{"id":"thiamine","rwe":[],"_fda":{"id":"3972cf2f-88ce-e507-e063-6394a90a8da5","set_id":"06446e9a-0e85-0623-e063-6294a90ac403","openfda":{"unii":["M572600E5P"],"route":["INTRAMUSCULAR","INTRAVENOUS"],"rxcui":["313324"],"spl_id":["3972cf2f-88ce-e507-e063-6394a90a8da5"],"brand_name":["THIAMINE HYDROCHLORIDE injection, solution"],"spl_set_id":["06446e9a-0e85-0623-e063-6294a90ac403"],"package_ndc":["51662-1635-1"],"product_ndc":["51662-1635"],"generic_name":["THIAMINE HYDROCHLORIDE INJECTION, SOLUTION"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["THIAMINE HYDROCHLORIDE"],"manufacturer_name":["HF Acquisition Co LLC, DBA HealthFirst"],"application_number":["ANDA080571"],"original_packager_product_ndc":["43598-050"]},"version":"3","warnings":["WARNINGS WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Serious hypersensitivity/anaphylactic reactions can occur, especially after repeated administration. Deaths have resulted from IV or IM administration of thiamine (see ADVERSE REACTIONS ). Routine testing for hypersensitivity, in many cases, may not detect hypersensitivity. Nevertheless, a skin test should be performed on patients who are suspected of drug allergies or previous reactions to thiamine, and any positive responders should not receive thiamine by injection. If hypersensitivity to thiamine is suspected (based on history of drug allergy or occurrence of adverse reactions after thiamine administration), administer one-hundredth of the dose intradermally and observe for 30 minutes. If no reaction occurs, full dose can be given; the patient should be observed for at least 30 minutes after injection. Be prepared to treat anaphylactic reactions regardless of the precautions taken. Treatment of anaphylactic reactions includes maintaining a patent airway and the use of epinephrine, oxygen, vasopressors, steroids and antihistamines."],"overdosage":["OVERDOSAGE Parenteral doses of 100 to 500 mg singly have been administered without toxic effects. However, dosages exceeding 30 mg three times a day are not utilized effectively. When the body tissues are saturated with thiamine, it is excreted in the urine as pyrimidine. As the intake of thiamine is further increased, it appears unchanged in the urine."],"description":["DESCRIPTION Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride, USP in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride, USP 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; water for injection, q.s. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH between 2.5 and 4.5 Thiamine hydrochloride, USP or vitamin B1, occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution. The chemical name of thiamine hydrochloride, USP is thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula: Structure"],"precautions":["PRECAUTIONS General Simple vitamin B1 deficiency is rare. Multiple vitamin deficiencies should be suspected in any case of dietary inadequacy. Information for Patients The patient should be advised as to proper dietary habits during treatment so that relapses will be less likely to occur with reduction in dosage or cessation of injection therapy. Usage in Pregnancy Studies in pregnant women have not shown that thiamine hydrochloride increases the risk of fetal abnormalities if administered during pregnancy. If the drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm however, thiamine hydrochloride should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when thiamine hydrochloride is administered to a nursing mother."],"how_supplied":["HOW SUPPLIED Thiamine Hydrochloride Injection, USP is supplied as follows Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Use only if solution is clear and seal intact. Distributor: HF ACQUISITION CO LLC, DBA HEALTHFIRST 11629 49TH PL W. MUKILTEO, WA 98275 HOW SUPPLIED"],"effective_time":"20250708","adverse_reactions":["ADVERSE REACTIONS An occasional individual may develop a hypersensitivity or life threatening anaphylactic reaction to thiamine, especially after repeated injections. Collapse and death have been reported. A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat, angioneurotic edema, cyanosis, pulmonary edema, and hemorrhage into the gastrointestinal tract have also been reported. Some tenderness and induration may follow IM use (see WARNINGS )."],"contraindications":["CONTRINDICATIONS A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See WARNINGS for further information.)"