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Drug ReportsNicotine
Nicotine
Habitrol, Nicoderm Cq, Nicotine, Nicotrol (nicotine) is a small molecule pharmaceutical. Nicotine was first approved as Nicotrol on 1996-03-22. It is used to treat tobacco use disorder and ulcerative colitis in the USA. It is known to target transient receptor potential cation channel subfamily A member 1, P2Y purinoceptor 11, hydroxycarboxylic acid receptor 1, neuronal acetylcholine receptor subunit alpha-4, hydroxycarboxylic acid receptor 2, transient receptor potential cation channel subfamily M member 2, A-type voltage-gated potassium channel KCND3, neuronal acetylcholine receptor subunit alpha-9, hydroxycarboxylic acid receptor 3, neuronal acetylcholine receptor subunit alpha-10, and neuronal acetylcholine receptor subunit alpha-3.
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Clinical
Drug
Target
Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
chemically-induced disordersD064419
mental disordersD001523
Trade Name
FDA
EMA
Habitrol, Nicoderm cq, Nicorette, Nicotine, Nicotine polacrilex, Nicotrol (discontinued: Nicotine polacrilex, Nicotrol, Prostep, 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
Nicotine
Tradename
Company
Number
Date
Products
NICODERM CQSanofiN-020165 OTC1996-08-02
3 products, RLD
HABITROLDr Reddys LaboratoriesN-020076 OTC1999-11-12
3 products, RLD, RS
NICOTROLPfizerN-020385 RX1996-03-22
1 products, RLD, RS
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
amazon basic care nicotine polacrilexANDA2025-05-02
aroamas cot nicotine transdermal patchesC2002632024-09-01
aroamas cot nicotine transdermal patches kitC2002632025-06-24
basic care nicotineANDA2025-03-24
berkley and jensen nicotineANDA2025-03-21
berkley and jensen nicotine polacrilexANDA2017-05-31
bjwc nicotineANDA2021-09-02
blipANDA2025-03-17
botasun quit smoking nicotineC2002632025-06-19
care one nicotineANDA2025-03-26
Show 98 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ulcerative colitisEFO_0000729D003093K51
tobacco use disorder—D014029F17
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
Code
Description
S4990
Nicotine patches, legend
S4991
Nicotine patches, non-legend
Clinical
Clinical Trials
2476 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—F17861194964294579
Smoking cessationD016540EFO_0004319—39503566253428
SmokingD012907EFO_0004318—28302034194293
Cigarette smokingD000073865——192451399153
Tobacco useD064424—Z72.0857296116
Tobacco smokingD000073869——5521180101
VapingD000072137——76177596
Tobacco use cessationD020340——4107115077
SchizophreniaD012559EFO_0000692F207122163064
Substance-related disordersD019966EFO_0003890F1363135063
Show 93 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920EFO_0000400E08-E13—13—1721
StrokeD020521EFO_0000712I63.91—1—1214
Covid-19D000086382—U07.1—34—714
Post-traumatic stress disordersD013313EFO_0001358F43.1211—1013
AnesthesiaD000758————1—1213
Lung diseasesD008171EFO_0003818J98.4112—812
AsthmaD001249EFO_0000270J45—21—912
Wounds and injuriesD014947—T14.8——2—1012
SyndromeD013577——121—811
Traumatic stress disordersD040921——211—811
Show 71 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———142——3348
ObesityD009765EFO_0001073E66.914——2227
Breast neoplasmsD001943EFO_0003869C5012——2326
AnxietyD001007EFO_0005230F41.113——2124
Chronic painD059350———1——1617
OverweightD050177—E66.3—2——911
Psychological distressD000079225——31——69
CannabisD002188——41——27
Communicable diseasesD003141———1——56
Alcohol-related disordersD019973—F10—2——24
Show 61 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Anxiety disordersD001008EFO_0006788F41.12———1416
CarcinomaD002277—C80.01———910
Prostatic neoplasmsD011471—C611———89
EmergenciesD004630——1———89
HemorrhageD006470MP_0001914R581———67
Autism spectrum disorderD000067877—F84.01———56
Periodontal diseasesD010510—K05.61———45
PeriodontitisD010518EFO_0000649K05.31———34
AggressionD000374EFO_0003015—1———34
Autistic disorderD001321EFO_0003758F84.01———34
Show 29 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acceptance and commitment therapyD064869——————1010
Sedentary behaviorD057185——————99
HypoxiaD000860—R09.02————88
ApneaD001049—R06.81————88
Heart failureD006333EFO_0003144I50————77
Chronic diseaseD002908——————77
Health behaviorD015438——————77
Brain injuriesD001930—S06.9————66
Suicidal ideationD059020EFO_0004320R45.851————66
Heart disease risk factorsD000082742——————55
Show 425 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNicotine
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 classStimulant; Nootropic; Euphoriant
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN1CCC[C@H]1c1cccnc1
Identifiers
PDB—
CAS-ID54-11-5
RxCUI—
ChEMBL IDCHEMBL3
ChEBI ID17688
PubChem CID89594
DrugBankDB00184
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
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Nicotine
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 120,450 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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48,197 adverse events reported
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