Chantix, Champix(varenicline)
Champix, Tyrvaya (varenicline) is a small molecule pharmaceutical. Varenicline was first approved as Chantix on 2006-05-10. It has been approved in Europe to treat tobacco use cessation. The pharmaceutical is active against neuronal acetylcholine receptor subunit alpha-4. In addition, it is known to target neuronal acetylcholine receptor subunit alpha-3.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| behavior and behavior mechanisms | D001520 |
Trade Name
FDA
EMA
Tyrvaya (generic drugs available since 2021-08-11, discontinued: Chantix)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Varenicline tartrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TYRVAYA | Oyster Point Pharma | N-213978 RX | 2021-10-15 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| chantix | New Drug Application | 2021-07-12 |
| tyrvaya | New Drug Application | 2021-10-20 |
| varenicline | ANDA | 2023-06-16 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
VARENICLINE TARTRATE, TYRVAYA, OYSTER POINT PHARMA | |||
| 2024-10-15 | NP | ||
HCPCS
No data
Clinical
Clinical Trials
309 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Smoking cessation | D016540 | EFO_0004319 | 13 | 18 | 27 | 38 | 19 | 109 | |
| Tobacco use disorder | D014029 | F17 | 6 | 21 | 21 | 20 | 21 | 81 | |
| Smoking | D012907 | EFO_0003768 | F17 | 4 | 12 | 8 | 12 | 8 | 38 |
| Cigarette smoking | D000073865 | 5 | 6 | 2 | 5 | 2 | 18 | ||
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 2 | 11 | 2 | 2 | 1 | 16 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 5 | 1 | 9 | — | 15 |
| Dry eye syndromes | D015352 | H04.12 | 1 | 4 | 4 | 3 | — | 12 | |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 3 | 3 | — | 2 | 2 | 10 |
| Tobacco use cessation | D020340 | — | 2 | 2 | 4 | 2 | 9 | ||
| Hiv | D006678 | O98.7 | — | — | 2 | 4 | 2 | 8 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tobacco use | D064424 | Z72.0 | — | — | 1 | — | 3 | 4 | |
| Lung neoplasms | D008175 | C34.90 | 2 | 1 | 1 | — | 1 | 4 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 2 | — | 1 | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 2 | 1 | — | — | 2 |
| Harm reduction | D040261 | — | 1 | 1 | — | — | 1 | ||
| Disease progression | D018450 | — | — | 1 | — | — | 1 | ||
| Habits | D006184 | — | 1 | 1 | — | — | 1 | ||
| Friedreich ataxia | D005621 | Orphanet_95 | G11.11 | — | 1 | 1 | — | — | 1 |
| Smoking reduction | D000074264 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | F14 | — | 5 | — | — | 1 | 6 | |
| Second primary neoplasms | D016609 | — | 1 | — | — | — | 1 | ||
| Weight gain | D015430 | HP_0004324 | 1 | 1 | — | — | — | 1 | |
| Machado-joseph disease | D017827 | EFO_0004135 | — | 1 | — | — | — | 1 | |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 4 | — | — | — | — | 4 | ||
| Head and neck neoplasms | D006258 | 2 | — | — | — | 1 | 3 | ||
| Squamous cell carcinoma of head and neck | D000077195 | 1 | — | — | — | 1 | 2 | ||
| Pharmacokinetics | D010599 | 2 | — | — | — | — | 2 | ||
| Cognition | D003071 | EFO_0003925 | 1 | — | — | — | — | 1 | |
| Nasopharyngeal neoplasms | D009303 | 1 | — | — | — | — | 1 | ||
| Chronic pain | D059350 | HP_0012532 | 1 | — | — | — | — | 1 | |
| Biological availability | D001682 | 1 | — | — | — | — | 1 | ||
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | — | — | — | — | 2 | 2 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 2 | 2 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 2 | 2 |
| Sleep | D012890 | GO_0030431 | — | — | — | — | 1 | 1 | |
| Non-small-cell lung carcinoma | D002289 | — | — | — | — | 1 | 1 | ||
| Health behavior | D015438 | — | — | — | — | 1 | 1 | ||
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | — | — | — | 1 | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 1 | 1 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 1 | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | VARENICLINE |
| INN | varenicline |
| Description | Varenicline, sold under the brand names Chantix and Champix among others, is a medication used for smoking cessation and for the treatment of dry eye disease. It is a nicotinic receptor partial agonist and a cholinergic agonist. When activated, this receptor releases dopamine in the nucleus accumbens, the brain's reward center, thereby reducing cravings and withdrawal symptoms associated with smoking cessation.
|
| Classification | Small molecule |
| Drug class | nicotinic acetylcholine receptor partial agonists/agonists |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | c1cnc2cc3c(cc2n1)C1CNCC3C1 |
Identifiers
| PDB | 5AIN |
| CAS-ID | 249296-44-4 |
| RxCUI | 591622 |
| ChEMBL ID | CHEMBL1396 |
| ChEBI ID | — |
| PubChem CID | 170361 |
| DrugBank | DB01273 |
| UNII ID | W6HS99O8ZO (ChemIDplus, GSRS) |
Target
Agency Approved
CHRNA4
CHRNA4
Organism
Homo sapiens
Gene name
CHRNA4
Gene synonyms
NACRA4
NCBI Gene ID
Protein name
neuronal acetylcholine receptor subunit alpha-4
Protein synonyms
cholinergic receptor, nicotinic alpha 4, cholinergic receptor, nicotinic, alpha 4 (neuronal), cholinergic receptor, nicotinic, alpha polypeptide 4, neuronal nicotinic acetylcholine receptor alpha-4 subunit
Uniprot ID
Mouse ortholog
Chrna4 (11438)
neuronal acetylcholine receptor subunit alpha-4 (Q9ET51)
Alternate
CHRNA3
CHRNA3
Organism
Homo sapiens
Gene name
CHRNA3
Gene synonyms
NACHRA3
NCBI Gene ID
Protein name
neuronal acetylcholine receptor subunit alpha-3
Protein synonyms
cholinergic receptor, nicotinic alpha 3, cholinergic receptor, nicotinic, alpha 3 (neuronal), cholinergic receptor, nicotinic, alpha polypeptide 3, neuronal nicotinic acetylcholine receptor, alpha3 subunit
Uniprot ID
Mouse ortholog
Chrna3 (110834)
neuronal acetylcholine receptor subunit alpha-3 (Q8R4G9)
Variants
Clinical Variant
No data
Financial
Chantix - Pfizer
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Tyrvaya - Oyster Point Pharma
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,059 documents
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Safety
Black-box Warning
Black-box warning for: Chantix
Adverse Events
Top Adverse Reactions
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59,178 adverse events reported
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