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, Nicotine, Nicotrol (discontinued: Nicotrol, Prostep)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amazon basic care nicotine polacrilex | ANDA | 2024-05-16 |
| aroamas cot nicotine transdermal patches | C200263 | 2024-09-01 |
| 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 |
Show 86 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
2167 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 | 86 | 118 | 49 | 63 | 286 | 569 |
| Smoking cessation | D016540 | EFO_0004319 | — | 37 | 49 | 35 | 66 | 240 | 413 |
| Smoking | D012907 | EFO_0004318 | — | 27 | 30 | 20 | 34 | 186 | 284 |
| Cigarette smoking | D000073865 | — | — | 19 | 24 | 5 | 12 | 96 | 149 |
| Tobacco use | D064424 | — | — | 8 | 5 | 8 | 2 | 89 | 110 |
| Tobacco smoking | D000073869 | — | — | 5 | 5 | 2 | 10 | 79 | 99 |
| Vaping | D000072137 | — | — | 7 | 6 | 1 | 7 | 67 | 88 |
| Tobacco use cessation | D020340 | — | — | 4 | 10 | 7 | 11 | 50 | 77 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 7 | 12 | 2 | 16 | 28 | 62 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 6 | 3 | 1 | 3 | 44 | 57 |
Show 82 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety | D001007 | EFO_0005230 | F41.1 | 1 | 3 | 1 | — | 17 | 20 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | 2 | — | 13 | 16 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 2 | 1 | 1 | — | 10 | 13 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 2 | 1 | — | 9 | 12 |
| Anesthesia | D000758 | — | — | — | — | 1 | — | 11 | 12 |
| Traumatic stress disorders | D040921 | — | — | 2 | 1 | 1 | — | 8 | 11 |
| Harm reduction | D040261 | — | — | 3 | 1 | 3 | — | 3 | 9 |
| Syndrome | D013577 | — | — | 1 | 1 | 1 | — | 6 | 8 |
| Smoking reduction | D000074264 | — | — | 1 | — | 1 | — | 6 | 8 |
| Covid-19 | D000086382 | — | — | — | — | 3 | — | 5 | 8 |
Show 40 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 14 | 1 | — | — | 26 | 40 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 4 | — | — | 20 | 25 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | — | — | 19 | 22 |
| Chronic pain | D059350 | HP_0012532 | — | — | 1 | — | — | 14 | 15 |
| Overweight | D050177 | — | E66.3 | — | 2 | — | — | 9 | 11 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | 8 | 9 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | 1 | — | — | 8 | 9 |
| Psychological distress | D000079225 | — | — | 3 | 1 | — | — | 6 | 9 |
| Cannabis | D002188 | — | — | 4 | 1 | — | — | 1 | 6 |
| Alcohol-related disorders | D019973 | — | F10 | — | 2 | — | — | 2 | 4 |
Show 47 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 | — | — | — | 10 | 12 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | 8 | 9 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | — | — | — | 8 | 9 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | 6 | 7 |
| Emergencies | D004630 | — | — | 1 | — | — | — | 4 | 5 |
| Periodontal diseases | D010510 | — | K05.6 | 1 | — | — | — | 4 | 5 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | 1 | — | — | — | 4 | 5 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | — | — | — | 3 | 4 |
| Aggression | D000374 | EFO_0003015 | — | 1 | — | — | — | 3 | 4 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | 2 | 3 |
Show 27 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 11 | 11 |
| Acceptance and commitment therapy | D064869 | — | — | — | — | — | — | 7 | 7 |
| Chronic disease | D002908 | — | — | — | — | — | — | 7 | 7 |
| Suicide | D013405 | — | — | — | — | — | — | 7 | 7 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 7 | 7 |
| Apnea | D001049 | HP_0002104 | R06.81 | — | — | — | — | 7 | 7 |
| Sedentary behavior | D057185 | — | — | — | — | — | — | 6 | 6 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 5 | 5 |
| Heart disease risk factors | D000082742 | — | — | — | — | — | — | 5 | 5 |
| Health behavior | D015438 | — | — | — | — | — | — | 5 | 5 |
Show 318 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 | — |
| 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
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Estimated US medical usage
Nicotine
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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46,477 adverse events reported
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