What are the next tobacco use disorder trial readouts?

Upcoming catalysts include Brenipatide (Primary completion Feb 2027 (RENEW-Smk-1)).

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

3 compounds from 3 companies are in active clinical development for tobacco use disorder.

3Compounds

3Companies

0Phase 3+

1Upcoming readout

50Trials recruiting

Phase 22

Discontinued1

EMB-001 (metyrapone/oxazepam)Embera NeuroTherapeutics, Inc.CYP11B1 Inhibitor

Mechanisms: Small molecule (2) · Peptide (1)

Pipeline data compiled October 2026 · every fact sourced.

Upcoming readouts & recent results

Primary completion Feb 2027 (RENEW-Smk-1)AnticipatedBrenipatideTopline dataNCT07223840
2026-08-14ReportedAXS-05 (dextromethorphan-bupropion)Registry resultsmet
Pivotal Phase 3 smoking-cessation trial of AXS-05 (NCT07766655) registered and recruiting ↗
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 (3)

Compound	Company	Phase	Status	Mechanism
AXS-05 (dextromethorphan-bupropion)	Axsome Therapeutics, Inc.	Phase 2	Active	NMDA receptor Antagonist
Brenipatide	Eli Lilly and Company	Phase 2	Active	Glucagon-like peptide 1 receptor Agonist
EMB-001 (metyrapone/oxazepam)	Embera NeuroTherapeutics, Inc.	Discontinued	Discontinued	CYP11B1 Inhibitor

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?: 3 compounds from 3 companies are in active clinical development for tobacco use disorder.
What are the next tobacco use disorder trial readouts?: Upcoming catalysts include Brenipatide (Primary completion Feb 2027 (RENEW-Smk-1)).
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.