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The water soluble vitamins are widely distributed in both plants and animals. They are absorbed in man by both diffusion and active transport mechanisms. These vitamins are structurally diverse (derivatives of sugar, pyridine, purines, pyrimidine, organic acid complexes and nucleotide complex) and act as coenzymes, as oxidation-reduction agents, possibly as mitochondrial agents. Metabolism is rapid, and the excess is excreted in the urine. Thiamine is distributed in all tissues. The highest concentrations occur in liver, brain, kidney and heart. When thiamine intake is greatly in excess of need, tissue stores increase two to three times. If intake is insufficient, tissues become depleted of their vitamin content. Absorption of thiamine following IM administration is rapid and complete. Thiamine combines with adenosine triphosphate (ATP) to form thiamine pyrophosphate, also known as cocarboxylase, a coenzyme. Its role in carbohydrate metabolism is the decarboxylation of pyruvic acid in the blood and α-ketoacids to acetaldehyde and carbon dioxide. Increased levels of pyruvic acid in the blood indicate vitamin B1 deficiency. The requirement for thiamine is greater when the carbohydrate content of the diet is raised. Body depletion of vitamin B1 can occur after approximately three weeks of total absence of thiamine in the diet."],"indications_and_usage":["INDICATIONS Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke's encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given."],"spl_unclassified_section":["To report SUSPECTED ADVERSE REACTIONS, contact HF Acquisition Co LLC, DBA HealthFirst at 1-800-331- 1984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION \"Wet\" beriberi with myocardial failure must be treated as an emergency cardiac condition, and thiamine must be administered slowly by the IV route in this situation (see WARNINGS ). In the treatment of beriberi, 10 to 20 mg of thiamine hydrochloride are given IM three times daily for as long as two weeks. (See WARNINGS regarding repeated injection of thiamine.) An oral therapeutic multivitamin preparation containing 5 to 10 mg thiamine, administered daily for one month, is recommended to achieve body tissue saturation. Infantile beriberi that is mild may respond to oral therapy, but if collapse occurs, doses of 25 mg may cautiously be given IV. Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed. Patients with neuritis of pregnancy in whom vomiting is severe enough to preclude adequate oral therapy should receive 5 to 10 mg of thiamine hydrochloride IM daily. In the treatment of Wernicke-Korsakoff syndrome, thiamine hydrochloride has been administered IV in an initial dose of 100 mg, followed by IM doses of 50 to 100 mg daily until the patient is consuming a regular, balanced diet. (See WARNINGS regarding repeated injections of thiamine.) Patients with marginal thiamine status to whom dextrose is being administered should receive 100 mg thiamine hydrochloride in each of the first few liters of IV fluid to avoid precipitating heart failure. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."],"spl_product_data_elements":["THIAMINE HYDROCHLORIDE injection, solution THIAMINE HYDROCHLORIDE injection, solution THIAMINE HYDROCHLORIDE THIAMINE ION WATER SODIUM HYDROXIDE"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL, MFG LABEL ORIGINAL MFG LABEL","PRINCIPAL DISPLAY PANEL, SERIALIZATION LABEL 51662-1635-1 SERIALIZED LABEL Label","PRINCIPAL DISPLAY PANEL Rx only NDC 51662-1635-1 Thiamine HCl Injection, USP 200 mg/2 mL(100 mg/mL) For intramuscular or intravenous use. Protect from light. Sterile. Each mL contains: Thiamine HCl, USP 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; water for injection, q.s. to 1 mL Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH between 2.5 and 4.5. Contains no more than 400 mcg/L of aluminum."]