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AboutPricing
Drug ReportsVarenicline
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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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
behavior and behavior mechanismsD001520
Trade Name
FDA
EMA
Tyrvaya, Varenicline (discontinued: Chantix, 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
TYRVAYAOyster Point PharmaN-213978 RX2021-10-15
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
chantixNew Drug Application2025-01-08
tyrvayaNew Drug Application2024-02-12
vareniclineANDA2025-04-10
varenicline tartrateANDA2025-04-25
varenicline tartrate varenicline tartrateANDA2023-08-25
varenicline vareniclineANDA2024-09-27
varenicline varenicline tartrateANDA2024-11-05
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
VARENICLINE TARTRATE, TYRVAYA, OYSTER POINT PHARMA
2024-10-15NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Varenicline Tartrate, Tyrvaya, Oyster Point Pharma
95046442035-10-19U-1900
95046452035-10-19DP
95329442035-10-19U-1900
95972842035-10-19U-1900
104563962035-10-19DPU-1900
112245982035-10-19U-1900
ATC Codes
N: Nervous system drugs
N07: Other nervous system drugs in atc
N07B: Drugs used in addictive disorders
N07BA: Drugs used in nicotine dependence
N07BA03: Varenicline
HCPCS
No data
Clinical
Clinical Trials
392 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 cessationD016540EFO_00043199912171056
Tobacco use disorderD014029F172544921
SmokingD012907EFO_000431811439
SchizophreniaD012559EFO_0000692F203115
Tobacco use cessationD020340123
Opioid-related disordersD009293EFO_0005611F111112
Mental disordersD001523EFO_0000677F91.922
Problem behaviorD00006655322
DepressionD003863F33.9112
Bipolar disorderD001714EFO_0000289F30.9112
Show 8 more
Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AlcoholismD000437EFO_0003829F10.111
Spinocerebellar degenerationsD013132G1111
Spinocerebellar ataxiasD02075411
Machado-joseph diseaseD017827EFO_000413511
Alzheimer diseaseD000544EFO_0000249F0311
Cognitive dysfunctionD060825G31.8411
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD01059911
Biological availabilityD00168211
Healthy volunteers/patients11
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cigarette smokingD00007386511
Breast neoplasmsD001943EFO_0003869C5011
Congenital abnormalitiesD000013EFO_0003915Q89.911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVarenicline
INNvarenicline
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 classnicotinic acetylcholine receptor partial agonists/agonists
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Structure (InChI/SMILES or Protein Sequence)
c1cnc2cc3c(cc2n1)C1CNCC3C1
Identifiers
PDB
CAS-ID249296-44-4
RxCUI
ChEMBL IDCHEMBL1396
ChEBI ID
PubChem CID170361
DrugBankDB01273
UNII IDW6HS99O8ZO (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
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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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,373 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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90,542 adverse events reported
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