medicine University · Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway · Fundação Educacional Serra dos Órgãos · Georgetown University · Grupo CINUSA (Centros de Investigación en Nutrición y Salud S.L.) · Göteborg University · Hamilton Health Sciences Corporation · Harvard School of Public Health (HSPH) · Hegang Maternal and Child Health Hospital · Heilongjiang Provicial Hospital · Hoskinson Health and Wellness Clinic · Hospital Universitario Dr. Jose E. Gonzalez · INNOPURE · International Schizophrenia Foundation · Jiamusi Maternal and Child Health Hospital · Jiangxi Maternal and Child Health Hospital · Jixi Maternal and Child Health Hospital · KEMRI-Wellcome Trust Collaborative Research Program · Kenya Medical Research Institute · Lady Hardinge Medical College · Leiner Health Products · Luoyang Hospital of TCM · MIPO Clinic · Margan Biotech · Mclean Hospital · Medice Arzneimittel Pütter GmbH & Co KG · Ministry of Health, Uganda · Mudanjaing Maternal and Child Health Hospital · National Center for Research Resources (NCRR) · National Heart, Lung, and Blood Institute (NHLBI) · National Institute for Health Research, United Kingdom · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Taiwan University Hospital · Netherlands Heart Foundation · Ningxia Hui Autonomous Region Hospital of TCM · Office of Dietary Supplements (ODS) · Pan American Laboratories · Phoenix VA Health Care System · Population Health Research Institute · Premier Research · Queen Mary University of London · Radboud University Medical Center · Sha'ar Menashe Mental Health Center · Shuangyashan Maternal and Child Health Hospital · Suihua Maternal and Child Health Hospital · Supported by a Hilton Family Foundation grant to · The Council on Health and Rehabilitation, Norway · The First People's Hospital of Huzhou · The International Federation of Red Cross and Red Crescent Societies · The Norwegian Council on Cardiovascular Disease · The Research Council of Norway · The Royal Norwegian Ministry of Health · Tirat Carmel Mental Health Center · Tropical Gastroenterology & Nutrition Group (TROPGAN) · US Department of Veterans Affairs · Unity Health Toronto · Universiti Putra Malaysia · Universiti Sains Malaysia · all 96 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) BEROCCA PN — 1947-07-28 fda.gov ↗

