Back to discover
Disease

Smoking cessation

Late-stage therapeutic development
24
Clinical trials
12
Associated genes
3
Related proteins
Latest activity
beta

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

Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients Throughout Florida

Clinical trial2026-09-15Status changed to Completed · ClinicalTrials.gov

Expanding the Role of the Safety Manager to Implement a Workplace Smoking Cessation Program in the Construction Sector

Clinical trial2026-08-21Status changed to Active, not recruiting · ClinicalTrials.gov

Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients Throughout Florida

Clinical trial2026-07-08Status changed to Active, not recruiting · ClinicalTrials.gov

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 5 clinical trials expected to report results, the earliest in Q3 2027.
  • 8 industry developments reported.
Upcoming Milestones
Major developments
Upcoming trial readoutHigh impact
Using Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation
Results expected Q1 20282026-09-25
Major trial resultsHigh impact
BREATHE 2 Cluster-randomized Trial of Health System Changes to Increase Reach of Smoking Cessation Treatments
Results posted2026-06-26
Clinical Milestones11View all 11
Results posted 2
Results expected 5
Recently completed 3
Other updates 1
+3 more in the activity timeline below
Industry & Market8View all 8
+3 more in the activity timeline below
Activity timeline19

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Vareniclineapproved

Original application approval — Champix is indicated for smoking cessation in adults. (2006)

Clinical trials

13 sponsors · 2 new · 2 completed in the last 12 months (net +1)

The current development programme across all trial phases.

Clinical programme
24
All trials
6
Active
17
Late-stage
6
Completed
Late-stage studies

Comparing Three Multicomponent Interventions to Help Adults Quit Smoking

Phase 4 · Recruiting · University of Wisconsin, Madison

Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care

Phase 4 · Recruiting · New York University

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

Phase 2/3 · Recruiting · Johns Hopkins University

Using Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation

Phase 2/3 · Recruiting · Mayo Clinic

Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial

Phase 4 · Recruiting · Centre for Addiction and Mental Health

Cytisine: Testing Its Potential as a Therapeutic Strategy for Smoking Cessation Among People With Concurrent Alcohol Use Disorder

Phase 4 · Completed · Centre for Addiction and Mental Health
Recruiting

Comparing Three Multicomponent Interventions to Help Adults Quit Smoking

Phase 4 · Recruiting · University of Wisconsin, Madison

Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care

Phase 4 · Recruiting · New York University

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

Phase 2/3 · Recruiting · Johns Hopkins University

Using Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation

Phase 2/3 · Recruiting · Mayo Clinic

Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial

Phase 4 · Recruiting · Centre for Addiction and Mental Health
Recently completed

Cytisine: Testing Its Potential as a Therapeutic Strategy for Smoking Cessation Among People With Concurrent Alcohol Use Disorder

Phase 4 · Completed · Centre for Addiction and Mental Health

Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders

Phase 3 · Completed · Rose Research Center, LLC

A Multicenter, Open-Label Study Assessing Long-Term Exposure With Cytisinicline 3 mg TID

Phase 3 · Completed · Achieve Life Sciences

Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

Phase 4 · Completed · University of Alabama at Birmingham

A Randomized Controlled Trial to Determine the Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette

Phase 3 · Completed · Rose Research Center, LLC

BREATHE 2 Cluster-randomized Trial of Health System Changes to Increase Reach of Smoking Cessation Treatments

Phase 4 · Completed · University of Wisconsin, Madison

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

Product approvals and authorisations
2006emaOriginal application approval — Varenicline· Champix is indicated for smoking cessation in adults. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

CHRNA40.54SOX60.49CTTNBP20.45JADE20.44FAM163B0.42BARHL20.41LMO30.41CXXC40.41ROBO20.39ATXN7L3B0.39TMEM170.39DEPDC1B0.38

Disease biology

3 matches

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Neuronal acetylcholine receptor subunit alpha-4via CHRNA40.54Protachykinin-1via TAC10.35Sex hormone-binding globulinvia SHBG0.30
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.