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Drug ReportsNicotine polacrilex
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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Financial
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1M
3M
6M
YTD
1Y
2Y
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
chemically-induced disordersD064419
mental disordersD001523
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
NICORETTEGSKN-018612 OTC1996-02-09
1 products, RLD
NICORETTE (MINT)GSKN-018612 OTC1998-12-23
1 products, RLD
NICORETTEGSKN-018612 OTC2000-09-25
1 products, RLD
NICORETTEGSKN-020066 OTC1996-02-09
1 products, RLD, RS
NICORETTE (MINT)GSKN-020066 OTC1998-12-23
1 products, RLD
NICORETTEGSKN-020066 OTC2000-09-25
1 products, RLD
NICORETTEGSKN-022360 OTC2009-05-18
2 products, RLD, RS
NICORETTEGSKN-021330 OTC2002-10-31
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
amazon basic care nicotine polacrilexANDA2024-05-16
basic care nicotineANDA2024-06-12
berkley and jensen nicotineANDA2023-12-15
berkley and jensen nicotine polacrilexANDA2017-05-31
bjwc nicotineANDA2021-09-02
blipANDA2023-05-02
care one nicotineANDA2023-10-20
careone mini nicotine polacrilexANDA2023-10-25
careone nicotineANDA2024-03-21
co-bb-52549 featuring you hydrating skin enhancing tint spf30-375 strength co-bb-52816 featuring you hydrating skin enhancing tint spf30-390 achiev...C2002632024-04-01
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ulcerative colitisEFO_0000729D003093K51
tobacco use disorder—D014029F17
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Nicotine Polacrilex, Nicorette, Haleon Us Holdings
85011642029-06-14DP
89407722029-04-30DP
83236832028-04-30
ATC Codes
N: Nervous system drugs
— N07: Other nervous system drugs in atc
— N07B: Drugs used in addictive disorders
— N07BA: Drugs used in nicotine dependence
— N07BA01: Nicotine
HCPCS
No data
Clinical
Clinical Trials
2344 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 disorderD014029—F17861184963286569
Smoking cessationD016540EFO_0004319—37493566241414
SmokingD012907EFO_0004318—27302034186284
Cigarette smokingD000073865——192451296149
Tobacco useD064424——858289110
Tobacco smokingD000073869——552107999
VapingD000072137——76176788
Tobacco use cessationD020340——4107115077
SchizophreniaD012559EFO_0000692F207122162862
Substance-related disordersD019966EFO_0003890F1363134457
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnxietyD001007EFO_0005230F41.1131—1922
Diabetes mellitusD003920HP_0000819E08-E13——1—1516
Covid-19D000086382———34—815
Post-traumatic stress disordersD013313EFO_0001358F43.1211—1013
AnesthesiaD000758————1—1213
Lung diseasesD008171HP_0002088J98.4112—812
StrokeD020521EFO_0000712I63.91—1—1012
AsthmaD001249EFO_0000270J45—21—912
Traumatic stress disordersD040921——211—811
Wounds and injuriesD014947—T14.8——2—911
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———132——2943
ObesityD009765EFO_0001073E66.914——2126
Breast neoplasmsD001943EFO_0003869C5012——2124
Chronic painD059350HP_0012532——1——1415
OverweightD050177—E66.3—2——911
Psychological distressD000079225——31——69
InflammationD007249MP_0001845—21——47
Communicable diseasesD003141———1——56
CannabisD002188——41——16
Alcohol-related disordersD019973—F10—2——24
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Anxiety disordersD001008EFO_0006788F41.12———1113
CarcinomaD002277—C80.01———910
Prostatic neoplasmsD011471—C611———89
EmergenciesD004630——1———89
Periodontal diseasesD010510—K05.61———45
Autism spectrum disorderD000067877HP_0000729F84.01———45
PeriodontitisD010518EFO_0000649K05.31———34
AggressionD000374EFO_0003015—1———34
Squamous cell carcinoma of head and neckD000077195——1———23
Squamous cell carcinomaD002294——1———23
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SuicideD013405——————88
ApneaD001049HP_0002104R06.81————88
Heart failureD006333HP_0001635I50————77
Acceptance and commitment therapyD064869——————77
Chronic diseaseD002908——————77
Chronic renal insufficiencyD051436—N18————77
Sedentary behaviorD057185——————66
HemorrhageD006470MP_0001914R58————66
HypoxiaD000860HP_0012418R09.02————66
Heart disease risk factorsD000082742——————55
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNicotine 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)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID104062-50-2
RxCUI—
ChEMBL IDCHEMBL1201536
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
3752
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
Q9UK17
Mouse ortholog
Kcnd3 (56543)
potassium voltage-gated channel subfamily D member 3 (Q9Z0V1)
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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26,401 adverse events reported
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