Trials 47

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT06242535 Jul 2023 → May 2024 cognitive disorder, depressive disorder, hyperlipidemia, hypertensive disorder +1 Hoskinson Health and Wellness Clinic Completed No outcome recorded
Phase 0 NCT03738943 Feb 2019 → Jun 2021 — Colorado State University Completed No outcome recorded
Phase 13 trials
Phase 1 NCT06415383 May 2024 → Mar 2025 — University of Reading Completed No outcome recorded
Phase 1 NCT06209229 May 2022 → May 2023 non-small cell lung carcinoma MIPO Clinic Completed No outcome recorded
Phase 1 NCT01864824 Jun 2013 → Jul 2014 — Harvard School of Public Health (HSPH) Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01704599 Jan 2009 → Jun 2013 psoriasis Wayne State University Terminated No outcome recorded
Phase 27 trials · 1 missed
Phase 2 NCT06568185 May → Oct 2024 overdue diabetic polyneuropathy Universiti Sains Malaysia Recruiting No outcome recorded
Phase 2 NCT05837104 Dec 2023 → Oct 2026 expected bipolar I disorder, mixed anxiety and depressive disorder Mclean Hospital Recruiting No outcome recorded
Phase 2 NCT03963479 Jan → Jul 2019 autism spectrum disorder Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Unknown No outcome recorded
Phase 2 NCT02773147 Apr 2016 → Nov 2018 HIV infectious disease Göteborg University Unknown No outcome recorded
Phase 2 NCT01730313 Feb 2016 → Jul 2017 — Centers for Disease Control and Prevention Withdrawn No outcome recorded
Phase 2 NCT00004758 Nov 1993 → ? infantile spasms National Center for Research Resources (NCRR) Completed No outcome recorded
Phase 2 NCT00000541 May 1993 → Jul 2005 coronary atherosclerosis, myocardial infarction, myocardial ischemia Brigham and Women's Hospital Completed Missed primary
Phase 2/34 trials · 2 missed
Phase 2/3 NCT06940557 Dec 2023 → Sep 2024 carpal tunnel syndrome Universiti Putra Malaysia Completed No outcome recorded
Phase 2/3 NCT03790345 Sep 2019 → Jun 2020 movement disorder, schizophrenia Drug Research and Development Center, Federal University of Ceara Unknown No outcome recorded
Phase 2/3 NCT00064753 May 2002 → Oct 2011 cardiovascular disorder, chronic kidney disease National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed Missed primary
Phase 2/3 NCT00114400 Nov 2000 → Feb 2007 atherosclerosis National Institute on Aging (NIA) Completed Missed primary
Phase 39 trials · 1 met primary · 4 missed
Phase 3 NCT05994742 Jul 2024 → Aug 2026 overdue HIV infectious disease, protein-energy malnutrition Queen Mary University of London Active not recruiting No outcome recorded
Phase 3 NCT04401384 Jun 2020 → Jun 2021 hyperemesis gravidarum Xiaoke Wu Completed Met primary
Phase 3 NCT01828437 Nov 2012 → Mar 2014 infantile spasms Lady Hardinge Medical College Completed Missed primary
Phase 3 NCT01908452 Jul 2011 tardive dyskinesia Beersheva Mental Health Center Withdrawn No outcome recorded Stop: Business
Phase 3 NCT00614445 Jan 2008 → Jul 2009 hyperemesis gravidarum Duchesnay Inc. Completed No outcome recorded
Phase 3 NCT00446147 Jun 2004 → Dec 2006 hand-foot syndrome Asan Medical Center Completed Missed primary
Phase 3 NCT00056225 Jan 2003 → Jun 2007 Alzheimer disease National Institute on Aging (NIA) Completed Missed primary
Phase 3 NCT00032435 May 2001 → Aug 2006 end stage renal failure, kidney failure US Department of Veterans Affairs Completed Missed primary
Phase 3 NCT00004734 Sep 1996 → Feb 2004 cerebral infarction, myocardial infarction National Institute of Neurological Disorders and Stroke (NINDS) Completed No outcome recorded
Phase 48 trials · 1 missed
Phase 4 NCT07592897 Jun → Nov 2026 expected — University of Sao Paulo Not yet recruiting No outcome recorded
Phase 4 NCT07029698 Apr → Oct 2025 vitamin B12 deficiency Medice Arzneimittel Pütter GmbH & Co KG Completed No outcome recorded
Phase 4 NCT05221892 Nov 2021 → Mar 2023 — Fundação Educacional Serra dos Órgãos Completed No outcome recorded
Phase 4 NCT05340634 Apr 2020 → Feb 2022 polycystic ovary syndrome Margan Biotech Completed No outcome recorded
Phase 4 NCT03372447 Dec 2017 → Dec 2018 pernicious anemia Hospital Universitario Dr. Jose E. Gonzalez Completed No outcome recorded
Phase 4 NCT03221816 Dec 2008 → Jan 2010 hyperhomocysteinemia, hyperlipidemia Casa de Saúde santa Marcelina Completed No outcome recorded
Phase 4 NCT00140166 Jul 2005 → May 2008 schizophrenia Beersheva Mental Health Center Completed No outcome recorded
Phase 4 NCT00106886 Dec 1999 → Oct 2005 cancer, myocardial infarction, stroke disorder Hamilton Health Sciences Corporation Unknown Missed primary
Phase not applicable13 trials · 1 met primary · 2 missed
— NCT07305519 Apr 2026 → Apr 2027 expected — University of Roma La Sapienza Recruiting No outcome recorded
— NCT06749756 Feb 2025 → Feb 2026 overdue infectious disease with sepsis Fan Zeng Recruiting No outcome recorded
— NCT06445933 Jul 2024 → Sep 2026 overdue postpartum depression National Taiwan University Hospital Recruiting Met primary
— NCT06512441 Jun 2024 → Dec 2025 overdue inflammatory bowel disease Changhai Hospital Recruiting No outcome recorded
— NCT06244121 Jun 2023 → Jun 2024 obsessive-compulsive disorder Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Unknown No outcome recorded
— NCT05918068 Nov 2022 → Apr 2023 type 2 diabetes mellitus Al-Rasheed University College Completed No outcome recorded
— NCT06008223 Nov 2021 → Oct 2022 acute kidney injury, infectious disease with sepsis, inflammatory disease The First People's Hospital of Huzhou Completed No outcome recorded
— NCT01317849 Jul 2011 → Jun 2016 transient ischemic attack Xijing Hospital Withdrawn No outcome recorded Stop: Business
— NCT01474486 Apr 2010 → Feb 2016 cardiomyopathy, congestive heart failure Phoenix VA Health Care System Completed No outcome recorded
— NCT00767689 Mar 2006 → Mar 2009 hand-foot syndrome Cook County Health Terminated No outcome recorded Stop: Enrollment
Comparator or background therapy43 trials
Phase 0 NCT06369350 Comparator Dec 2027 → Sep 2028 expected ischemic disease, peripheral arterial disease Milton S. Hershey Medical Center Not yet recruiting No outcome recorded
Phase 1 NCT05027126 Background Feb → Nov 2019 — Laboratorios Silanes S.A. de C.V. Completed No outcome recorded
Phase 1 NCT00000778 Background — HIV infectious disease, pulmonary tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/2 NCT04708340 Comparator Mar 2021 → Oct 2022 COVID-19, acute respiratory distress syndrome Reven Pharmaceuticals, Inc. Unknown No outcome recorded
Phase 1/2 NCT02589145 Background Jun 2016 → Apr 2019 lymphoma M.D. Anderson Cancer Center Terminated No outcome recorded Stop: Enrollment