},"tags":[{"label":"thiamine (vit B1)","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Heat shock protein HSP 90-alpha","category":"target"},{"label":"HSP90AA1","category":"gene"},{"label":"TPK1","category":"gene"},{"label":"SLC19A2","category":"gene"},{"label":"A11DA01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Cobalamin deficiency","category":"indication"},{"label":"Korsakoff's psychosis","category":"indication"},{"label":"Mineral Deficiency Prevention","category":"indication"},{"label":"Mineral deficiency","category":"indication"},{"label":"Pernicious anemia","category":"indication"},{"label":"Prevention of Vitamin B12 Deficiency","category":"indication"},{"label":"Hospira","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Micronutrients","category":"pharmacology"},{"label":"Vitamin B Complex","category":"pharmacology"},{"label":"Vitamins","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"3893 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"2982 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"2888 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"2544 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"2432 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"2360 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"2217 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"2113 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"2094 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"1798 reports"}],"commonSideEffects":[{"effect":"Hypersensitivity","drugRate":"reported","severity":"unknown"},{"effect":"Anaphylactic reaction","drugRate":"reported","severity":"unknown"},{"effect":"Collapse","drugRate":"reported","severity":"unknown"},{"effect":"Death","drugRate":"reported","severity":"unknown"},{"effect":"Pulmonary edema","drugRate":"reported","severity":"unknown"},{"effect":"Hemorrhage into the gastrointestinal tract","drugRate":"reported","severity":"unknown"},{"effect":"Angioneurotic edema","drugRate":"reported","severity":"unknown"},{"effect":"Cyanosis","drugRate":"reported","severity":"unknown"},{"effect":"Tenderness","drugRate":"reported","severity":"unknown"},{"effect":"Induration","drugRate":"reported","severity":"unknown"},{"effect":"Feeling of warmth","drugRate":"reported","severity":"unknown"},{"effect":"Pruritus","drugRate":"reported","severity":"unknown"},{"effect":"Urticaria","drugRate":"reported","severity":"unknown"},{"effect":"Weakness","drugRate":"reported","severity":"unknown"},{"effect":"Sweating","drugRate":"reported","severity":"unknown"},{"effect":"Nausea","drugRate":"reported","severity":"unknown"},{"effect":"Restlessness","drugRate":"reported","severity":"unknown"},{"effect":"Tightness of the throat","drugRate":"reported","severity":"unknown"}],"contraindications":["Acute Thromboembolic Stroke","Agoraphobia","Alcoholism","Atrophic gastritis","Blood coagulation disorder","Cardiovascular event risk","Chronic heart failure","Conduction disorder of the heart","Coronary artery bypass graft","Disease of liver","Gastrectomy","Gastrointestinal hemorrhage","Gastrointestinal perforation","Gastrointestinal ulcer","Hemophilia","Hepatic failure","Hypertensive disorder","Hypokalemia","Impaired renal function disorder","Insomnia","Kidney disease","Leber's optic atrophy","Myocardial infarction","Myocardial infarction in recovery phase","Myocardial ischemia"],"specialPopulations":{"Pregnancy":"If the drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm however, thiamine hydrochloride should be used during pregnancy only if clearly needed."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-09-18","unitCost":"$2.6618/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$958","description":"THIAMINE 200 MG/2 ML VIAL","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=THIAMINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:47:55.164343+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:48:02.607696+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:47:53.805020+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=THIAMINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:48:03.260354+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:47:52.586798+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:47:52.586858+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:48:04.798989+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1588/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:48:03.729768+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA080571","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:47:52.586869+00:00"}},"allNames":"thiamine hydrochloride","offLabel":[],"synonyms":["thiamine","vitamin B1","thiamine