Chantix, Champix(varenicline)
Champix, Tyrvaya, Varenicline (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 |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| apo-varenicline | unapproved drug for use in drug shortage | 2023-01-26 |
| chantix | New Drug Application | 2024-04-23 |
| tyrvaya | New Drug Application | 2024-02-08 |
| varenicline | ANDA | 2024-07-16 |
| varenicline tartrate | ANDA | 2024-06-13 |
| varenicline tartrate varenicline tartrate | ANDA | 2023-08-25 |
| varenicline varenicline | ANDA | 2023-11-08 |
| varenicline varenicline tartrate | ANDA | 2024-03-27 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| tobacco use cessation | — | D020340 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
VARENICLINE TARTRATE, TYRVAYA, OYSTER POINT PHARMA | |||
| 2024-10-15 | NP | ||
HCPCS
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Clinical
Clinical Trials
383 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 | — | 15 | 20 | 31 | 45 | 42 | 146 |
| Tobacco use disorder | D014029 | — | F17 | 9 | 28 | 24 | 21 | 30 | 101 |
| Smoking | D012907 | EFO_0004318 | — | 4 | 12 | 8 | 12 | 22 | 52 |
| Cigarette smoking | D000073865 | — | — | 7 | 6 | 2 | 6 | 8 | 27 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 2 | 14 | 3 | 2 | 2 | 20 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 7 | 2 | 9 | 1 | 19 |
| Dry eye syndromes | D015352 | — | H04.12 | 1 | 5 | 5 | 5 | — | 15 |
| Tobacco use cessation | D020340 | — | — | — | 5 | 4 | 5 | 3 | 14 |
| Alcohol drinking | D000428 | EFO_0004329 | — | 3 | 10 | 1 | 2 | 1 | 14 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | 1 | 4 | 5 | 5 | — | 14 |
Show 60 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 2 | 1 | 1 | — | 2 | 5 |
| Weight gain | D015430 | HP_0004324 | — | 2 | 3 | 1 | — | — | 3 |
| Smoking reduction | D000074264 | — | — | — | — | 1 | — | 2 | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 2 | 1 | — | — | 2 |
| Ataxia | D001259 | — | R27.0 | — | 2 | 1 | — | — | 2 |
| Cerebellar ataxia | D002524 | HP_0001251 | — | — | 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 |
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 |
| Cognition | D003071 | EFO_0003925 | — | 1 | 1 | — | — | — | 2 |
| Second primary neoplasms | D016609 | — | — | — | 1 | — | — | — | 1 |
| Body weight | D001835 | EFO_0004338 | — | 1 | 1 | — | — | — | 1 |
| Spinocerebellar degenerations | D013132 | — | G11 | — | 1 | — | — | — | 1 |
| Spinocerebellar ataxias | D020754 | HP_0007263 | — | — | 1 | — | — | — | 1 |
| Machado-joseph disease | D017827 | EFO_0004135 | — | — | 1 | — | — | — | 1 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | — | — | 1 |
| Traumatic stress disorders | D040921 | — | — | — | 1 | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
Show 1 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Head and neck neoplasms | D006258 | — | — | 3 | — | — | — | 2 | 5 |
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | 1 | 2 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | 1 | 2 |
| Squamous cell carcinoma | D002294 | — | — | 1 | — | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Chronic pain | D059350 | HP_0012532 | — | 1 | — | — | — | 1 | 2 |
| Nasopharyngeal carcinoma | D000077274 | — | — | 1 | — | — | — | — | 1 |
| Nasopharyngeal neoplasms | D009303 | — | — | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
Show 1 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | — | — | — | 2 | 2 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 2 | 2 |
| Sleep | D012890 | GO_0030431 | — | — | — | — | — | 1 | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | — | — | — | 1 | 1 |
| Thoracic surgical procedures | D019616 | — | — | — | — | — | — | 1 | 1 |
| Health behavior | D015438 | — | — | — | — | — | — | 1 | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 1 | 1 |
| Respiratory tract diseases | D012140 | — | — | — | — | — | — | 1 | 1 |
| Respiration disorders | D012120 | — | J00-J99 | — | — | — | — | 1 | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | — | 1 | 1 |
Show 26 more
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 | — |
| CAS-ID | 249296-44-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1396 |
| ChEBI ID | — |
| PubChem CID | 170361 |
| DrugBank | DB01273 |
| UNII ID | W6HS99O8ZO (ChemIDplus, GSRS) |
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Chantix – Pfizer
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Tyrvaya – Oyster Point Pharma
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Varenicline
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Safety
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97,199 adverse events reported
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