Nicotine polacrilex
Nicorette, Nicotine Polacrilex (nicotine polacrilex) is a small molecule pharmaceutical. Nicotine polacrilex was first approved as Nicorette on 1996-02-09. It is used to treat tobacco use disorder and ulcerative colitis in the USA. It is known to target neuronal acetylcholine receptor subunit alpha-4, neuronal acetylcholine receptor subunit alpha-9, neuronal acetylcholine receptor subunit alpha-10, A-type voltage-gated potassium channel KCND3, neuronal acetylcholine receptor subunit alpha-3, and transient receptor potential cation channel subfamily A member 1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Nicorette, Nicotine polacrilex (discontinued: Nicotine polacrilex, Thrive)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nicotine polacrilex
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NICORETTE | GSK | N-018612 OTC | 1996-02-09 | 1 products, RLD |
| NICORETTE (MINT) | GSK | N-018612 OTC | 1998-12-23 | 1 products, RLD |
| NICORETTE | GSK | N-018612 OTC | 2000-09-25 | 1 products, RLD |
| NICORETTE | GSK | N-020066 OTC | 1996-02-09 | 1 products, RLD, RS |
| NICORETTE (MINT) | GSK | N-020066 OTC | 1998-12-23 | 1 products, RLD |
| NICORETTE | GSK | N-020066 OTC | 2000-09-25 | 1 products, RLD |
| NICORETTE | GSK | N-022360 OTC | 2009-05-18 | 2 products, RLD, RS |
| NICORETTE | GSK | N-021330 OTC | 2002-10-31 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amazon basic care nicotine polacrilex | ANDA | 2024-05-16 |
| basic care nicotine | ANDA | 2024-06-12 |
| berkley and jensen nicotine | ANDA | 2023-12-15 |
| berkley and jensen nicotine polacrilex | ANDA | 2017-05-31 |
| bjwc nicotine | ANDA | 2021-09-02 |
| blip | ANDA | 2023-05-02 |
| care one nicotine | ANDA | 2023-10-20 |
| careone mini nicotine polacrilex | ANDA | 2023-10-25 |
| careone nicotine | ANDA | 2024-03-21 |
| co-bb-52549 featuring you hydrating skin enhancing tint spf30-375 strength co-bb-52816 featuring you hydrating skin enhancing tint spf30-390 achiev... | C200263 | 2024-04-01 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ulcerative colitis | EFO_0000729 | D003093 | K51 |
| tobacco use disorder | — | D014029 | F17 |
Agency Specific
FDA
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No data
HCPCS
No data
Clinical
Clinical Trials
2188 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tobacco use disorder | D014029 | — | F17 | 4 | — | 2 | 1 | 13 | 20 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Smoking cessation | D016540 | EFO_0004319 | — | 4 | 2 | 1 | — | 1 | 8 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nicotine polacrilex |
| INN | — |
| Description | (S)-nicotine is a 3-(1-methylpyrrolidin-2-yl)pyridine in which the chiral centre has S-configuration. The naturally occurring and most active enantiomer of nicotine, isolated from Nicotiana tabacum. It has a role as a phytogenic insecticide, a teratogenic agent, a neurotoxin, an anxiolytic drug, a nicotinic acetylcholine receptor agonist, a biomarker, an immunomodulator, a mitogen, a peripheral nervous system drug, a psychotropic drug, a plant metabolite and a xenobiotic. It is a conjugate base of a (S)-nicotinium(1+). It is an enantiomer of a (R)-nicotine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 104062-50-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201536 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | — |
Target
Agency Approved
No data
Alternate
KCND3
KCND3
Organism
Homo sapiens
Gene name
KCND3
Gene synonyms
NCBI Gene ID
Protein name
potassium voltage-gated channel subfamily D member 3
Protein synonyms
potassium channel, voltage gated Shal related subfamily D, member 3, potassium ionic channel Kv4.3, potassium voltage-gated channel long, potassium voltage-gated channel, Shal-related subfamily, member 3, sha1-related potassium channel Kv4.3, voltage-gated K+ channel, Voltage-gated potassium channel subunit Kv4.3
Uniprot ID
Mouse ortholog
Kcnd3 (56543)
potassium voltage-gated channel subfamily D member 3 (Q9Z0V1)
Variants
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Financial
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Trends
PubMed Central
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Safety
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Adverse Events
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47,261 adverse events reported
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