What are the next tobacco use disorder trial readouts?

Upcoming catalysts include AXS-05 (dextromethorphan-bupropion) (Pivotal Phase 2/3 initiation Q2 2026).

How many clinical trials are recruiting for tobacco use disorder?

50 drug-interventional tobacco use disorder trials are currently recruiting participants, out of 492 registered interventional trials.

Substance Use Disorders

Tobacco use disorder drug pipeline

ICD-11 6C4A
MeSH D014029

1 compound from 1 company is in active clinical development for tobacco use disorder.

1Compound

1Company

0Phase 3+

1Upcoming readout

50Trials recruiting

Phase 2 1

Mechanisms: Small molecule (1)

Pipeline data compiled July 2026 · every fact sourced.

Upcoming readouts & recent results

Pivotal Phase 2/3 initiation Q2 2026AnticipatedAXS-05 (dextromethorphan-bupropion)Registry results
Axsome plans to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in Q2 2026 ↗
2019-04-15ReportedAXS-05 (dextromethorphan-bupropion)Topline datametNCT03471767
AXS-05 meets primary endpoint in Phase 2 smoking-cessation trial: 25% greater reduction in cigarettes/day vs bupropion (P=.0016) ↗

See the full catalyst calendar →

Compounds in development (1)

Compound	Company	Phase	Status	Mechanism
AXS-05 (dextromethorphan-bupropion)	Axsome Therapeutics, Inc.	Phase 2	Active	NMDA receptor Antagonist

Trials recruiting now (50)

50 drug-interventional tobacco use disorder trials recruiting now, of 492 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4Varenicline for Smoking Reduction in Veterans Not Ready To Quit
Motivation-Phase Varenicline, Motivation-Phase Nicotine Mini-Lozenge, Cessation-Phase Combination Nicotine Replacement Therapy (NRT), Cessation-Phase Varenicline
VA Office of Research and Developmentn=400United States · 4 sitesStarted Jul 2026NCT06966362
Phase 4Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)
varenicline
Massachusetts General Hospitaln=30United States · 1 siteStarted Mar 2026NCT07145866
Phase 4Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking
Daridorexant 50 mg
Legacy Health Systemn=44United States · 1 siteStarted Feb 2026NCT07328594
Phase 4C-Raven, a Virtual Tobacco Cessation Intervention in Residency Clinics
Nicotine Replacement Product
Johns Hopkins Universityn=30United States · 1 siteStarted Dec 2025NCT07220356
Phase 4Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness
Nicotine Replacement Therapy (NRT)
University of California, San Franciscon=150United States · 1 siteStarted Nov 2025NCT07148232
Phase 4tDCS Plus Varenicline for Smoking Cessation
Varenicline 1mg BID
Centre for Addiction and Mental Healthn=160Canada · 1 siteStarted Mar 2025NCT06798324
Phase 4E-cigarette Cessation in Adults Who Co-use Cannabis
Varenicline Pill
Medical University of South Carolinan=105United States · 3 sitesStarted Feb 2025NCT06688539
Phase 4Beta-Adrenergic Modulation of Drug Cue Reactivity
Propranolol, Nicotine Patch, Placebo Propranolol, Placebo Patch
University of Oklahoman=80United States · 1 siteStarted Nov 2024NCT05587361
Phase 4Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial
Nicotine replacement
Centre for Addiction and Mental Healthn=40Canada · 1 siteStarted Sep 2024NCT06534047
Phase 4Smoking Cessation and Menstrual Cycle Phase
Nicotine Replacement Therapy Agent
Centre for Addiction and Mental Healthn=1,200Canada · 1 siteStarted Nov 2022NCT05515354
Phase 4Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Cephalexin, Doxycycline, Cefadroxil
Mayo Clinicn=4,618United States · 2 sitesStarted Jun 2020NCT04297592
Phase 4Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
Varenicline
Corporal Michael J. Crescenz VA Medical Centern=10United States · 1 siteStarted Jan 2019NCT03495024

Showing the 12 most advanced of 50 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for tobacco use disorder?: 1 compound from 1 company is in active clinical development for tobacco use disorder.
What are the next tobacco use disorder trial readouts?: Upcoming catalysts include AXS-05 (dextromethorphan-bupropion) (Pivotal Phase 2/3 initiation Q2 2026).
How many clinical trials are recruiting for tobacco use disorder?: 50 drug-interventional tobacco use disorder trials are currently recruiting participants, out of 492 registered interventional trials.