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Tobacco Dependence

5
Pipeline Programs
6
Companies
13
Clinical Trials
0
Approved Products

Pipeline by Development Stage

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

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
3 programs
1
1
1.0mg Varenicline b.i.d.Phase 4
support and visitsPhase 2/31 trial
vareniclineN/A1 trial
Active Trials
NCT00747643Completed163Est. Aug 2010
NCT00977249Unknown200Est. Dec 2011
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
1
1.0mg Varenicline b.i.d.Phase 41 trial
Active Trials
NCT03557294Completed313Est. Apr 2022
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
Nicotine SprayPhase 3
Vincere Biosciences
Vincere BiosciencesMA - Cambridge
1 program
1
Quitline Treatment as UsualPhase 1/21 trial
Active Trials
NCT05327660Completed229Est. Nov 2022
Johnson & Johnson
Johnson & JohnsonNEW BRUNSWICK, NJ
8 programs
Code STDN/A1 trial
NicotineN/A1 trial
Nicotine Medicated GumN/A1 trial
Nicotine Sublingual Tablet MintN/A1 trial
Nicorette Strongmint lozenge 4 mgPHASE_11 trial
+3 more programs
Active Trials
NCT01238640Completed84Est. Nov 2008
NCT01152736Completed19Est. Jan 2009
NCT01234896Completed44Est. Dec 2010
+5 more trials
Sound Pharmaceuticals
1 program
Tobacco/Physical Activity InterventionN/A1 trial
Active Trials
NCT02137902Completed299Est. Mar 2020

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Angeles Therapeutics1.0mg Varenicline b.i.d.
Johnson & JohnsonNicotine Gum
Pfizersupport and visits
Vincere BiosciencesQuitline Treatment as Usual
Johnson & JohnsonNicotine Spray
Johnson & JohnsonNicorette Strongmint lozenge 4 mg
Johnson & JohnsonNicotine
Sound PharmaceuticalsTobacco/Physical Activity Intervention
Johnson & JohnsonNicotine Medicated Gum
Johnson & JohnsonNicotine
Pfizervarenicline
Johnson & JohnsonCode STD
Johnson & JohnsonNicotine Sublingual Tablet Mint

Clinical Trials (13)

Total enrollment: 2,009 patients across 13 trials

NCT03557294Angeles Therapeutics1.0mg Varenicline b.i.d.

Varenicline OTC Trial on Efficacy and Safety

Start: May 2018Est. completion: Apr 2022313 patients
Phase 4Completed

Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

Start: Feb 2009Est. completion: Nov 2009300 patients
Phase 4Completed
NCT00977249Pfizersupport and visits

Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users

Start: Sep 2009Est. completion: Dec 2011200 patients
Phase 2/3Unknown
NCT05327660Vincere BiosciencesQuitline Treatment as Usual

CO Monitoring for Tobacco Cessation in Quitlines

Start: Dec 2021Est. completion: Nov 2022229 patients
Phase 1/2Completed

A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers

Start: Dec 2017Est. completion: Apr 201824 patients
Phase 1Completed
NCT03130179Johnson & JohnsonNicorette Strongmint lozenge 4 mg

A Bioequivalence Study Between Two Nicotine Replacement Therapies in Adult Healthy Smokers Motivated to Quit.

Start: Mar 2017Est. completion: Jun 2017244 patients
Phase 1Completed

Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

Start: Feb 2011Est. completion: Jun 201150 patients
Phase 1Completed
NCT02137902Sound PharmaceuticalsTobacco/Physical Activity Intervention

Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study

Start: Jun 2015Est. completion: Mar 2020299 patients
N/ACompleted
NCT01234896Johnson & JohnsonNicotine Medicated Gum

Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

Start: Oct 2010Est. completion: Dec 201044 patients
N/ACompleted

Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum

Start: Nov 2008Est. completion: Jan 200919 patients
N/ACompleted

Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

Start: Sep 2008Est. completion: Aug 2010163 patients
N/ACompleted

Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab

Start: Aug 2008Est. completion: Nov 200884 patients
N/ACompleted
NCT01238627Johnson & JohnsonNicotine Sublingual Tablet Mint

Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg

Start: Sep 2007Est. completion: Nov 200740 patients
N/ACompleted

Phase Legend

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

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
6 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.