VARENICLINE TARTRATE
Varenicline tartrate helps patients who are working toward quitting smoking. It is used as a support tool during smoking cessation to help manage the challenges of stopping tobacco use. By interacting with specific receptors in the brain, it assists individuals in transitioning away from nicotine dependence.
How VARENICLINE TARTRATE Works
This medication works by binding to α4β2 nicotinic receptors in the brain, where it acts as a partial agonist to stimulate activity at a much lower level than nicotine. At the same time, it blocks nicotine from attaching to these same receptors, which prevents the stimulation of the dopamine system responsible for the feelings of reinforcement and reward associated with smoking.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-08-11
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
VARENICLINE TARTRATE Approval History
What VARENICLINE TARTRATE Treats
1 indicationsVARENICLINE TARTRATE is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Smoking Cessation
VARENICLINE TARTRATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VARENICLINE TARTRATE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05703672 | STUDY00146887 | Ph 3 | recruiting | Switching to E-cigarettes in Smokers Not Interested in Quitting |
| NCT05541497 results posted | 2000032740 000 | Ph 2 | completed | Varenicline for Treatment of E-cigarette Dependence |
| NCT03235505 EFFECT | WI218780 | Ph 4 | completed | Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers |
| NCT03897439 results posted | Study0000142310 R01DA046576 | Ph 3 | completed | Individualizing Pharmacotherapy for African American Smokers |
| NCT01574703 CATS results posted | A3051148 2011-005513-37, CATS | Ph 4 | completed | Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. |
| NCT01456936 EAGLES results posted | A3051123 2010-022914-15, EAGLES | Ph 4 | completed | Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders |
| NCT00717093 results posted | A3051104 | Ph 4 | completed | Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use |
| NCT01370356 results posted | A3051075 REDUCE TO QUIT | Ph 4 | completed | A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction |
| NCT00661765 | A3051071 | Ph 1 | completed | A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch) as Compared to Oral Varenicline in Adult Smokers. |
| NCT07596485 RELIEF | KT74863-101 | Ph 1, Ph 2 | recruiting | RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VARENICLINE TARTRATE FDA Label Details
Indications & Usage
VARENICLINE TARTRATE is indicated for the treatment of Smoking Cessation.
Looking for the branded version?
CHANTIX
Full clinical data, patents, trials, and competitive landscape for varenicline tartrate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment