Smoking Cessation

24
Pipeline Programs
14
Companies
50
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
6
1
8
0
8
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
1100%
+ 29 programs with unclassified modality

On Market (1)

Approved therapies currently available

U
TYRVAYAApproved
varenicline
Unknown Company
nasal2021

Competitive Landscape

13 companies ranked by most advanced pipeline stage

Achieve Life Sciences
10 programs
5
1
1
3
CytisiniclinePhase 31 trial
CytisiniclinePhase 31 trial
CytisiniclinePhase 31 trial
CytisinePhase 21 trial
CytisinePhase 1/21 trial
+5 more programs
Active Trials
NCT03268343CompletedEst. Sep 2017
NCT05566288CompletedEst. Dec 2022
NCT05981768CompletedEst. Sep 2023
+7 more trials
Pfizer
PfizerNEW YORK, NY
6 programs
1
1
1
vareniclinePhase 31 trial
VareniclinePhase 21 trial
varenicline free base patchPhase 11 trial
Smoking cessationN/A5 trials
VareniclineN/A1 trial
+1 more programs
Active Trials
NCT04083144Completed50Est. Dec 2022
NCT03556774Unknown2,200Est. Aug 2021
NCT03262662Completed320Est. Jul 2021
+11 more trials
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
2 programs
1
1
Nicotine gumPhase 31 trial
Nicotine replacement therapyPhase 21 trial
Active Trials
NCT00764439Completed258Est. Dec 2008
NCT00840242Completed314Est. May 2000
Sanofi
SanofiPARIS, France
2 programs
2
RimonabantPhase 31 trial
SSR591813LPhase 31 trial
Active Trials
NCT00358228Completed787Est. Aug 2003
NCT00387946Completed630Est. Sep 2007
BrainsWay
BrainsWayJerusalem, Israel
1 program
1
Sham TreatmentPhase 31 trial
Active Trials
NCT02126124CompletedEst. Nov 2019
Axsome Therapeutics
Axsome TherapeuticsNY - New York
1 program
1
AXS-05Phase 21 trial
Active Trials
NCT03471767Completed58Est. Mar 2019
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
1
LiraglutidePhase 2Peptide1 trial
Active Trials
NCT03712098Completed40Est. May 2022
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
1
Probiotic L008-1Phase 21 trial
Active Trials
NCT02492022CompletedEst. Jan 2016
QT
Q TherapeuticsUT - Salt Lake City
1 program
1
Probiotic L008-1Phase 2
Century Therapeutics
Century TherapeuticsPHILADELPHIA, PA
1 program
1
X-22 Smoking Cessation ProductPhase 21 trial
Active Trials
NCT01400815Completed234Est. Dec 2012
City Therapeutics
City TherapeuticsMA - Cambridge
2 programs
The Decídetext programN/A1 trial
rTMS Active 20HzN/A1 trial
Active Trials
NCT03586596CompletedEst. Sep 2021
NCT02822703CompletedEst. Jun 2016
Novartis
NovartisBASEL, Switzerland
1 program
Nicotine replacement therapyN/A1 trial
Active Trials
NCT02470923Unknown90Est. Jul 2017
Jerusalem Pharmaceuticals
Jerusalem PharmaceuticalsIsrael - Ramallah
1 program
Smoking cessation workshopsN/A1 trial
Active Trials
NCT03446183Completed308Est. Sep 2017

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Pfizervarenicline
PfizerSmoking cessation
PfizerSmoking cessation
Pfizervarenicline
PfizerSmoking cessation
PfizerSmoking cessation
Achieve Life SciencesCytisinicline
Achieve Life SciencesCytisinicline
Achieve Life SciencesCytisinicline
PfizerSmoking cessation
BrainsWaySham Treatment
SanofiSSR591813L
Pfizervarenicline
SanofiRimonabant
Johnson & JohnsonNicotine gum

