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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Commercial
Therapeutic Areas
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 |
|---|---|---|---|---|
| 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 | 2025-05-02 |
| aroamas cot nicotine transdermal patches kit | C200263 | 2025-06-24 |
| atevke quit smoking nicotine | C200263 | 2025-08-11 |
| basic care nicotine | ANDA | 2025-03-24 |
| berkley and jensen nicotine | ANDA | 2025-03-21 |
| berkley and jensen nicotine polacrilex | ANDA | 2017-05-31 |
| bjwc nicotine | ANDA | 2021-09-02 |
| blip | ANDA | 2025-08-11 |
| botasun quit smoking nicotine | C200263 | 2025-06-19 |
| care one nicotine | ANDA | 2025-03-26 |
Show 103 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ulcerative colitis | EFO_0000729 | D003093 | K51 |
| tobacco use disorder | — | D014029 | F17 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
Clinical
Clinical Trials
2536 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 | 87 | 120 | 49 | 65 | 305 | 593 |
| Smoking cessation | D016540 | EFO_0004319 | — | 41 | 52 | 38 | 67 | 264 | 446 |
| Smoking | D012907 | EFO_0004318 | — | 33 | 34 | 21 | 36 | 200 | 309 |
| Cigarette smoking | D000073865 | — | — | 19 | 25 | 6 | 13 | 103 | 159 |
| Tobacco use | D064424 | — | Z72.0 | 8 | 5 | 7 | 3 | 99 | 120 |
| Vaping | D000072137 | — | — | 7 | 6 | 2 | 8 | 86 | 109 |
| Tobacco smoking | D000073869 | — | — | 6 | 5 | 2 | 12 | 83 | 106 |
| Tobacco use cessation | D020340 | — | — | 4 | 10 | 7 | 12 | 50 | 78 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 7 | 12 | 2 | 16 | 32 | 66 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 7 | 4 | 1 | 3 | 51 | 65 |
Show 91 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | 3 | — | 18 | 22 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | — | 1 | — | 12 | 14 |
| Anesthesia | D000758 | — | — | — | — | 1 | — | 13 | 14 |
| Covid-19 | D000086382 | — | U07.1 | — | 3 | 4 | — | 6 | 13 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 2 | 1 | 1 | — | 10 | 13 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 1 | 1 | — | 9 | 12 |
| Harm reduction | D040261 | — | — | 3 | 2 | 3 | — | 5 | 12 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 2 | 1 | — | 9 | 12 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | 2 | — | 10 | 12 |
| Traumatic stress disorders | D040921 | — | — | 2 | 1 | 1 | — | 8 | 11 |
Show 66 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 13 | 2 | — | — | 35 | 49 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 4 | — | — | 22 | 27 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | — | — | 23 | 26 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | 1 | 3 | — | — | 21 | 24 |
| Chronic pain | D059350 | — | — | — | 1 | — | — | 16 | 17 |
| Overweight | D050177 | — | E66.3 | 1 | 3 | — | — | 9 | 12 |
| Psychological distress | D000079225 | — | — | 3 | 1 | — | — | 6 | 9 |
| Cannabis | D002188 | — | — | 4 | 1 | — | — | 2 | 7 |
| Medication adherence | D055118 | EFO_0006344 | — | — | 1 | — | — | 4 | 5 |
| Weight gain | D015430 | — | — | — | 2 | — | — | 3 | 5 |
Show 65 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 2 | — | — | — | 15 | 17 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | 8 | 9 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | 8 | 9 |
| Emergencies | D004630 | — | — | 1 | — | — | — | 8 | 9 |
| Autism spectrum disorder | D000067877 | — | F84.0 | 1 | — | — | — | 5 | 6 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | — | — | — | 4 | 5 |
| Periodontal diseases | D010510 | — | K05.6 | 1 | — | — | — | 4 | 5 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | 1 | — | — | — | 3 | 4 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | 2 | 3 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | — | — | — | 2 | 3 |
Show 25 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acceptance and commitment therapy | D064869 | — | — | — | — | — | — | 10 | 10 |
| Sedentary behavior | D057185 | — | — | — | — | — | — | 9 | 9 |
| Hypoxia | D000860 | — | R09.02 | — | — | — | — | 9 | 9 |
| Apnea | D001049 | — | R06.81 | — | — | — | — | 8 | 8 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 7 | 7 |
| Heart disease risk factors | D000082742 | — | — | — | — | — | — | 7 | 7 |
| Chronic disease | D002908 | — | — | — | — | — | — | 7 | 7 |
| Health behavior | D015438 | — | — | — | — | — | — | 7 | 7 |
| Brain injuries | D001930 | — | S06.9 | — | — | — | — | 6 | 6 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | — | 6 | 6 |
Show 440 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nicotine |
| 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 | Stimulant; Nootropic; Euphoriant |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1CCC[C@H]1c1cccnc1 |
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
No data
Financial
Revenue by drug
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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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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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62,805 adverse events reported
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