Thiamine - PharmaKB

Thiamine

Berocca Pn, Infuvite, M.v.c. 9+, M.v.i, M.v.i. Lyophilized, Mvc, Thiamine, Vitaped (thiamine) is a small molecule pharmaceutical. Thiamine was first approved as Thiamine hydrochloride on 1982-01-01. It is used to treat alcoholic neuropathy, beriberi, pellagra, thiamine deficiency, and wernicke encephalopathy in the USA. It is known to target thiamine transporter 1 and thiamine transporter 2.

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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nervous system diseases	D009422
nutritional and metabolic diseases	D009750
chemically-induced disorders	D064419
mental disorders	D001523

Trade Name

FDA

EMA

Thiamine (discontinued: Betalin, Thiamine)

Combinations

Infuvite (discontinued: Berocca pn, M.v.c. 9+, M.v.i., M.v.i. lyophilized, Mvc, Vitaped)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Ascorbic acid

Biotin

Cyanocobalamin

Dexpanthenol

Ergocalciferol

Folic acid

Niacinamide

Pyridoxine hydrochloride

Riboflavin 5'-phosphate sodium

Thiamine hydrochloride

Vitamin a palmitate

Vitamin e

Tradename	Company	Number	Date	Products
BEROCCA PN	Roche	N-006071 DISCN	1985-10-10	1 products

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Alpha-tocopherol acetate

Ascorbic acid

Biotin

Cholecalciferol

Cyanocobalamin

Dexpanthenol

Folic acid

Niacinamide

Pyridoxine hydrochloride

Riboflavin 5'-phosphate sodium

Thiamine hydrochloride

Vitamin a palmitate

Vitamin k

Tradename	Company	Number	Date	Products
INFUVITE ADULT	Sandoz	N-021163 RX	2000-05-18	2 products, RLD, RS

Ascorbic acid

Biotin

Cholecalciferol

Cyanocobalamin

Dexpanthenol

Folic acid

Niacinamide

Pyridoxine

Riboflavin

Thiamine

Tocopherol acetate

Vitamin a

Vitamin k

Tradename	Company	Number	Date	Products
INFUVITE PEDIATRIC	Sandoz	N-021265 RX	2001-02-21	1 products, RLD, RS
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)	Sandoz	N-021265 RX	2004-01-29	1 products, RLD, RS

Ascorbic acid

Biotin

Cyanocobalamin

Dexpanthenol

Ergocalciferol

Folic acid

Niacinamide

Pyridoxine hydrochloride

Riboflavin 5'-phosphate sodium

Thiamine hydrochloride

Vitamin a

Vitamin e

Tradename	Company	Number	Date	Products
M.V.C. 9+3	APP Pharmaceuticals	N-018440 DISCN	1985-08-08	1 products
M.V.I.-12 ADULT	Hospira	N-008809 DISCN	1985-08-08	2 products
MVC PLUS	Allergan	N-018439 DISCN	1985-08-08	1 products

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Ascorbic acid

Biotin

Cyanocobalamin

Dexpanthenol

Ergocalciferol

Folic acid

Niacinamide

Pyridoxine hydrochloride

Riboflavin

Thiamine hydrochloride

Vitamin a

Vitamin e

Tradename	Company	Number	Date	Products
M.V.I.-12 ADULT	Hospira	N-008809 DISCN	2004-04-22	1 products

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Ascorbic acid

Biotin

Cyanocobalamin

Dexpanthenol

Ergocalciferol

Folic acid

Niacinamide

Phytonadione

Pyridoxine hydrochloride

Riboflavin 5'-phosphate sodium

Thiamine hydrochloride

Vitamin a

Vitamin e

Tradename	Company	Number	Date	Products
M.V.I. PEDIATRIC	Hospira	N-018920 DISCN	2000-09-21	1 products, RLD

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Ascorbic acid

Biotin

Cyanocobalamin

Dexpanthenol

Ergocalciferol

Folic acid

Niacinamide

Pyridoxine hydrochloride

Riboflavin 5'-phosphate sodium

Thiamine hydrochloride

Vitamin a

Vitamin e

Vitamin k

Tradename	Company	Number	Date	Products
M.V.I. ADULT	Hospira	N-021625 DISCN	2004-01-30	1 products, RLD
M.V.I. ADULT (PHARMACY BULK PACKAGE)	Hospira	N-021643 DISCN	2004-02-18	1 products, RLD