hydrochloride","thiamine mononitrate","thiamine (vit B1)","thiamine HCl"],"timeline":[{"date":"1993-12-29","type":"positive","source":"DrugCentral","milestone":"FDA approval (Hospira)"}],"aiSummary":"Thiamine Hydrochloride (THIAMINE) is a thiamine (vitamin B1) small molecule developed by HOSPIRA, currently owned by the same company. It targets heat shock protein HSP 90-alpha and is FDA-approved since 1993 for various indications including cobalamin deficiency, Korsakoff's psychosis, and mineral deficiency prevention. THIAMINE is available as a generic medication with 20 manufacturers and is off-patent. Key safety considerations include its low bioavailability of 4%. It is used to treat various vitamin and mineral deficiencies.","approvals":[{"date":"1993-12-29","orphan":false,"company":"HOSPIRA","regulator":"FDA"}],"brandName":"Thiamine Hydrochloride","ecosystem":[{"indication":"Cobalamin deficiency","otherDrugs":[{"name":"cobalamin","slug":"cobalamin","company":""},{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"hydroxocobalamin","slug":"hydroxocobalamin","company":"Watson Labs"}],"globalPrevalence":null},{"indication":"Korsakoff's psychosis","otherDrugs":[],"globalPrevalence":null},{"indication":"Mineral Deficiency Prevention","otherDrugs":[{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"},{"name":"folic acid","slug":"folic-acid","company":"Lederle"},{"name":"retinol","slug":"retinol","company":"Hospira"},{"name":"riboflavin","slug":"riboflavin","company":"Hospira"}],"globalPrevalence":null},{"indication":"Mineral deficiency","otherDrugs":[{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"},{"name":"folic acid","slug":"folic-acid","company":"Lederle"},{"name":"retinol","slug":"retinol","company":"Hospira"},{"name":"riboflavin","slug":"riboflavin","company":"Hospira"}],"globalPrevalence":null},{"indication":"Pernicious anemia","otherDrugs":[{"name":"cobalamin","slug":"cobalamin","company":""},{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"hydroxocobalamin","slug":"hydroxocobalamin","company":"Watson Labs"}],"globalPrevalence":null},{"indication":"Prevention of Vitamin B12 Deficiency","otherDrugs":[{"name":"cobalamin","slug":"cobalamin","company":""},{"name":"cobamamide","slug":"cobamamide","company":""},{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"folic acid","slug":"folic-acid","company":"Lederle"}],"globalPrevalence":null},{"indication":"Thiamin deficiency","otherDrugs":[],"globalPrevalence":null},{"indication":"Vitamin Deficiency Prevention","otherDrugs":[{"name":"cyanocobalamin","slug":"cyanocobalamin","company":""},{"name":"ergocalciferol","slug":"ergocalciferol","company":"Sanofi Aventis Us"},{"name":"ferrous sulfate","slug":"ferrous-sulfate","company":"Lederle"},{"name":"folic acid","slug":"folic-acid","company":"Lederle"}],"globalPrevalence":null}],"mechanism":{"target":"Heat shock protein HSP 90-alpha","novelty":"First-in-class","targets":[{"gene":"HSP90AA1","source":"DrugCentral","target":"Heat shock protein HSP 90-alpha","protein":"Heat shock protein HSP 90-alpha"},{"gene":"TPK1","source":"DrugCentral","target":"Thiamin pyrophosphokinase 1","protein":"Thiamin pyrophosphokinase 1"},{"gene":"SLC19A2","source":"DrugCentral","target":"Thiamine transporter 1","protein":"Thiamine transporter 1"},{"gene":"THTPA","source":"DrugCentral","target":"Thiamine-triphosphatase","protein":"Thiamine-triphosphatase"},{"gene":"TKT","source":"DrugCentral","target":"Transketolase","protein":"Transketolase"},{"gene":"TKTL1","source":"DrugCentral","target":"Transketolase-like protein 1","protein":"Transketolase-like protein 1"}],"modality":"Small Molecule","drugClass":"thiamine (vit B1)","explanation":"","oneSentence":"","technicalDetail":"Thiamine Hydrochloride binds to the ATP-binding site of heat shock protein HSP 90-alpha, inhibiting its chaperone activity and leading to the degradation of client proteins, including those involved in cancer cell growth and survival."