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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
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update 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)
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 743 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
639 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DyslipidemiasD050171HP_0003119—641315745
Healthy volunteers/patients———203—11236
HypercholesterolemiaD006937HP_0003124—42173531
HyperlipidemiasD006949HP_0003077E78.551106426
Type 2 diabetes mellitusD003924EFO_0001360E117643524
Cardiovascular diseasesD002318HP_0001626—13101822
Diabetes mellitusD003920HP_0000819E08-E135472522
AtherosclerosisD050197EFO_0003914I25.1—256821
HyperlipoproteinemiasD006951HP_0010980———105116
ObesityD009765EFO_0001073E66.944—2816
Show 66 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C801071—117
LeukemiaD007938—C95382——11
Cognitive dysfunctionD060825HP_0001268G31.84321—611
Hiv infectionsD015658EFO_0000764B20—24—39
Myeloid leukemiaD007951—C92262——9
Acute kidney injuryD058186HP_0001919N17132—39
GlaucomaD005901EFO_0000516H40—12—68
Parkinson diseaseD010300EFO_0002508G20—21—47
Myocardial infarctionD009203EFO_0000612I21—12—36
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—151——6
Show 93 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845—33——813
Heart failureD006333HP_0001635I5035——29
Metabolic diseasesD008659EFO_0000589E88.942——39
Breast neoplasmsD001943EFO_0003869C5025——17
Glucose metabolism disordersD044882——32——27
Alzheimer diseaseD000544EFO_0000249F0335——17
Fatty liverD005234EFO_0003934——4——26
AtaxiaD001259—R27.0—3——25
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81—4——15
Cerebellar ataxiaD002524HP_0001251——3——14
Show 91 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599——3———14
Non-hodgkin lymphomaD008228—C85.93————3
Abdominal obesityD056128HP_0001956—1———23
Glucose intoleranceD018149HP_0000833R73.031———23
Prediabetic stateD011236EFO_1001121R73.031———23
LymphomaD008223—C85.92————2
Colorectal neoplasmsD015179——1———12
Obsessive-compulsive disorderD009771EFO_0004242F421———12
Pregnancy-induced hypertensionD046110—O131———12
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.91———12
Show 39 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DermatitisD003872HP_0011123L30.9————44
Diet therapyD004035——————33
Dietary supplementsD019587——————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 120 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 13,770 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, Tricare prenatal, Vitafol, Vitafol fe plus
Adverse Events
Top Adverse Reactions
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1,773 adverse events reported
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