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
Chantix, Tyrvaya, Varenicline (discontinued: Varenicline)
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 |
| CHANTIX | CV Sciences | N-021928 RX | 2006-05-10 | 2 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| chantix | New Drug Application | 2026-01-23 |
| tyrvaya | New Drug Application | 2024-02-12 |
| varenicline | ANDA | 2026-03-23 |
| varenicline tartrate | ANDA | 2026-01-07 |
| varenicline tartrate varenicline tartrate | ANDA | 2025-10-31 |
| varenicline varenicline | ANDA | 2024-09-27 |
| varenicline varenicline tartrate | ANDA | 2025-12-03 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
VARENICLINE TARTRATE, TYRVAYA, OYSTER POINT PHARMA | |||
| 2024-10-15 | NP | ||
HCPCS
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Clinical
Clinical Trials
397 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dry eye syndromes | D015352 | — | H04.12 | 1 | 4 | 3 | 2 | — | 9 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | 1 | 3 | 3 | 2 | — | 8 |
| Eye diseases | D005128 | EFO_0003966 | H44 | 1 | 4 | 3 | 1 | — | 8 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | — | — | 1 | — | 1 |
| Syndrome | D013577 | — | — | — | — | — | 1 | — | 1 |
| Keratoconjunctivitis | D007637 | — | H16.2 | — | — | — | 1 | — | 1 |
Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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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 | — |
| 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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Tyrvaya – Oyster Point Pharma
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Chantix – Pfizer
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Estimated US medical usage
Varenicline
Total medical expenditures per year (USD, in millions)
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Trends
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Additional graphs summarizing 9,436 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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91,029 adverse events reported
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