},"commercial":{"launchDate":"1993","_launchSource":"DrugCentral (FDA 1993-12-29, HOSPIRA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2832","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=THIAMINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=THIAMINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T15:53:44.772373","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:48:08.134823+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"amprolium","drugSlug":"amprolium","fdaApproval":"","relationship":"same-target"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"thiamine","indications":{"approved":[{"name":"Cobalamin deficiency","source":"DrugCentral","snomedId":190634004,"regulator":"FDA"},{"name":"Korsakoff's psychosis","source":"DrugCentral","snomedId":69482004,"regulator":"FDA"},{"name":"Mineral Deficiency Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Mineral deficiency","source":"DrugCentral","snomedId":111379007,"regulator":"FDA"},{"name":"Pernicious anemia","source":"DrugCentral","snomedId":84027009,"regulator":"FDA"},{"name":"Prevention of Vitamin B12 Deficiency","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Thiamin deficiency","source":"DrugCentral","snomedId":399357009,"regulator":"FDA"},{"name":"Vitamin Deficiency Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Vitamin deficiency","source":"DrugCentral","snomedId":85670002,"regulator":"FDA"}],"offLabel":[{"name":"Methylmalonic acidemia","source":"DrugCentral","drugName":"THIAMINE","evidenceCount":6,"evidenceLevel":"emerging"}],"pipeline":[]},"drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"amprolium","brandName":"amprolium","genericName":"amprolium","approvalYear":"","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT07450833","phase":"PHASE1","title":"Safety, Tolerability and Pharmacokinetics of Benfo-Oxythiamine (B-OT) in Healthy Volunteers","status":"COMPLETED","sponsor":"Benfovir AG","startDate":"2022-03-01","conditions":["Healthy Volunteers"],"enrollment":48,"completionDate":"2022-11-21"},{"nctId":"NCT05385042","phase":"NA","title":"Iron and Immune Response to Vaccine (IRONMUM)","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2022-06-18","conditions":["Pregnancy Related"],"enrollment":171,"completionDate":"2025-07-22"},{"nctId":"NCT06298344","phase":"EARLY_PHASE1","title":"The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease","status":"COMPLETED","sponsor":"Universitas Sumatera Utara","startDate":"2024-05-01","conditions":["Congenital Heart Disease","Thiamine Deficiency","Patent Ductus Arteriosus","Ventricular Septal Defect","Atrial Septal Defect"],"enrollment":86,"completionDate":"2025-12-30"},{"nctId":"NCT07475299","phase":"NA","title":"Synbiotic Supplement With Botanical Extracts for Gut Microbiota Balance in Irritable Bowel Syndrome","status":"NOT_YET_RECRUITING","sponsor":"Iuliu Hatieganu University of Medicine and Pharmacy","startDate":"2026-04","conditions":["Irritable Bowel Syndrome (IBS)"],"enrollment":8,"completionDate":"2027-01"},{"nctId":"NCT06322212","phase":"EARLY_PHASE1","title":"Type 2 Diabetes and Blood Brain Barrier Improvement","status":"RECRUITING","sponsor":"University of California, Los Angeles","startDate":"2024-08-01","conditions":["Type2diabetes"],"enrollment":52,"completionDate":"2027-03-31"},{"nctId":"NCT07405814","phase":"NA","title":"Clinical Trial On The Effect Of Artisterol On Risk Factors In Individuals With Suboptimal Cholesterol Levels","status":"NOT_YET_RECRUITING","sponsor":"Zentiva, k.s.","startDate":"2026-02-02","conditions":["Hyperlipoproteinemia"],"enrollment":106,"completionDate":"2026-10-31"},{"nctId":"NCT07398885","phase":"NA","title":"Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial","status":"COMPLETED","sponsor":"University Tunis El Manar","startDate":"2024-07-01","conditions":["System; Lupus Erythematosus"],"enrollment":59,"completionDate":"2025-05-07"},{"nctId":"NCT07380438","phase":"NA","title":"A Clinical Study to Evaluate the Efficacy of a Nutritional Supplement to Improve Carotenoid Content as Measured by a Non-invasive Hyperspectral Absorption Device","status":"COMPLETED","sponsor":"Pharmanex","startDate":"2025-10-20","conditions":["Nutrition Assessment"],"enrollment":84,"completionDate":"2026-01-08"},{"nctId":"NCT05480943","phase":"","title":"Prevalence of Thiamine Deficiency in Hospitalized Non-Alcoholic Veterans","status":"COMPLETED","sponsor":"VA Office of Research and Development","startDate":"2022-07-19","conditions":["Thiamine Deficiency","Thiamine Deficiency; Sequelae"],"enrollment":206,"completionDate":"2024-12-30"},{"nctId":"NCT07193927","phase":"PHASE2","title":"Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic 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