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Ascorbic acid

Biotin

Cyanocobalamin

Ergocalciferol

Folic acid

Niacinamide

Pantothenic acid

Phytonadione

Pyridoxine

Riboflavin

Thiamine

Vitamin a palmitate

Vitamin e

Tradename	Company	Number	Date	Products
VITAPED	Hospira	N-020176 DISCN	1993-12-29	1 products

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Ascorbic acid

Biotin

Cyanocobalamin

Dexpanthenol

Ergocalciferol

Folic acid

Niacinamide

Pyridoxine

Riboflavin 5'-phosphate sodium

Thiamine

Vitamin a

Vitamin e

Tradename	Company	Number	Date	Products
M.V.I.-12 LYOPHILIZED	Teligent	N-018933 DISCN	1985-08-08	1 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
adult infuvite multiple vitamins	New Drug Application	2019-05-14
anubis barcelona regul oil	OTC monograph final	2023-09-01
bacmin	unapproved drug other	2014-05-02
bal-care dha	unapproved drug other	2012-05-01
bal-care dha essential	unapproved drug other	2012-05-01
biovita	unapproved drug other	2019-01-14
c-nate dha	unapproved drug other	2024-01-22
centratex	unapproved drug other	2024-01-31
citranatal 90 dha	unapproved drug other	2024-01-08
citranatal assure	unapproved drug other	2024-01-08

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
alcoholic neuropathy	EFO_1000803	D020269	G62.1
thiamine deficiency	—	D013832	E51
wernicke encephalopathy	EFO_1001241	D014899	E51.2
beriberi	EFO_1000837	D001602	E51.1
pellagra	—	D010383	—
hypercholesterolemia	—	D006937	—
hypophosphatemia	HP_0002148	D017674	—
hypertriglyceridemia	EFO_0004211	D015228	—
peripheral vascular diseases	EFO_0003875	D016491	I73.9
dermatitis	—	D003872	L30.9

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Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

A: Alimentary tract and metabolism drugs

— A11: Vitamins

— A11D: Vitamin b1, plain and in combination with vitamin b6 and b12

— A11DA: Vitamin b1, plain

— A11DA01: Thiamine (vit b1)

HCPCS

Code	Description
J3411	Injection, thiamine hcl, 100 mg

Clinical

Clinical Trials

292 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Septic shock	D012772	—	A48.3	3	10	9	2	7	27
Thiamine deficiency	D013832	—	E51	4	5	1	5	9	23
Beriberi	D001602	EFO_1000837	E51.1	5	4	1	5	9	23
Shock	D012769	—	R57.1	3	8	7	2	5	22
Sepsis	D018805	EFO_0001420	A41.9	1	8	6	2	5	20
Anemia	D000740	EFO_0004272	D64.9	—	—	2	2	14	18
Toxemia	D014115	—	—	1	5	4	1	3	12
Malnutrition	D044342	EFO_0008572	E40-E46	—	1	—	1	9	11
Iron deficiencies	D000090463	—	E61.1	—	—	—	1	9	10
Syndrome	D013577	—	—	—	1	1	2	6	10

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Diabetes mellitus	D003920	EFO_0000400	E08-E13	1	3	3	—	7	13
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	1	3	1	—	4	8
Diarrhea	D003967	—	R19.7	—	—	1	—	6	7
Diabetic neuropathies	D003929	EFO_1000783	—	—	2	3	—	2	6
Pregnancy	D011247	EFO_0002950	Z33.1	2	—	2	—	2	6
Colorectal neoplasms	D015179	—	—	2	—	2	—	1	5
Peripheral nervous system diseases	D010523	—	G64	—	1	1	—	3	4
Tuberculosis	D014376	EFO_0000774	A15-A19	—	—	4	—	—	4
Ischemia	D007511	EFO_0000556	—	1	1	1	—	1	3
Wounds and injuries	D014947	—	T14.8	—	1	1	—	1	3