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 96 sources stand behind the page.

FieldValueCited text
Known as Pyridoxine “The experimental group received one tablet of Tenavit® (pyridoxine hydrochloride 4.00mg + folic acid 0.80mg + cyanocobalamin 0.40mg) daily and the placebo group received the...” NCT03221816 ↗
52

“Active drug comprised of: ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine, riboflavin 5' phosphate, niacinamide, pyridoxine, calcium d-pantothenate, and...” NCT04708340 ↗

“Participants received a daily capsule containing 40 mg of folic acid, 100 mg of pyridoxine hydrochloride (vitamin B6), and 2 mg of cyanocobalamin (vitamin B12) or a placebo.” PMID 17848650 ↗ Sep 2007

“Each tablet contains 4 active ingredients as follows: Alpha lipoic acid 300mg, Vitamin B12 (methylcobalamin) 500mcg, Vitamin B6 (pyridoxine) 8mg, Vitamin B1 (thiamine) 39mg.” NCT06568185 ↗

“The pyridoxine (50 mg) tablets will be compounded to a suspension of 50 mg/mL, and the participant will take 0.4 mL (20 mg = approximately 1.18 mg/kg) by mouth once daily.” NCT07542548 ↗

“Those with risk factors were recommended a 6-month prophylaxis regimen, consisting of INH (300 mg/d) and pyridoxine (10 mg/d to prevent INH-related neurotoxicity).” NCT06512831 ↗

“Complex B ((Thiamine 100mg, Pyridoxine 5 mg and Cyanocobalamin 50 mcg) 1 tablet enteral route every 6 horas for 4 days or until ICU discharge” NCT04197115 ↗

“including rifampicin 10 mg/kg, isoniazid 5 mg/kg, ethambutol 15 - 20 mg/kg, ± pyrazinamide 25 mg/kg and pyridoxine 10-50 mg per day” NCT06446245 ↗

“Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine” NCT01474486 ↗

“Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.” NCT05837104 ↗

“We gave a combination of vitamin B6 (pyridoxine) and metoclopramide as a treatment for managing nausea and vomiting.” NCT06390787 ↗

Show 42 more sources

Known as B(6) “high-dose folate, vitamin B(6), and vitamin B(12) supplementation” PMID 18854539 ↗ Oct 2008
1

