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Smoking Cessation

51
Pipeline Programs
30
Companies
50
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
11
0
16
2
11
11
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
133%
Small Molecule
133%
Vaccine
133%
+ 88 programs with unclassified modality

On Market (1)

Approved therapies currently available

Pfizer
CHANTIXApproved
varenicline tartrate
Pfizer
oral2006
88K Part D

Competitive Landscape

31 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
36 programs
5
6
1
7
10
ChantixPhase 41 trial
Full Smoking Cessation Treatment CoveragePhase 41 trial
Message PrimePhase 41 trial
VareniclinePhase 41 trial
VareniclinePhase 41 trial
+31 more programs
Active Trials
NCT01544621Completed544Est. May 2013
NCT00794365Completed330Est. Nov 2009
NCT00669240Completed567Est. Aug 2009
+33 more trials
ViiV Healthcare
ViiV HealthcareNC - Durham
7 programs
2
2
3
High intensity disease managementPhase 3
NicVAX vaccinePhase 3Vaccine
NicotinePhase 3
nicotinePhase 2
nicotinePhase 2
+2 more programs
Achieve Life Sciences
2 programs
1
1
cytisiniclinePhase 35 trials
cytisinePhase 25 trials
Active Trials
NCT03848208Completed74Est. Sep 2019
NCT03709823Completed254Est. Apr 2019
NCT03509948Completed13Est. Jun 2018
+7 more trials
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
3 programs
1
VareniclinePhase 2/31 trial
Forward to QuitN/A1 trial
Nicotine PatchN/A1 trial
Active Trials
NCT07181551Active Not Recruiting44Est. Dec 2031
NCT01889771Completed1,495Est. Mar 2012
NCT05413122Recruiting660Est. Aug 2027
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
2 programs
2
Bupropion HydrochloridePhase 21 trial
CytisiniclinePhase 21 trial
Active Trials
NCT03326128Terminated12Est. Jul 2023
NCT06617312Recruiting64Est. Dec 2026
NFL Biosciences
NFL BiosciencesFrance - Montpellier
2 programs
2
NFL-101Phase 21 trial
NFL-101 dose 1Phase 21 trial
Active Trials
NCT06091826Completed34Est. Sep 2023
NCT04571216Completed318Est. Apr 2024
Axsome Therapeutics
Axsome TherapeuticsNY - New York
1 program
1
AXS-05Phase 21 trial
Active Trials
NCT03471767Completed58Est. Mar 2019
Otsuka
OtsukaJapan - Tokushima
1 program
1
CentanafadinePhase 21 trial
Active Trials
NCT05066724Completed50Est. May 2022
Invion
1 program
1
NadololPhase 2Small Molecule1 trial
Active Trials
NCT01825122Completed155Est. Aug 2015
Human BioSciences
1
Smoking cessationPhase 11 trial
Nicotine Replacement TherapyN/A1 trial
SBIRTN/A1 trial
Active Trials
NCT01008748Completed200Est. Sep 2016
NCT02531594Completed770Est. Dec 2022
NCT00340483Completed291Est. Dec 2006
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
AZD4041Phase 11 trial
Active Trials
NCT04076540Completed48Est. Jan 2022
Biocorp
BiocorpFrance - Issoire
1 program
1
CDFF0318, ChampixPhase 11 trial
Active Trials
NCT04631874Completed32Est. May 2020
Camino Pharma
Camino PharmaCA - San Diego
1 program
1
SBP-9330Phase 11 trial
Active Trials
NCT04948827Completed90Est. Mar 2023
GSK
GSKLONDON, United Kingdom
6 programs
NicotinePHASE_11 trial
NicotinePHASE_11 trial
nicotinePHASE_21 trial
nicotinePHASE_21 trial
High intensity disease managementPHASE_31 trial
+1 more programs
Active Trials
NCT01536704Completed50Est. Aug 2011
NCT01847443Completed84Est. Jun 2013
NCT01669122Completed40Est. Aug 2012
+3 more trials
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
3 programs
CoQuit AppN/A1 trial
High-level construalN/A1 trial
Smokefree Partners: 21 Days to FreedomN/A1 trial
Active Trials
NCT04893460Completed72Est. Sep 2021
NCT04620915Active Not Recruiting300Est. Dec 2025
NCT02329249Completed500Est. Jan 2006
Eppendorf
EppendorfGermany - Hamburg
2 programs
Cognitive-Behavioral TherapyN/A1 trial
InhibitionN/A1 trial
Active Trials
NCT01129999Completed360Est. Apr 2013
NCT04190810Unknown75Est. Sep 2020
Integrated Biosciences
Integrated BiosciencesCA - San Carlos
2 programs
MBRP groupN/A1 trial
Standard smoking cessation treatmentN/A
Active Trials
NCT03930329Completed25Est. Jul 2021
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
Johnson & Johnson
Johnson & JohnsonNEW BRUNSWICK, NJ
2 programs
Nicotine replacement therapyPHASE_25 trials
Nicotine gumPHASE_31 trial
Active Trials
NCT01368016Completed346Est. Jul 2011
NCT01323491Completed184Est. Oct 2012
NCT01227720Completed104Est. Jan 2010
+3 more trials
Sanofi
SanofiPARIS, France
2 programs
RimonabantPHASE_31 trial
SSR591813LPHASE_31 trial
Active Trials
NCT00358228Completed787Est. Aug 2003
NCT00387946Completed630Est. Sep 2007
Sandoz
SandozAustria - Kundl
1 program
Nicotine replacement therapyN/A1 trial
Active Trials
NCT02470923Unknown90Est. Jul 2017
Novartis
NovartisBASEL, Switzerland
1 program
Nicotine replacement therapyN/A
Labcorp
LabcorpBURLINGTON, NC
1 program
Respiragene test and risk scoreN/A1 trial
Active Trials
NCT01176383Completed67Est. Mar 2013
Jerusalem Pharmaceuticals
Jerusalem PharmaceuticalsIsrael - Ramallah
1 program
Smoking cessation workshopsN/A1 trial
Active Trials
NCT03446183Completed308Est. Sep 2017
Cessation Therapeutics
1 program
Standard smoking cessation treatmentN/A1 trial
Active Trials
NCT05370352Completed590Est. Aug 2025
Purdue Pharma
Purdue PharmaCT - Stamford
1 program
intensive cessation messageN/A1 trial
Active Trials
NCT02693626Completed1,369Est. Nov 2017
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
LiraglutidePHASE_2Peptide1 trial
Active Trials
NCT03712098Completed40Est. May 2022
Q Therapeutics
Probiotic L008-1PHASE_2
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
Probiotic L008-1PHASE_21 trial
Active Trials
NCT02492022CompletedEst. Jan 2016
Century Therapeutics
Century TherapeuticsPHILADELPHIA, PA
1 program
X-22 Smoking Cessation ProductPHASE_21 trial
Active Trials
NCT01400815Completed234Est. Dec 2012