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	1	2	—	—	4	7
Neoplasms	D009369	—	C80	2	4	—	—	—	6
Heart arrest	D006323	EFO_0009492	I46	—	5	—	—	—	5
Micronutrients	D018977	—	—	—	1	—	—	3	4
Infections	D007239	EFO_0000544	—	1	1	—	—	2	3
Delirium	D003693	—	R41.0	—	1	—	—	1	2
Post-cardiac arrest syndrome	D000080942	—	—	—	2	—	—	—	2
Coronary artery bypass	D001026	EFO_0003776	—	1	1	—	—	—	2
Respiratory insufficiency	D012131	—	J96.9	—	1	—	—	1	2
Cognitive dysfunction	D060825	—	G31.84	1	1	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Inflammation	D007249	MP_0001845	—	1	—	—	—	5	6
Vitamin d deficiency	D014808	EFO_0003762	E55	1	—	—	—	3	4
Hypertension	D006973	EFO_0000537	I10	1	—	—	—	1	2
Nutritional status	D009752	—	—	1	—	—	—	1	2
Metabolic diseases	D008659	EFO_0000589	E88.9	1	—	—	—	1	2
Depression	D003863	—	F33.9	1	—	—	—	1	2
Burns	D002056	—	T30.0	1	—	—	—	1	2
Carcinoma	D002277	—	C80.0	2	—	—	—	—	2
Pancreatic ductal carcinoma	D021441	—	—	2	—	—	—	—	2
Non-small-cell lung carcinoma	D002289	—	—	2	—	—	—	—	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Constipation	D003248	—	K59.0	—	—	—	—	3	3
Growth disorders	D006130	—	—	—	—	—	—	3	3
Avitaminosis	D001361	EFO_0005878	E56.9	—	—	—	—	2	2
Menopause	D008593	EFO_0003922	N95	—	—	—	—	2	2
Climacteric	D002979	—	—	—	—	—	—	2	2
Autistic disorder	D001321	EFO_0003758	F84.0	—	—	—	—	2	2
Diabetes complications	D048909	—	—	—	—	—	—	2	2
Folic acid deficiency	D005494	EFO_0001070	E53.8	—	—	—	—	2	2
Aggression	D000374	EFO_0003015	—	—	—	—	—	2	2
Glaucoma	D005901	EFO_0000516	H40	—	—	—	—	2	2

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Thiamine
INN	thiamine
Description	Thiamine(1+) is a primary alcohol that is 1,3-thiazol-3-ium substituted by (4-amino-2-methylpyrimidin-5-yl)methyl, methyl and 2-hydroxyethyl groups at positions 3, 4 and 5, respectively. It has a role as a human metabolite, a Saccharomyces cerevisiae metabolite, an Escherichia coli metabolite and a mouse metabolite. It is a primary alcohol and a vitamin B1. It is a conjugate base of a thiamine(2+).
Classification	Small molecule
Drug class	Vitamin
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1.[Cl-]

Identifiers

PDB	—
CAS-ID	59-43-8
RxCUI	—
ChEMBL ID	CHEMBL1588
ChEBI ID	33283
PubChem CID	1130
DrugBank	DBSALT002650
UNII ID	X66NSO3N35 (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

SLC19A2

SLC19A3

Organism

Homo sapiens

Gene name

SLC19A2

Gene synonyms

THT1, TRMA

NCBI Gene ID

10560

Protein name

thiamine transporter 1

Protein synonyms

high affinity thiamine transporter, reduced folate carrier protein (RFC) like, solute carrier family 19 (thiamine transporter), member 2, Solute carrier family 19 member 2, TC1, Thiamine carrier 1, thiamine-responsive megaloblastic anaemia, thTr-1

Uniprot ID

Q9UN43

Mouse ortholog

Slc19a2 (116914)

thiamine transporter 1 (Q9EQN9)

Variants

No data

Financial

Revenue by drug

€

₣

No data

Estimated US medical usage

Thiamine

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Number of purchases

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Refill frequency

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Price per prescription (USD)

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 61,134 documents

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Safety

Black-box Warning

Black-box warning for: Citranatal 90 dha, Citranatal assure, Citranatal dha, Citranatal essence, Citranatal rx, Enlyte, Healthy mamabe well rounded, Marnatal f, Moms choice rx, Natafort, Nestabs, Nestabs dha, O-cal prenatal vitamin, Pnv prenatal plus multivitamin, Pnv prenatal vitamin, Pnv-select, Pr natal 400, Pr natal 400 ec, Pr natal 430, Pr natal 430 ec, Pre-tabs dha, Prenata, Prenatal plus multivitamin plus dha minicaps, Prenate elite, Select ob, Select-ob plus dha, Tristart dha, Vitafol, Vitafol fe plus, Vitafol ob, Vitafol-ob plus dha

Adverse Events

Top Adverse Reactions

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3,349 adverse events reported

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