“(2 mg folic acid, 25 mg vitamin B(6), and 500 μg vitamin B(12))” PMID 22554931 ↗ May 2012

Known as pyridoxine HCl “Pyridoxine (pyridoxine HCl) - 10 mg” NCT07592897 ↗
1

“Vitamin B6 (Pyridoxine HCl): 50 mg” NCT00064753 ↗

Known as pyridoxine hydrochloride “Participants received a daily capsule containing 40 mg of folic acid, 100 mg of pyridoxine hydrochloride (vitamin B6), and 2 mg of cyanocobalamin (vitamin B12) or a placebo.” PMID 17848650 ↗ Sep 2007
10

“Diclectin (combination of doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg) , 2-4 tablets/day)” NCT04401384 ↗

“Niacinamide 18 mg/day Pyridoxine Hydrochloride 2.6 mg/day Folic Acid 400 mcg/day” NCT02620345 ↗

“Tablet Pyridoxine hydrochloride (25 mg) 2 tablets thrice daily for 5 weeks.” NCT03593304 ↗

“pyridoxine hydrochloride (vitamin B(6))” PMID 19237716 ↗ Feb 2009

NCT00000778 ↗

NCT02923388 ↗

NCT00000959 ↗

NCT00000638 ↗

NCT00000636 ↗

NCT00614445 ↗

Known as Vit B6 “We aimed at evaluating the effect of vit B6 on inflammation and oxidative stress markers in the liver and lung of rats subjected to a relevant animal model of polymicrobial sepsis.” PMID 31800708 ↗ Dec 2019
1

“Pyridoxine (Vit B6) is a water soluble vitamin, has anti oxidant effects.” NCT06244121 ↗

Known as vitamin B6 “The administration of vitamin B 6 in the treatment of patients with sepsis attenuates renal injury, and the mechanism may be related to pyridoxine decreasing the levels of...” PMID 38691102 ↗ Apr 2024
40

“Specifically for this study, the methyl donor supplement has been made by Jamieson Laboratories, and consists of 50mg Vitamin B6 and 1 mg Vitamin B12, (both within Health...” NCT01864824 ↗

“Each tablet contains 4 active ingredients as follows: Alpha lipoic acid 300mg, Vitamin B12 (methylcobalamin) 500mcg, Vitamin B6 (pyridoxine) 8mg, Vitamin B1 (thiamine) 39mg.” NCT06568185 ↗

“Participants received a daily capsule containing 40 mg of folic acid, 100 mg of pyridoxine hydrochloride (vitamin B6), and 2 mg of cyanocobalamin (vitamin B12) or a placebo.” PMID 17848650 ↗ Sep 2007

“Each capsule is a combination of vitamins and natural products: Vitamin B1 (100mg); Vitamin B6 (50mg); Niacin (200mg); Alpha Lipoic Acid (150mg); and Piperine (15mg).” NCT06242535 ↗

“A daily supplement of 2.5 mg of folic acid, 50 mg of vitamin B(6), and 1 mg of vitamin B(12) or matching placebo for 5 years.” PMID 17470822 ↗ Apr 2007

“200 mg S-adenosylmethionine, 100 mg N-acetylcisteine, 75 mg alpha lipoid acid and 0,65 mg vitamin B6” NCT05340634 ↗

“Pyridoxine or vitamin B6 plays a role in the synthesis of neurotransmitters such as dopamine” NCT05221892 ↗

“All participants in the two groups will receive vitamin B6 (50 mg), once daily, for 5 days.” NCT06625632 ↗

“One group receives INH plus pyridoxine hydrochloride ( vitamin B6 ) daily for six months.” NCT00000959 ↗

“alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg” NCT06940557 ↗

Show 30 more sources

Known as Vitamin B6 Tablets “Drug: Vitamin B6 Tablets” NCT06512441 ↗
Action Inhibit “homocysteine levels can be reduced by administration of high dose supplements of folate (folic acid) and vitamins B6 and B12” NCT00056225 ↗
Modality Other / unclassified “as a dietary supplement” NCT05340634 ↗
Route Oral “Patients receive oral pyridoxine, cyanocobalamin, and oral placebo daily.” NCT00004495 ↗