Niacin
Niacin, Niacor (niacin) is a small molecule pharmaceutical. Niacin was first approved as Wampocap on 1982-01-01. It is used to treat hypercholesterolemia, hypertriglyceridemia, pellagra, and peripheral vascular diseases in the USA. It is known to target hydroxycarboxylic acid receptor 1, hydroxycarboxylic acid receptor 2, and hydroxycarboxylic acid receptor 3.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 011010 niacinamide 4% / tretinoin 0.025% | unapproved drug other | 2020-07-02 |
| 011013 niacinamide 4% / tretinoin 0.025% | unapproved drug other | 2020-07-02 |
| 011020 niacinamide 4% / tretinoin 0.05% | unapproved drug other | 2020-07-02 |
| 011021 niacinamide 4% / tretinoin 0.05% | unapproved drug other | 2020-07-02 |
| 011054 niacinamide 4% / spironolactone 5% | unapproved drug other | 2020-07-02 |
| 011218 niacinamide 2% / spironolactone 5% / tretinoin 0.025% | unapproved drug other | 2020-07-02 |
| 011220 niacinamide 2% / spironolactone 5% / tretinoin 0.05% | unapproved drug other | 2020-07-02 |
| 011312 niacinamide 4% / tazarotene 0.05% | unapproved drug other | 2020-07-02 |
| 011503 dapsone 6% / niacinamide 2% / spironolactone 5% | unapproved drug other | 2020-07-02 |
| 011504 dapsone 8.5% / niacinamide 4% | unapproved drug other | 2020-07-02 |
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
C: Cardiovascular system drugs
— C04: Peripheral vasodilators
— C04A: Peripheral vasodilators
— C04AC: Nicotinic acid and derivatives, peripheral vasodilators
— C04AC01: Nicotinic acid
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AD: Nicotinic acid and derivatives, lipid modifying, plain
— C10AD02: Nicotinic acid
— C10AD52: Nicotinic acid, combinations
— C10B: Lipid modifying agents, combinations
— C10BA: Combinations of various lipid modifying agents
— C10BA01: Lovastatin and nicotinic acid
HCPCS
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Clinical
Clinical Trials
688 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | — | — | 6 | 4 | 14 | 15 | 7 | 46 |
| Healthy volunteers/patients | — | — | — | 24 | 3 | — | 1 | 12 | 40 |
| Hypercholesterolemia | D006937 | — | — | 4 | 2 | 17 | 3 | 5 | 31 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 5 | 1 | 10 | 6 | 4 | 26 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 7 | 6 | 4 | 3 | 5 | 24 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | 2 | 10 | 1 | 10 | 23 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 2 | 5 | 6 | 10 | 23 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 5 | 4 | 7 | 2 | 5 | 22 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 5 | 2 | 3 | 5 | 5 | 20 |
| Hypertension | D006973 | EFO_0000537 | I10 | 5 | 2 | 5 | 2 | 2 | 16 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 10 | 7 | 1 | — | 1 | 17 |
| Cognitive dysfunction | D060825 | — | G31.84 | 3 | 3 | 1 | — | 6 | 12 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | 4 | — | 5 | 11 |
| Leukemia | D007938 | — | C95 | 3 | 7 | 1 | — | — | 9 |
| Acute kidney injury | D058186 | — | N17 | 1 | 3 | 2 | — | 3 | 9 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | 1 | 3 | — | 6 | 9 |
| Myeloid leukemia | D007951 | — | C92 | 2 | 5 | 1 | — | — | 7 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | 1 | — | 4 | 7 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | 2 | — | 3 | 6 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | — | 5 | — | — | 6 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | 3 | 3 | — | — | 10 | 15 |
| Heart failure | D006333 | EFO_0003144 | I50 | 3 | 5 | — | — | 3 | 10 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 4 | 2 | — | — | 4 | 10 |
| Glucose metabolism disorders | D044882 | — | — | 3 | 2 | — | — | 2 | 7 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 3 | 5 | — | — | 1 | 7 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 5 | — | — | — | 6 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | 4 | — | — | 2 | 6 |
| Ataxia | D001259 | — | R27.0 | — | 3 | — | — | 2 | 5 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 3 | — | — | 2 | 5 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | 1 | 2 | — | — | 3 | 5 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | 1 | 4 |
| Abdominal obesity | D056128 | — | — | 1 | — | — | — | 2 | 3 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | 1 | — | — | — | 2 | 3 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | 1 | — | — | — | 2 | 3 |
| Colorectal neoplasms | D015179 | — | — | 1 | — | — | — | 1 | 2 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | 1 | — | — | — | 1 | 2 |
| Pregnancy-induced hypertension | D046110 | — | O13 | 1 | — | — | — | 1 | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | 1 | 2 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | 1 | — | — | — | 1 | 2 |
| Follicular lymphoma | D008224 | — | C82 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dermatitis | D003872 | — | L30.9 | — | — | — | — | 4 | 4 |
| Healthy aging | D000073656 | — | — | — | — | — | — | 4 | 4 |
| Diet therapy | D004035 | — | — | — | — | — | — | 3 | 3 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 3 | 3 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | — | 3 | 3 |
| Overweight | D050177 | — | E66.3 | — | — | — | — | 3 | 3 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 3 | 3 |
| Cerebral palsy | D002547 | — | G80 | — | — | — | — | 2 | 2 |
| Headache | D006261 | — | R51 | — | — | — | — | 2 | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Niacin |
| INN | nicotinic acid |
| Description | Nicotinic acid is a pyridinemonocarboxylic acid that is pyridine in which the hydrogen at position 3 is replaced by a carboxy group. It has a role as an antidote, an antilipemic drug, a vasodilator agent, a metabolite, an EC 3.5.1.19 (nicotinamidase) inhibitor, an Escherichia coli metabolite, a mouse metabolite, a human urinary metabolite and a plant metabolite. It is a vitamin B3, a pyridinemonocarboxylic acid and a pyridine alkaloid. It is a conjugate acid of a nicotinate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)c1cccnc1 |
Identifiers
| PDB | — |
| CAS-ID | 59-67-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL573 |
| ChEBI ID | 15940 |
| PubChem CID | 938 |
| DrugBank | DB00627 |
| UNII ID | 2679MF687A (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CA2
CA2
Organism
Homo sapiens
Gene name
CA2
Gene synonyms
NCBI Gene ID
Protein name
carbonic anhydrase 2
Protein synonyms
CA-II, CAC, Carbonate dehydratase II, carbonic anhydrase B, Carbonic anhydrase C, Carbonic anhydrase II, carbonic dehydratase, Cyanamide hydratase CA2, epididymis luminal protein 76, epididymis secretory protein Li 282
Uniprot ID
Mouse ortholog
Car2 (12349)
carbonic anhydrase 2 (Q9DCY9)
Variants
No data
Financial
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Niaspan – AbbVie
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Estimated US medical usage
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Trends
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Safety
Black-box Warning
Black-box warning for: Citranatal 90 dha, Citranatal assure, Citranatal dha, Citranatal essence, Citranatal rx, 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, Primacare, 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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302 adverse events reported
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