Pyridoxine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BEROCCA PN | — | 1947-07-28 | fda.gov ↗ |
Trials 47 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 43 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| 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 12 trials | ||||||
| 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 1/24 trials | ||||||
| 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 |
| Phase 1/2 | NCT02701673 Background | Jun 2016 → Jun 2019 | lymphoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01983969 Background | Nov 2013 → Nov 2017 | cancer of unknown primary site, lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT06446245 Background | Aug 2025 → Nov 2027 expected | meningeal tuberculosis | National University Hospital, Singapore | Recruiting | No outcome recorded |
| Phase 2 | NCT03968042 Background | Jun 2019 → Dec 2021 | brain injury | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT02961816 Background | Jun 2017 → Jun 2021 | lymphoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT02114502 Background | Sep 2014 → Sep 2018 | plasma cell myeloma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT01601626 Background | Jul 2013 → Jan 2017 | HIV infectious disease, tuberculosis | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Terminated | No outcome recorded |
| Phase 2 | NCT00070434 Background | Aug 2004 → Feb 2006 | colorectal cancer | SWOG Cancer Research Network | Withdrawn | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06390787 Comparator | Jan → Apr 2024 | — | University of Baghdad | Completed | No outcome recorded |
| Phase 2/3 | NCT06618573 Comparator | Aug 2022 → Dec 2025 overdue | systemic lupus erythematosus, tuberculosis | Padjadjaran University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03593304 Comparator | Mar → Dec 2018 | acute lymphoblastic leukemia, chemotherapy-induced neuropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04197115 Comparator | Sep 2019 → Aug 2020 | infectious disease with sepsis | IMSS Hospital General de Zona 11, Piedras Negras | Completed | No outcome recorded |
| Phase 3 | NCT03785106 Background | Aug 2019 → Mar 2038 expected | — | The HIV Netherlands Australia Thailand Research Collaboration | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00354081 Comparator | Apr 1999 → Jun 2007 | coronary artery disorder, myocardial infarction, stroke disorder | Haukeland University Hospital | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT07542548 Background | Jul 2024 → Mar 2026 | hereditary spastic paraplegia | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05411744 Background | Jul 2022 → Jan 2026 overdue | end stage renal failure, latent tuberculosis infection | Rutgers, The State University of New Jersey | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05008354 Comparator | Oct 2020 → Sep 2021 | epilepsy | Nasim Tabrizi | Completed | No outcome recorded |
| Phase 4 | NCT03278483 Comparator | Feb 2019 | tuberculosis, type 2 diabetes mellitus | National Institute of Public Health, Mexico | Completed | No outcome recorded |
| Phase 4 | NCT03302299 Background | Apr 2017 → Apr 2021 | HIV infectious disease, alcohol abuse, tuberculosis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT02923388 Comparator | Oct 2016 → Jun 2018 | chemotherapy-induced neuropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT02640417 Comparator | Mar 2016 → Mar 2018 | — | Fundação Educacional Serra dos Órgãos | Completed | No outcome recorded |
| Phase 4 | NCT01417988 Comparator | Aug 2011 → Jun 2013 | HIV infectious disease, tuberculosis | Prof JMA Lange | Terminated | No outcome recorded |
| Phase 4 | NCT02620345 Background | Jan 2010 → Oct 2015 | benign neoplasm of corpus uteri | Trieu, Nguyen Thi, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT00763633 Comparator | Jan → Oct 2008 | — | Showa University | Unknown | No outcome recorded |
| Phase 4 | NCT00164281 Background | Nov 2004 → Jul 2009 | HIV infectious disease, tuberculosis | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase not applicable13 trials | ||||||
| — | NCT07354529 Comparator | Jun 2025 → Jan 2026 overdue | pregnancy disorder | Bahria University | Active not recruiting | No outcome recorded |
| — | NCT06625632 Background | Oct 2024 → Jan 2025 overdue | hyperemesis gravidarum | Cairo University | Not yet recruiting | No outcome recorded |
| — | NCT06512831 Background | Jun 2023 → Feb 2024 | isoniazid toxicity, tuberculosis | West China Hospital | Completed | No outcome recorded |
| — | NCT06259747 Background | Feb → Dec 2023 | hyperemesis gravidarum | Kafrelsheikh University | Completed | No outcome recorded |
| — | NCT05024422 Comparator | Dec 2021 → Nov 2022 | lactation disease | HaEmek Medical Center, Israel | Completed | No outcome recorded |
| — | NCT04509401 Comparator | Jan → Nov 2020 | autism spectrum disorder 1 | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| — | NCT01095211 Comparator | Jan 2003 → Sep 2005 | cognitive disorder | Saarland University | Completed | No outcome recorded |
| — | NCT00097669 Comparator | Nov 1998 → Jun 2009 | transient ischemic attack | VITATOPS | Completed | No outcome recorded |
| — | NCT00000796 Background | ? → Oct 1998 | HIV infectious disease, pulmonary tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00000950 Background | ? → May 2002 | HIV infectious disease, tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00000638 Background | ? → Sep 1999 | HIV infectious disease, tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00000959 Background | ? → Jun 1996 | HIV infectious disease, tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00000636 Background | ? → Oct 1997 | HIV infectious disease, tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 96 sources stand behind the page.
| Field | Value | Cited 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 ↗ “Dosage: 25 mg of Dexketoprofen + Cyanocobalamin 500 µg, Thiamine 100 mg, Pyridoxine 50 mg. Administration way: oral” NCT05027126 ↗ “Diclectin (combination of doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg) , 2-4 tablets/day)” NCT04401384 ↗ “Participants will receive 28 days of self-administered daily doses of RPT, INH, and pyridoxine (vitamin B6).” NCT05411744 ↗ “Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.” NCT00164281 ↗ “Vitamin B6 (pyridoxine): up to 200 mg of pyridoxine will be infused over 20 minutes.” NCT03738943 ↗ “pyridoxine (in the form of hydrochloride) 5 mg - take orally” NCT06209229 ↗ “Isoniazid tablets 300mg daily plus pyridoxine 50mg daily” NCT03278483 ↗ “Pyridoxine (pyridoxine HCl) - 10 mg” NCT07592897 ↗ “100 mg daily pyridoxine” NCT01704599 ↗ “pyridoxine 50mg” NCT01417988 ↗ |
| Known as | B(6) | “high-dose folate, vitamin B(6), and vitamin B(12) supplementation” PMID 18854539 ↗ Oct 20081“(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 200710“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 |
| 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 20191“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 202440“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 ↗ “5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day.” NCT01095211 ↗ “Isoniazid/Rifapentine daily (4 weeks) plus pyridoxine (vitamin B6)” NCT03785106 ↗ “folic acid, vitamin B12 (cyanocobalamin), vitamin B6 (pyridoxine)” NCT00354081 ↗ “pyridoxine (Vitamin B6) will be given as an anti oxidant.” NCT06244121 ↗ “Vitamin B6 (Pyridoxine HCl): 50 mg” NCT00064753 ↗ “Pyridoxine (Vitamin B6) 10 mg/day” NCT06618573 ↗ “vitamin B6 (pyridoxine)” NCT01908452 ↗ “Vitamin B6” NCT03302299 ↗ |
| 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 ↗ |