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 17,072 patients across 50 trials

Understanding Disparities in Quitting in African American and White Smokers

Start: Feb 2013Est. completion: Apr 2017449 patients
Phase 4Completed
NCT00889720PfizerSmoking cessation

A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery

Start: Nov 2009Est. completion: Jul 201016 patients
Phase 4Completed
NCT00818207PfizerSmoking cessation

Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit

Start: Mar 2009Est. completion: Sep 20101,380 patients
Phase 4Completed

Measuring Smoking Behaviors While Using Varenicline

Start: Jan 2009Est. completion: Nov 201048 patients
Phase 4Completed
NCT00828113PfizerSmoking cessation

Long-term Varenicline Treatment for Smoking Cessation

Start: Jan 2009Est. completion: Feb 2011101 patients
Phase 4Completed
NCT00596882PfizerSmoking cessation

Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study

Start: Feb 2008Est. completion: Jun 2009100 patients
Phase 4Completed

Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers

Start: May 2024Est. completion: Oct 2025
Phase 3Completed

A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers

Start: Jan 2022Est. completion: Mar 2023
Phase 3Completed

A Study of Cytisinicline for Smoking Cessation in Adult Smokers

Start: Oct 2020Est. completion: Dec 2021
Phase 3Completed
NCT03262662PfizerSmoking cessation

EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking

Start: Oct 2017Est. completion: Jul 2021320 patients
Phase 3Completed
NCT02126124BrainsWaySham Treatment

Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.

Start: Aug 2014Est. completion: Nov 2019
Phase 3Completed

Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN)

Start: Sep 2006Est. completion: Sep 2007630 patients
Phase 3Completed

A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

Start: Apr 2003Est. completion: Mar 20052,000 patients
Phase 3Completed

Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Smoking Cessation (STRATUS US)

Start: Sep 2002Est. completion: Aug 2003787 patients
Phase 3Completed

Smoking Reduction or Cessation With Nicotine Replacement Therapy

Start: Feb 1999Est. completion: May 2000314 patients
Phase 3Completed

Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

Start: Nov 2008Est. completion: Sep 2010121 patients
Phase 2/3Completed

Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)

Start: Jan 2020Est. completion: Feb 2022
Phase 2Terminated

Daily Liraglutide for Nicotine Dependence

Start: Nov 2018Est. completion: May 202240 patients
Phase 2Completed

Trial of Cytisine in Adult Smokers

Start: Nov 2018Est. completion: Apr 2019
Phase 2Completed

AXS-05 Phase II Trial on Smoking Behavior

Start: Mar 2018Est. completion: Mar 201958 patients
Phase 2Completed
NCT02501265PfizerSmoking cessation

Adaptive Pharmacotherapy for Smoking Cessation

Start: Jun 2017Est. completion: May 2021188 patients
Phase 2Completed

Efficacy of 2 Probiotics During Nicotine Replacement Therapy on Withdrawal Symptoms Associated With Smoking Cessation

Start: May 2015Est. completion: Jan 2016
Phase 2Completed
NCT01400815Century TherapeuticsX-22 Smoking Cessation Product

Randomized Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid

Start: Jul 2011Est. completion: Dec 2012234 patients
Phase 2Completed

Effect of Varenicline on Cognitive Function in Cigarette Smokers With Schizophrenia

Start: Mar 2010Est. completion: Aug 201658 patients
Phase 2Completed
NCT00764439Johnson & JohnsonNicotine replacement therapy

Pilot Study of a New Nicotine Replacement Therapy

Start: Oct 2008Est. completion: Dec 2008258 patients
Phase 2Completed

A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers

Start: Oct 2017Est. completion: Oct 2018
Phase 1/2Terminated

Study to Evaluate Effect of Food on Bioavailability of Single 3 mg Tablet and Pharmacokinetics (PK) of Multiple 3 mg Doses in Healthy Adult Smokers

