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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
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Completion 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)
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
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 PEDIATRICSandozN-021265 RX2001-02-21
1 products, RLD, RS
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)SandozN-021265 RX2004-01-29
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+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
+
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
+
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 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
+
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
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
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
011010 niacinamide 4% / tretinoin 0.025%unapproved drug other2020-07-02
011013 niacinamide 4% / tretinoin 0.025%unapproved drug other2020-07-02
011020 niacinamide 4% / tretinoin 0.05%unapproved drug other2020-07-02
011021 niacinamide 4% / tretinoin 0.05%unapproved drug other2020-07-02
011054 niacinamide 4% / spironolactone 5%unapproved drug other2020-07-02
011218 niacinamide 2% / spironolactone 5% / tretinoin 0.025%unapproved drug other2020-07-02
011220 niacinamide 2% / spironolactone 5% / tretinoin 0.05%unapproved drug other2020-07-02
011312 niacinamide 4% / tazarotene 0.05%unapproved drug other2020-07-02
011503 dapsone 6% / niacinamide 2% / spironolactone 5%unapproved drug other2020-07-02
011504 dapsone 8.5% / niacinamide 4%unapproved drug other2020-07-02
Show 730 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypercholesterolemia—D006937—
hypophosphatemiaHP_0002148D017674—
hypertriglyceridemiaEFO_0004211D015228—
peripheral vascular diseasesEFO_0003875D016491I73.9
dermatitis—D003872L30.9
alcoholic neuropathyEFO_1000803D020269G62.1
common coldEFO_0007214D003139J00
seizures—D012640G40.4
vitamin a deficiencyEFO_1001237D014802E50
hypoparathyroidism—D007011E20
Show 27 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
656 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DyslipidemiasD050171——641315745
Healthy volunteers/patients———213—11237
HypercholesterolemiaD006937——42173531
HyperlipidemiasD006949EFO_0003774E78.551106426
Type 2 diabetes mellitusD003924EFO_0001360E117643524
Cardiovascular diseasesD002318EFO_0000319I98121011023
Diabetes mellitusD003920EFO_0000400E08-E135472522
AtherosclerosisD050197EFO_0003914I25.1—256922
ObesityD009765EFO_0001073E66.944—2816
HypertensionD006973EFO_0000537I105252115
Show 68 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C801071—117
Hiv infectionsD015658EFO_0000764B20—24—511
Cognitive dysfunctionD060825—G31.84321—611
LeukemiaD007938—C95371——9
Acute kidney injuryD058186—N17132—39
GlaucomaD005901EFO_0000516H40—13—69
Myeloid leukemiaD007951—C92251——7
Parkinson diseaseD010300EFO_0002508G20—21—47
Myocardial infarctionD009203EFO_0000612I21—12—36
TuberculosisD014376EFO_0000774A15-A191—5——6
Show 94 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845—33——914
Metabolic diseasesD008659EFO_0000589E88.942——410
Heart failureD006333EFO_0003144I5035——29
Breast neoplasmsD001943EFO_0003869C5025——17
Glucose metabolism disordersD044882——32——27
Alzheimer diseaseD000544EFO_0000249F0335——17
Fatty liverD005234EFO_0003934—14——26
AtaxiaD001259—R27.0—3——25
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81—3——25
Non-hodgkin lymphomaD008228—C85.941———4
Show 100 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599——3———14
Abdominal obesityD056128——1———23
Glucose intoleranceD018149HP_0000833R73.031———23
Prediabetic stateD011236EFO_1001121R73.031———23
Colorectal neoplasmsD015179——1———12
Obsessive-compulsive disorderD009771EFO_0004242F421———12
Pregnancy-induced hypertensionD046110—O131———12
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.91———12
Irritable bowel syndromeD043183EFO_0000555K581———12
Follicular lymphomaD008224—C821————1
Show 37 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DermatitisD003872—L30.9————44
Healthy agingD000073656——————44
Diet therapyD004035——————33
CognitionD003071EFO_0003925—————33
OverweightD050177—E66.3————33
Atopic dermatitisD003876EFO_0000274L20————33
Cerebral palsyD002547—G80————22
FibromyalgiaD005356EFO_0005687M79.1————22
Impulsive behaviorD007175——————22
Primary ovarian insufficiencyD016649EFO_0004266E28.3————22
Show 116 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 19,684 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, 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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2,129 adverse events reported
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