CHANTIX (varenicline tartrate)
Chantix helps patients who are trying to quit smoking. This medication serves as an aid during smoking cessation treatment by interacting with specific nicotine receptors in the brain. It is used to help manage the process of stopping tobacco use by interfering with the neurological rewards usually triggered by nicotine.
How CHANTIX Works
This drug works by binding selectively to α4β2 neuronal nicotinic acetylcholine receptors, where it triggers a lower level of activity than nicotine itself. By occupying these sites, it simultaneously blocks nicotine from attaching to the receptors, which prevents the activation of the dopamine system responsible for the feelings of reinforcement and reward.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2006-05-10
- Routes
- ORAL
- Dosage Forms
- TABLET
CHANTIX Approval History
What CHANTIX Treats
1 indicationsCHANTIX is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Smoking Cessation
CHANTIX Boxed Warning
SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking CHANTIX. Some reported cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attemp...
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking CHANTIX. Some reported cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking CHANTIX who continued to smoke. All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking CHANTIX in the postmarketing experience. When symptoms were reported, most were during CHANTIX treatment, but some were following discontinuation of CHANTIX therapy. These events have occurred in patients with and without pre-existing psychiatric disease. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the premarketing studies of CHANTIX. Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of CHANTIX was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided un
CHANTIX 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 CHANTIX
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 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 |
| NCT02859142 results posted | 15-1615 | Ph 4 | completed | Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation |
| NCT02360631 KIS-IV results posted | STUDY00000721 R01DA035796 | Ph 4 | completed | Advancing Tobacco Use Treatment for African American Smokers |
| NCT03069768 mSMART-v | Pro00080336 271201400069C-0-0-1 | Ph 1 | withdrawn | Stage Ib Trial of mSMART With Varenicline |
| 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 |
| NCT01806779 ConNic5 results posted | Pro00042699 1P50DA027840-01A1 | Ph 2 | completed | Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers |
| 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.
CHANTIX FDA Label Details
Indications & Usage
FDA Label (PDF)CHANTIX is indicated for the treatment of Smoking Cessation.
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking CHANTIX. Some reported cases may have been complicated by the symptoms of nicotine withd...
Track CHANTIX with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
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