Drug

Varenicline

Approved · EMA

Emerging researchLate-stage developmentRising momentum

Also known as Chantix, Tyrvaya, Vareniclina, Vareniclinum.

RxNorm591622 ChEMBLCHEMBL1076903UNIIW6HS99O8ZO

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India

Clinical trial2026-07-22Primary completion · ClinicalTrials.gov

Combining Varenicline and Guanfacine for Smoking Cessation

Clinical trial2026-06-09Results posted · ClinicalTrials.gov

Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness

Clinical trial2026-06-09Results expected Q3 2027 · ClinicalTrials.gov

Testing Novel Pharmacogenetic and Adherence Optimization Treatments to Improve the Effectiveness of Smoking Cessation Treatments for Smokers With HIV

Clinical trial2026-06-04Results expected Q4 2026 · ClinicalTrials.gov

PISCES I: Precision Implemented Smoking Cessation Evaluation Study

Clinical trial2026-05-04Results expected Q4 2028 · ClinicalTrials.gov

Randomized Factorial Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention to Promote Smoking Cessation

Clinical trial2026-04-28Results expected Q2 2029 · ClinicalTrials.gov

Varenicline and Combined NRT for Initial Smoking Cessation and Rescue Treatment in Smokers: A Randomized Pilot Trial

Clinical trial2026-04-24Results posted · ClinicalTrials.gov

Varenicline treatment for methamphetamine dependence: A randomized, double-blind phase II clinical trial.

Research2018-05-25Drug and alcohol dependence

Varenicline for tobacco-dependence treatment in alcohol-dependent smokers: A randomized controlled trial.

Research2018-01-02Drug and alcohol dependence

Combination Varenicline and Lorcaserin for Tobacco Dependence Treatment and Weight Gain Prevention in Overweight and Obese Smokers: A Pilot Study.

Research2017-08-01Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco

Varenicline versus nicotine patch with brief advice for smokers with substance use disorders with or without depression: effects on smoking, substance use and depressive symptoms.

Research2017-07-04Addiction (Abingdon, England)

Approval: Champix (EMA)

Regulatory2006-09-25EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Varenicline

Aliases & brands

ChantixTyrvayaVareniclinaVareniclinum

RxNorm CUI

591622

ChEMBL ID

CHEMBL1076903

UNII

W6HS99O8ZO

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2006-09-25

Latest approval

2006-09-25

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2006-09-25Approval

Approval: Champix (EMA)

Indication: Champix is indicated for smoking cessation in adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

196 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

196

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

129

Late-stage (III+)

147

Completed

Discontinued

PHASE DISTRIBUTIONn = 196

Early Phase 15Phase 112Phase 1 / 25Phase 245Phase 2 / 313Phase 330Phase 454Phase N / A32

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

PISCES I: Precision Implemented Smoking Cessation Evaluation Study

RecruitingPH IVKey trialM.D. Anderson Cancer Centern=2,0102028

Dual Use Cessation: A MOST Screening Trial to Identify Effective Interventions to Help People Who Smoke and Vape

RecruitingPH IVUniversity of Wisconsin, Madisonn=5002028

Evaluation of Varenicline and Accelerated TMS for Reduction of Nicotine Use

Not yet recruitingPH IVMassachusetts General Hospitaln=302027

Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial

RecruitingPH IVOttawa Heart Institute Research Corporationn=1502027

Botswana Smoking and Abstinence Reinforcement Trial

Enrolling by invitationPH IVUniversity of Maryland, Baltimoren=7502027

Recent completions

Trials that read out recently, adding to the completed evidence base.

Varenicline and Combined NRT for Initial Smoking Cessation and Rescue Treatment in Smokers: A Randomized Pilot Trial

CompletedPH IVM.D. Anderson Cancer Centern=6312026

Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

CompletedPH IIJoseph Valentino, MDn=1262026

Varenicline in the Treatment of Visceral Sensation: A Pilot Study

CompletedPH IMayo Clinicn=82025

A Preliminary Test of Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use on Behavior, Tobacco Toxicant Exposure, and Health Effects

CompletedPH IYale Universityn=192025

Comparative Effectiveness Trial of Tobacco Cessation Treatments Among Cancer Patients Who Smoke

CompletedPH IVUniversity of Wisconsin, Madisonn=522025

Combining Varenicline and Guanfacine for Smoking Cessation

CompletedPH IIYale Universityn=1672025

Research activity

19 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20092018

Most influential

Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks: A Randomized Clinical Trial.

JAMA · 2016 · 138 cites

Varenicline decreases alcohol consumption in heavy-drinking smokers.

Psychopharmacology · 2012 · 137 cites

Effects of the alpha4beta2 partial agonist varenicline on brain activity and working memory in abstinent smokers.

Biological psychiatry · 2010 · 99 cites

Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial.

JAMA · 2014 · 84 cites

Varenicline for smoking cessation in bipolar disorder: a randomized, double-blind, placebo-controlled study.

The Journal of clinical psychiatry · 2014 · 69 cites

Cognitive and antismoking effects of varenicline in patients with schizophrenia or schizoaffective disorder.

Schizophrenia research · 2009 · 66 cites