Nicotine Dependence

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

PfizerNEW YORK, NY

6 programs

VareniclinePhase 45 trials

VarineclinePhase 41 trial

VareniclinePhase 31 trial

varenclinePhase 1/21 trial

VareniclineN/A1 trial

+1 more programs

Active Trials

NCT01632189Completed8Est. Aug 2015

NCT00602927Completed38Est. Aug 2008

NCT00571805Withdrawn0

+7 more trials

Human BioSciencesWV - Martinsburg

2 programs

Nicotrol InhalerPhase 41 trial

Very low nicotine content cigarettesN/A1 trial

Active Trials

NCT02599571Terminated71Est. Sep 2019

NCT01656733Completed154Est. Oct 2017

Angeles TherapeuticsCA - Los Angeles

4 programs

VareniclinePhase 21 trial

e-cig with nicotineN/A1 trial

one time exposure to e-cig with nicotineN/A1 trial

Active Trials

NCT03072628Completed148Est. Dec 2022

NCT02724241Completed100Est. Dec 2021

NCT02740595Completed148Est. Dec 2022

+1 more trials

ViiV HealthcareNC - Durham

2 programs

GSK598809Phase 2

GW468816Phase 2

SandozAustria - Kundl

1 program

NIC002 in Aluminum hydroxidePhase 2

Intelligent TherapeuticsCA - La Jolla

2 programs

mSMARTPhase 11 trial

mSMARTN/A1 trial

Active Trials

NCT02635919Unknown60Est. Nov 2018

NCT03069768Withdrawn0Est. Jun 2019

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

PfizerVarenicline

PfizerVarinecline

PfizerVarenicline

Human BioSciencesNicotrol Inhaler

PfizerVarenicline

Angeles TherapeuticsVarenicline

Pfizervarencline

Intelligent TherapeuticsmSMART

PfizerVarenicline

Angeles Therapeuticse-cig with nicotine

Intelligent TherapeuticsmSMART

Showing 15 of 21 trials with date data

Clinical Trials (21)

Total enrollment: 6,310 patients across 21 trials

NCT03365362 PfizerVarenicline

A Trial of Directly Observed and Long-term Varenicline

Start: Oct 2018Est. completion: Apr 2024243 patients

Phase 4Completed

NCT02575183 PfizerVarinecline

Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

Start: Aug 2016Est. completion: Mar 2021152 patients

Phase 4Completed

NCT01836276 PfizerVarenicline

Understanding Disparities in Quitting in African American and White Smokers

Start: Feb 2013Est. completion: Apr 2017449 patients

Phase 4Completed

NCT01656733 Human BioSciencesNicotrol Inhaler

Nicotine Replacement for Smoking Cessation During Pregnancy

Start: Aug 2012Est. completion: Oct 2017154 patients

Phase 4Completed

NCT00948155 PfizerVarenicline

Measuring Smoking Behaviors While Using Varenicline

Start: Jan 2009Est. completion: Nov 201048 patients

Phase 4Completed

NCT01162239 PfizerVarenicline

Maintaining Nonsmoking

Start: May 2010Est. completion: Jun 2016216 patients

Phase 3Completed

NCT00749658 PfizerVarenicline

Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

Start: Nov 2008Est. completion: Sep 2010121 patients

Phase 2/3Completed

NCT02501265 PfizerVarenicline

Adaptive Pharmacotherapy for Smoking Cessation

Start: Jun 2017Est. completion: May 2021188 patients

Phase 2Completed

NCT02698215 Angeles TherapeuticsVarenicline

Combining Varenicline and Naltrexone for Smoking Cessation

Start: May 2016Est. completion: Dec 2019165 patients

Phase 2Completed

NCT00571805 Pfizervarencline

Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt

Start: Sep 20070

Phase 1/2Withdrawn

NCT03069768 Intelligent TherapeuticsmSMART

Stage Ib Trial of mSMART With Varenicline

Start: Apr 2018Est. completion: Jun 20190

Phase 1Withdrawn

NCT00527150 PfizerVarenicline

Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers

Start: Oct 2007Est. completion: Feb 200848 patients

Phase 1Completed

NCT00452894 PfizerVarenicline

Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

Start: Mar 2007Est. completion: Mar 200714 patients

Phase 1Completed

NCT03072628 Angeles Therapeuticse-cig with nicotine

E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

Start: Jan 2017Est. completion: Dec 2022148 patients

N/ACompleted

NCT02635919 Intelligent TherapeuticsmSMART

Stage Ib Trial of mSMART for Smoking Cessation Medication Adherence

Start: Apr 2016Est. completion: Nov 201860 patients

N/AUnknown

NCT02599571 Human BioSciencesVery low nicotine content cigarettes

Effects of Nicotine Reduction on Smoking Behavior in ADHD Smokers

Start: Mar 2016Est. completion: Sep 201971 patients

N/ATerminated

NCT02740595 Angeles Therapeuticsone time exposure to e-cig with nicotine

E-cigarettes and Blood Vessel Function

Start: Aug 2015Est. completion: Dec 2022148 patients

N/ACompleted

NCT02724241 Angeles Therapeuticsone time exposure to e-cig with nicotine

E-Cigarettes and SNA

Start: Apr 2015Est. completion: Dec 2021100 patients

N/ACompleted

NCT01632189 PfizerVarenicline

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

Start: Sep 2012Est. completion: Aug 20158 patients

N/ACompleted

NCT00772941 PfizerVarenicline

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

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

N/ACompleted

NCT00602927 PfizerVarenicline

Effects of Varenicline on Brain Activity During Nicotine Abstinence

Start: Nov 2007Est. completion: Aug 200838 patients

N/ACompleted

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

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

9 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.