+1 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
PfizerChantix
PfizerVarenicline 1mg BID
PfizerVarenicline
Pfizervarenicline
PfizerVarenicline
PfizerVarenicline
PfizerFull Smoking Cessation Treatment Coverage
Pfizervarenicline
Pfizervarenicline tartrate
PfizerMessage Prime
Achieve Life Sciencescytisinicline
Achieve Life Sciencescytisinicline
Achieve Life Sciencescytisinicline
Achieve Life Sciencescytisinicline
BrainsWaySham Treatment

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 19,107 patients across 50 trials

Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation

Start: Mar 2018Est. completion: Oct 2020122 patients
Phase 4Completed
NCT01312909PfizerVarenicline 1mg BID

Smoking Cessation Study In Healthy Adolescent Smokers

Start: Apr 2011Est. completion: Jan 2018312 patients
Phase 4Completed

A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

Start: Dec 2010Est. completion: Nov 2012498 patients
Phase 4Completed

Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression

Start: Mar 2010Est. completion: Jun 2012525 patients
Phase 4Completed

Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder

Start: Jan 2010Est. completion: Mar 201360 patients
Phase 4Completed

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

Start: Nov 2009Est. completion: Jul 201016 patients
Phase 4Completed
NCT00818207PfizerFull Smoking Cessation Treatment Coverage

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

Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo

Start: Sep 2008Est. completion: Aug 2009110 patients
Phase 4Completed
NCT00594204Pfizervarenicline tartrate

Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

Start: Apr 2008Est. completion: Aug 2009593 patients
Phase 4Completed
NCT00596882PfizerMessage Prime

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

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

Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes

Start: May 2026Est. completion: Sep 2027800 patients
Phase 3Not Yet Recruiting

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

Start: May 2024Est. completion: Oct 2025479 patients
Phase 3Completed

A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers

Start: Jan 2022Est. completion: Mar 2023792 patients
Phase 3Completed

A Study of Cytisinicline for Smoking Cessation in Adult Smokers

Start: Oct 2020Est. completion: Dec 2021810 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 2019224 patients
Phase 3Completed

Nicotine Mouth Film for Craving Relief.

