Overview
Varenicline is a prescription medication used to treat smoking addiction. This medication is the first approved nicotinic receptor partial agonist. Specifically, varenicline is a partial agonist of the alpha4/beta2 subtype of the nicotinic acetylcholine receptor. In addition it acts on alpha3/beta4 and weakly on alpha3beta2 and alpha6-containing receptors. A full agonism was displayed on alpha7-receptors. On March 9, 2015, the U.S. Food and Drug Administration warned that Varenicline, in the form of Pfizer Inc's quit-smoking drug, Chantix, has been associated with seizures and that some patients who drink while taking the drug may become aggressive or black out. Pfizer is conducting an additional safety study of the drug, results of which are expected in late 2015. The FDA said it is keeping the black box in place at least until the results of the trial are announced.
Indication
For use as an aid in smoking cessation. Varenicline as a nasal spray is indicated for the symptomatic treatment of dry eye disease.
Associated Conditions
- Dry Eye Syndrome (DES)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/27 | Not Applicable | Not yet recruiting | |||
2025/03/19 | Phase 3 | Recruiting | |||
2025/03/03 | Phase 1 | Recruiting | |||
2025/02/18 | Phase 4 | Recruiting | |||
2025/01/29 | Phase 4 | Recruiting | |||
2025/01/17 | Phase 3 | Not yet recruiting | Shanghai East Hospital | ||
2024/11/14 | Phase 4 | Recruiting | |||
2024/11/07 | Phase 2 | Recruiting | Vikas Kotagal | ||
2024/09/24 | Phase 2 | Recruiting | |||
2024/09/03 | Early Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| American Health Packaging | 60687-648 | ORAL | 1 mg in 1 1 | 4/5/2024 | |
| AVALANCHE PHARMACEUTICAL LLC | 82582-485 | ORAL | 0.5 mg in 1 1 | 3/19/2024 | |
| Golden State Medical Supply, Inc. | 51407-755 | ORAL | 0.5 mg in 1 1 | 2/21/2024 | |
| Ajanta Pharma USA Inc. | 27241-174 | ORAL | 1 mg in 1 1 | 1/30/2024 | |
| Leading Pharma, LLC | 69315-403 | ORAL | 1 mg in 56 1 | 2/10/2024 | |
| A-S Medication Solutions | 50090-4482 | ORAL | 1 mg in 1 1 | 2/1/2019 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-899 | ORAL | 1 mg in 1 1 | 12/18/2017 | |
| Zydus Lifesciences Limited | 70771-1773 | ORAL | 0.5 mg in 1 1 | 9/28/2023 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1614 | ORAL | 1 mg in 1 1 | 2/10/2024 | |
| Mylan Pharmaceuticals Inc. | 0378-5089 | ORAL | 0.5 mg in 1 1 | 4/15/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/25/2006 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Champix Tablet 1mg | SIN13323P | TABLET, FILM COATED | 1 mg/tablet | 8/1/2007 | |
| Champix Tablet Starter Pack | SIN13322P | TABLET, FILM COATED | 0.5 mg | 8/1/2007 | |
| Champix Tablet Starter Pack | SIN13322P | TABLET, FILM COATED | 1 mg | 8/1/2007 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CHAMPIX 0,5mg 1mg comprimidos recubiertos con pelicula | 06360012IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| CHAMPIX 1 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 06360004 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| CHAMPIX 1 mg comprimidos recubiertos con pelicula | 106360015 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| CHAMPIX 0,5 mg y 1 mg comprimidos recubiertos con pelicula | 106360023 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| CHAMPIX 1mg comprimidos recubiertos con pelicula | 06360005IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| CHAMPIX 0,5 mg 1mg comprimidos recubiertos con pelicula | 06360003IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| CHAMPIX 1mg comprimidos recubiertos con pelicula | 06360004IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| CHAMPIX 1mg comprimidos recubiertos con pelicula | 06360011IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| CHAMPIX 1 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 06360011 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| CHAMPIX 0,5, 1 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 06360003 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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