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Drug ReportsNiacinamide
Niacinamide
Berocca Pn, Infuvite, M.v.c. 9+, M.v.i, M.v.i. Lyophilized, Mvc, Tpn, Vitaped (niacinamide) is a small molecule pharmaceutical. Niacinamide was first approved as Tpn on 1982-01-01. It is used to treat hypercholesterolemia, hypertriglyceridemia, pellagra, and peripheral vascular diseases in the USA.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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
cardiovascular diseasesD002318
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Combinations
Infuvite (discontinued: Berocca pn, M.v.c. 9+, M.v.i., M.v.i. lyophilized, Mvc, Tpn, Vitaped)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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 ADULTSandozN-021163 RX2000-05-18
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 (PHARMACY BULK PACKAGE)SandozN-021265 RX2004-01-29
1 products, RLD, RS
INFUVITE PEDIATRICSandozN-021265 RX2001-02-21
1 products, RLD, RS
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. PEDIATRICHospiraN-018920 DISCN2000-09-21
1 products, RLD
Hide discontinued
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 LYOPHILIZEDTeligentN-018933 DISCN1985-08-08
1 products
Hide discontinued
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 ADULTHospiraN-008809 DISCN2004-04-22
1 products
Hide discontinued
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+3APP PharmaceuticalsN-018440 DISCN1985-08-08
1 products
M.V.I.-12 ADULTHospiraN-008809 DISCN1985-08-08
2 products
MVC PLUSAllerganN-018439 DISCN1985-08-08
1 products
Hide discontinued
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. ADULTHospiraN-021625 DISCN2004-01-30
1 products, RLD
M.V.I. ADULT (PHARMACY BULK PACKAGE)HospiraN-021643 DISCN2004-02-18
1 products, RLD
Hide discontinued
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 PNRocheN-006071 DISCN1985-10-10
1 products
Hide discontinued
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pantothenic acid
+
Phytonadione
+
Pyridoxine
+
Riboflavin
+
Thiamine
+
Vitamin a palmitate
+
Vitamin e
Tradename
Company
Number
Date
Products
VITAPEDHospiraN-020176 DISCN1993-12-29
1 products
Hide discontinued
Niacinamide
+
Pyridoxine hydrochloride
+
Tyrosine
Tradename
Company
Number
Date
Products
TPNInternational MineralsN-008378 DISCN1982-01-01
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
011503 dapsone 6% / niacinamide 2% / spironolactone 5%unapproved drug other2020-07-02
011504 dapsone 8.5% / niacinamide 4%unapproved drug other2020-07-02
071023 econazole nitrate 1% / niacinamide 4%unapproved drug other2020-07-02
574h cell careunapproved drug other2020-06-19
a.munapproved drug other2021-04-24
aape continuous renewalunapproved drug other2019-08-26
aape continuous renewal eyeunapproved drug other2019-08-26
aape continuous renewal serumunapproved drug other2019-08-26
abalone aqua flood waterunapproved drug other2017-02-20
abalone crystaldouble exunapproved drug other2017-02-23
Show 514 more
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A11: Vitamins
— A11H: Other plain vitamin preparations in atc
— A11HA: Other plain vitamin preparations in atc
— A11HA01: Nicotinamide
HCPCS
No data
Clinical
Clinical Trials
612 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———192—11032
DyslipidemiasD050171HP_0003119—63612532
HypercholesterolemiaD006937HP_0003124—32153427
Type 2 diabetes mellitusD003924EFO_0001360E117543422
HyperlipidemiasD006949HP_0003077E78.54164419
AtherosclerosisD050197EFO_0003914I25.1—145616
AgingD000375GO_0007568R41.8136—1614
ObesityD009765EFO_0001073E66.943—2613
Coronary diseaseD003327———163212
Covid-19D000086382—U07.11621412
Show 40 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318HP_0001626—1310—720
NeoplasmsD009369—C801041——13
AnemiaD000740HP_0001903D64.9——2—911
Heart diseasesD006331EFO_0003777I51.9—16—310
Hiv infectionsD015658EFO_0000764B20—24—39
Cognitive dysfunctionD060825HP_0001268G31.84221—59
MalnutritionD044342EFO_0008572E40-E46—21—57
SchizophreniaD012559EFO_0000692F20—22—57
Diabetes mellitusD003920HP_0000819E08-E133—2—27
Parkinson diseaseD010300EFO_0002508G20—21—47
Show 49 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333HP_0001635I5023——27
Glucose metabolism disordersD044882——32——27
Breast neoplasmsD001943EFO_0003869C5025———6
InflammationD007249MP_0001845—21——46
Alzheimer diseaseD000544EFO_0000249F0314——15
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81—3——14
Amyotrophic lateral sclerosisD000690HP_0007354G12.21—1——34
Mitochondrial myopathiesD017240Orphanet_206966G71.3—1——34
Systolic heart failureD054143EFO_1001207I50.2022———3
AnxietyD001007EFO_0005230F41.111——23
Show 55 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.93————3
Birth weightD001724EFO_0004344—1———12
MelanosisD008548HP_0001480L81.11———12
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.91———12
PharmacokineticsD010599——2————2
Follicular lymphomaD008224—C821————1
Mantle-cell lymphomaD020522—C83.11————1
Waldenstrom macroglobulinemiaD008258HP_0005508C88.01————1
Large b-cell lymphoma diffuseD016403—C83.31————1
Colorectal neoplasmsD015179——1————1
Show 21 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Iron deficienciesD000090463—E61.1————44
Diet therapyD004035——————33
OverweightD050177—E66.3————33
GlaucomaD005901EFO_0000516H40————33
Cerebral palsyD002547—G80————22
ArthritisD001168HP_0001369M05-M14————22
FibromyalgiaD005356EFO_0005687M79.1————22
Male infertilityD007248EFO_0004248N46————22
Respiratory tract infectionsD012141—J06.9————22
CognitionD003071EFO_0003925—————22
Show 76 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNiacinamide
INNnicotinamide
Description
Nicotinamide is a pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group. It has a role as an EC 2.4.2.30 (NAD(+) ADP-ribosyltransferase) inhibitor, a metabolite, a cofactor, an antioxidant, a neuroprotective agent, an EC 3.5.1.98 (histone deacetylase) inhibitor, an anti-inflammatory agent, a Sir2 inhibitor, a Saccharomyces cerevisiae metabolite, an Escherichia coli metabolite, a mouse metabolite, a human urinary metabolite and a geroprotector. It is a vitamin B3, a pyridinecarboxamide and a pyridine alkaloid. It is functionally related to a nicotinic acid.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
NC(=O)c1cccnc1
Identifiers
PDB—
CAS-ID98-92-0
RxCUI—
ChEMBL IDCHEMBL1140
ChEBI ID17154
PubChem CID936
DrugBankDB02701
UNII ID25X51I8RD4 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Niacinamide
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 107,465 documents
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Safety
Black-box Warning
Black-box warning for: Citranatal 90 dha, Citranatal assure, Citranatal dha, Citranatal essence, Citranatal rx, Marnatal f, Moms choice rx, Natafort, Neonatal complete, Neonatal dha, Neonatal19, Nestabs, Nestabs dha, 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, Primacare, Select ob, Select-ob plus dha, Vitafol, Vitafol fe plus
Adverse Events
Top Adverse Reactions
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1,138 adverse events reported
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