Start: Sep 2012Est. completion: Dec 2012320 patients
Phase 3Completed

Combining Varenicline and Bupropion for Smoking Cessation

Start: May 2010Est. completion: Sep 2021641 patients
Phase 3Completed
NCT00440115GSKHigh intensity disease management

Disease Management for Smoking Cessation

Start: Jun 2009Est. completion: Dec 2010750 patients
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
NCT00371813PfizerVarenicline tartrate

An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking

Start: Sep 2006Est. completion: Jun 2007334 patients
Phase 3Completed

A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation

Start: Feb 2005Est. completion: Jan 2006250 patients
Phase 3Completed

An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation

Start: Jan 2005Est. completion: Jun 2006730 patients
Phase 3Completed

A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline

Start: Oct 2003Est. completion: Mar 2005375 patients
Phase 3Completed

A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation

Start: Jun 2003Est. completion: Mar 20051,005 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

Evaluating Smoking Cessation Interventions for PWH in South Africa

Start: Nov 2023Est. completion: Aug 2027660 patients
Phase 2/3Recruiting

Smoking Cessation & Opioid Dependence Treatment Integration

Start: Jul 2016Est. completion: Apr 201774 patients
Phase 2/3Completed

Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity

Start: Dec 2024Est. completion: Dec 202664 patients
Phase 2Recruiting

Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO)

Start: Feb 2023Est. completion: Sep 202334 patients
Phase 2Completed

A Study of Cytisinicline for Vaping Cessation in Adult Smokers

Start: Jul 2022Est. completion: Feb 2023160 patients
Phase 2Completed
NCT05066724OtsukaCentanafadine

Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment

Start: Sep 2021Est. completion: May 202250 patients
Phase 2Completed
NCT03326128Angeles TherapeuticsBupropion Hydrochloride

High Dose Bupropion for Smoking Cessation - Pilot Study

Start: Sep 2021Est. completion: Jul 202312 patients
Phase 2Terminated

Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy

Start: Apr 2021Est. completion: Apr 2024318 patients
Phase 2Completed

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

Start: Jan 2020Est. completion: Feb 202234 patients
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 2019254 patients
Phase 2Completed

AXS-05 Phase II Trial on Smoking Behavior

Start: Mar 2018Est. completion: Mar 201958 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

Efficacy and Safety of Βeta-adrenoceptor Inverse Agonist and Biased Ligand, Nadolol, In Smoking Cessation of Patients With Chronic Cough With or Without Airflow Obstruction

Start: Mar 2014Est. completion: Aug 2015155 patients
Phase 2Completed

Pharmacokinetic Study of 4 mg Nicotine Lozenge.

Start: Jun 2012Est. completion: Aug 201240 patients
Phase 2Completed

Provoked Craving Relief Study by NRT

Start: Nov 2011Est. completion: Jan 2012120 patients
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
NCT00741884PfizerVarenicline Controlled Release 1.2 mg

A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

Start: Aug 2010Est. completion: Aug 20110
Phase 2Withdrawn

An Alternative Dosing Schedule of Varenicline for Smoking Cessation

Start: Mar 2009Est. completion: Jul 201560 patients
Phase 2Completed
NCT00764439Johnson & JohnsonNicotine replacement therapy

Pilot Study of a New Nicotine Replacement Therapy

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

12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation

Start: Dec 2004Est. completion: Feb 2006600 patients
Phase 2Completed

12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation

Start: Dec 2001Est. completion: Sep 2002300 patients
Phase 2Completed

12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.

Start: Sep 2001Est. completion: Oct 2002625 patients
Phase 2Completed

Phase Legend

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

Key Insights

11 late-stage (Phase 3) programs, potential near-term approvals
2 actively recruiting trials targeting 19,107 patients
30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.