Start: Aug 2023Est. completion: Sep 2023
Phase 1Completed

Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers

Start: Oct 2022Est. completion: Dec 2022
Phase 1Completed

A Single Dose-escalation Study of Cytisine in Adult Smokers

Start: Feb 2019Est. completion: Sep 2019
Phase 1Completed

A Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation

Start: Apr 2018Est. completion: Jun 2018
Phase 1Completed

A Study in Healthy Volunteers to Investigate the Effect of Food on the Bioavailability of Cytisine

Start: Aug 2017Est. completion: Sep 2017
Phase 1Completed
NCT03059940PfizerSmoking cessation

Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer

Start: Jun 2017Est. completion: Jun 2026630 patients
Phase 1Active Not Recruiting

Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

Start: Jul 2014Est. completion: Jun 201986 patients
Phase 1Completed
NCT01234142Pfizervarenicline free base patch

A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days

Start: Nov 2010Est. completion: Mar 201145 patients
Phase 1Completed

A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Patch Applied To The Skin

Start: Dec 2009Est. completion: Dec 200912 patients
Phase 1Completed

A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin

Start: Dec 2008Est. completion: Dec 200812 patients
Phase 1Completed

Smoke-Free Living Study

Start: Jan 2008Est. completion: Nov 2011100 patients
Phase 1Completed

A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers

Start: May 2007Est. completion: Dec 200773 patients
Phase 1Completed
NCT04083144PfizerSmoking cessation

Deep rTMS and Varenicline for Smoking Cessation

Start: Aug 2019Est. completion: Dec 202250 patients
N/ACompleted
NCT03556774PfizerSmoking cessation

Boosting Chinese Healthcare Service Providers' Utilization of Smoking Cessation Interventions by 'WeChat WeQuit' Program

Start: Apr 2019Est. completion: Aug 20212,200 patients
N/AUnknown
NCT03586596City TherapeuticsThe Decídetext program

Mobile Cessation Support for Latino Smokers

Start: Sep 2018Est. completion: Sep 2021
N/ACompleted
NCT03446183Jerusalem PharmaceuticalsSmoking cessation workshops

Short Term Effect of Smoking Cessation on Human Metabolism

Start: Apr 2016Est. completion: Sep 2017308 patients
N/ACompleted
NCT02470923NovartisNicotine replacement therapy

In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy

Start: Aug 2015Est. completion: Jul 201790 patients
N/AUnknown

Enhancing Relapse Prevention for Smoking Cessation With Repetitive Transcranial Magnetic Stimulation

Start: Jan 2015Est. completion: Jun 2016
N/ACompleted

The Effect of Varenicline on D2/D3 Receptor Binding in Smokers

Start: Sep 2012Est. completion: Aug 20158 patients
N/ACompleted
NCT01566097PfizerSmoking cessation

Intervention Trial of Culturally-Appropriate Decision Aids for Smoking Cessation

Start: Apr 2012Est. completion: Jul 2015400 patients
N/AUnknown
NCT01544621PfizerSmoking cessation

Escape Smoke Project: Non-Intervention Non-Drug Multicenter Study on the Real-life Effectiveness of Smoking Cessation in General Practice in Denmark

Start: Nov 2011Est. completion: May 2013544 patients
N/ACompleted
NCT01320462PfizerSmoking cessation

Smoking Cessation Program in the Preadmission Clinic

Start: Dec 2010Est. completion: Apr 2017296 patients
N/ACompleted

"VIBRATIONS" - A Study In Smokers Who Are Willing And Motivated To Stop Smoking With The Aid Of Varenicline Which Will Be Prescribed According To Usual Clinical Practice In Germany

Start: May 2010Est. completion: Mar 20111,177 patients
N/ACompleted

Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)

Start: Feb 2009Est. completion: Dec 20123,939 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

8 late-stage (Phase 3) programs — potential near-term approvals
14 companies competing in this space