Thiamine
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 64 · started per year
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02465749 Background | May 2015 → Jun 2025 | retinitis pigmentosa | Sun Yat-sen University | Unknown | 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 | NCT01864057 Comparator | Jan → Jul 2012 | beriberi | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04708340 Comparator | Mar 2021 → Oct 2022 | COVID-19, acute respiratory distress syndrome | Reven Pharmaceuticals, Inc. | Unknown | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT05817851 Background | Dec 2023 → Dec 2027 expected | cardiac arrest | Centre Hospitalier de Bethune | Recruiting | No outcome recorded |
| Phase 2 | NCT04921189 Comparator | Dec 2021 → Dec 2024 | cardiac arrest, post-cardiac arrest syndrome | Asan Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03509662 Comparator | Oct 2019 → Feb 2024 | cardiac arrest | Amsterdam UMC, location VUmc | Completed | 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 | NCT03333278 Comparator | May 2018 → Jul 2019 | infectious disease with sepsis | Australian and New Zealand Intensive Care Research Centre | Completed | No outcome recorded |
| Phase 2 | NCT02953184 Background | Nov 2016 → Nov 2019 | — | Jilin University | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00064753 Background | May 2002 → Oct 2011 | cardiovascular disorder, chronic kidney disease | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 32 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 | NCT00861523 Comparator | Feb 2009 → Jan 2012 | hyperemesis gravidarum | HaEmek Medical Center, Israel | Terminated | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT03634735 Comparator | Nov 2018 → Apr 2020 | — | University of Aarhus | Completed | No outcome recorded |
| Phase 4 | NCT03306732 Comparator | Oct 2017 → May 2018 | — | Meshalkin Research Institute of Pathology of Circulation | Completed | No outcome recorded |
| Phase 4 | NCT02640417 Comparator | Mar 2016 → Mar 2018 | — | Fundação Educacional Serra dos Órgãos | Completed | No outcome recorded |
| Phase 4 | NCT02788552 Comparator | Sep 2014 → May 2019 | Wernicke-Korsakoff syndrome | Menzies School of Health Research | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT05585346 Background | Jan 2021 → Feb 2023 | Bell's palsy | Beijing Tongren Hospital | Completed | No outcome recorded |
| — | NCT04216459 Comparator | Feb → Nov 2020 | infectious disease with sepsis | Mansoura University | Completed | No outcome recorded |
| — | NCT04137276 Background | Apr → Jul 2019 | infectious disease with sepsis | Indonesia University | Completed | No outcome recorded |
| — | NCT03649009 Comparator | Jan → Dec 2018 | lactic acidosis | Universiti Kebangsaan Malaysia Medical Centre | Unknown | No outcome recorded |
| — | NCT03258684 Comparator | Sep 2017 → Feb 2019 | infectious disease with sepsis | Zhujiang Hospital | Completed | No outcome recorded |
| — | NCT02767245 Comparator | Jan 2014 → Jul 2016 | thyrotoxicosis | Ramathibodi Hospital | Completed | No outcome recorded |
| — | NCT00770107 Comparator | Jun 2004 → Dec 2009 | heart failure | Luzerner Kantonsspital | Completed | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 89 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | thiamine | “Active drug comprised of: ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine, riboflavin 5' phosphate, niacinamide, pyridoxine, calcium d-pantothenate, and...” NCT04708340 ↗64“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 ↗ “gabapentin (GBP) plus complex B vitamins: thiamine (B1) and cyanocobalamine (B12) compared to pregabalin in patients with moderate to severe intensity PDN.” PMID 26885528 ↗ Jan 2016 “Intervention group will receive intravenous hydrocortisone (200mg every 24 hours), vitamin C (1.5g every 6 hours), and thiamine (200 mg every 12 hours).” NCT06723626 ↗ “intravenous Thiamine (200mg in 50 mL of 0.9% normal saline and was administered as a 30-min infusion every 12 hours for 4 days or until ICU discharge)” NCT04039815 ↗ “and thiamine (200 mg every 12 hours administered as an infusion over 30 to 60 minutes and mixed in a 100-mL solution of normal saline) for 3 days.” NCT06152458 ↗ “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 ↗ “receiving intravenous Vitamin C (1.5 g every 6 hours), Thiamine (200 mg every 12 hours) and Hydrocortisone (50 mg every 6 hours) for 7 days” NCT05192213 ↗ “Patients were assigned randomly to receive thiamine (300 mg in 0.9% Normal saline solution) or placebo (0.9% Normal saline) preoperatively.” PMID 26066773 ↗ Aug 2015 “In addition, all patients will receive intravenous thiamine 200 mg twice a day for 3 days to limit the oxalate production.” NCT05817851 ↗ “Dosage: 25 mg of Dexketoprofen + Cyanocobalamin 500 µg, Thiamine 100 mg, Pyridoxine 50 mg. Administration way: oral” NCT05027126 ↗ “MGO cocktail containing a combination of alpha-lipoic acid, nicotinamide, thiamine, pyridoxamine, and piperine” NCT05083546 ↗ “This is a oral supplement combination of tryptophan and thiamine called TK3 to be taken three times a day” NCT03341286 ↗ “Patients in Arm 1 will randomized to receive usual care + hydrocortisone, thiamine and ascorbic acid.” NCT04134403 ↗ “patients will receive intravenous thiamine 200mg q 12 hourly for 4 days or until ICU discharge.” NCT03828929 ↗ “hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT” NCT05157360 ↗ “Thiamine (thiamine mononitrate) - 10 mg” NCT07592897 ↗ “Hydrocortisone, Vitamin C and Thiamine” NCT03380507 ↗ |
| Known as | Bevitine | “Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine)” NCT05817851 ↗ |
| Known as | Thiamin | “Thiamine (vitamin B1) is a water-soluble vitamin and is involved in several stages of intermediate metabolism which are important for producing energy.” NCT01524315 ↗3“Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin” NCT01474486 ↗ |
| Known as | Thiamine HNO3 | “Vitamin B1 (Thiamine HNO3): 1.5 mg” NCT00064753 ↗ |
| Known as | Thiamine hydrochloride | “Thiamine hydrochloride (vitamin B1) 500mg IV will be given every 12 hours for 5 doses in the experimental arm.” NCT03450707 ↗ |
| Known as | Thiamine Hydrocloride | “Patients in this arm will receive a solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9%.” NCT04641104 ↗ |
| Known as | thiamine mononitrate | “Thiamine (thiamine mononitrate) - 10 mg” NCT07592897 ↗1“Drug: Thiamine Mononitrate” NCT03989700 ↗ |
| Known as | Thiamine: brand name: Thiamine Hakim | “Thiamine: brand name: Thiamine Hakim” NCT01115504 ↗ |
| Known as | vitamin B | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02953184 ↗ |
| Known as | Vitamin B1 | “A small retrospective study demonstrated a mortality benefit by using high dose vitamin C, thiamine (vitamin B1), and hydrocortisone (Triple therapy) for treatment of septic...” NCT04508946 ↗26“Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose.” NCT04641104 ↗ “Deficiencies in thiamine (vitamin B1) and riboflavin (vitamin B2) have been implicated as cofactors in producing hyperlactatemia and lactic acidosis in NRTI-treated patients.” NCT00031057 ↗ “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 ↗ “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 ↗ “Thiamine (vitamin B1) is a water-soluble vitamin and is involved in several stages of intermediate metabolism which are important for producing energy.” NCT01524315 ↗ “This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in patients with diabetic peripheral neuropathy.” NCT00279266 ↗ “vitamin B1 (100mg) will be diluted in 50 ml 0.9% NACL(normal saline) and administered IV every 6 hours for 3 days” NCT05663164 ↗ “Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.” NCT03821714 ↗ “Supplementation of thiamine (vitamin b1) 300 mg per day, once daily, for a duration of 4 weeks” NCT00770107 ↗ “hydrocortisone, ascorbic acid (vitamin C), and thiamine (vitamin B1); referred to as HAT” NCT05157360 ↗ “alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6; 8mg” NCT06940557 ↗ “Thiamine (Vitamin B1) is an essential component for cellular metabolism.” NCT03649009 ↗ “Thiamine or vitamin B1 is a cofactor in the synthesis of acetylcholine” NCT05221892 ↗ “Vitamin B1 (Thiamine HNO3): 1.5 mg” NCT00064753 ↗ |
| Known as | Vitamin B1 or Thiamin or Thiamine or Aneurin | “Vitamin B1 or Thiamin or Thiamine or Aneurin” NCT02087462 ↗ |
| Known as | Vitamin B1-injektopas | “thiamine (Vitamin B1-injektopas®, Ampoule, Germany, 100 mg / 2 ml) 200 mg diluted in 10 ml normal saline IV /12 h” NCT04160676 ↗ |
| Action | Activate | “Thiamine (vitamin B1) is a key co-factor for PDH function and will increase activity even in non-deficient states.” NCT02322892 ↗ |
| Modality | Other / unclassified | “combination of AOX micronutrient supplements” NCT00515736 ↗ |
| Route | Oral | “every patient receives high-dose oral vitamin B1 and B2 therapy for 4 weeks.” NCT00031057 ↗ |