Nicotine Replacement

Phase 3Small molecule

GSK

Nicotine Replacement is one of 137 small molecule programs targeting Smoking Cessation. It is currently in Phase 3.

Indications

Total Trials

Active Trials

136

Competitors

Pipeline

Status by Indication[3][1]

Indication

Smoking CessationCompleted

CancerWithdrawn

Lung CarcinomaActive, not recruiting

Lung CancerActive, not recruiting

Smoking BehaviorActive, not recruiting

Executive FunctionActive, not recruiting

SmokingCompleted

Tobacco DependenceActive, not recruiting

Smoking CessationPhase 3

Completed

CancerPreclinical

Withdrawn

Lung CarcinomaPreclinical

Active, not recruiting

Lung CancerPreclinical

Active, not recruiting

Smoking BehaviorPreclinical

Active, not recruiting

Executive FunctionPreclinical

Active, not recruiting

SmokingPreclinical

Completed

Tobacco DependencePhase 3

Active, not recruiting

Competition

Competitive Landscape

206 competitors in Lung Cancer

#DrugCompanyPhaseTrials

Imfinzi

AstraZeneca

Phase 3

25 2

Beyfortus

BeiGene

Phase 3

10 3

Abraxane

Bristol-Myers Squibb

Phase 3

7 4

Tecentriq

Roche

Phase 3

6 5

Alecensa

Roche

Phase 3

3 6

DATROWAY

Daiichi Sankyo

Phase 3

2 7

Ilaris

Novartis

Phase 3

2 8

Verzenio

Eli Lilly

Phase 3

2 9

Zepzelca

Jazz Pharmaceuticals

Phase 3

2 10

Tarlatamab-Dznl

Amgen

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

PreclinicalActive, not recruiting

Lung Carcinoma

NCT05144542

Post-ApprovalRecruiting

Nicotine Dependence

NCT06534047

Q1 2027

Phase 2Recruiting

Opioid Use Disorder

NCT05722561

Q2 2027

ApprovedActive, not recruiting

Tobacco Dependence

NCT07220356

Q3 2027

Phase 3Recruiting

Diabetes Mellitus, Type 2

NCT07059377

Clinical

Trials by Indication[1]

Smoking Cessation9 trials

Smoking Cessation in Alcoholism Treatment

Completed·YYale University·Phase 4·NCT00000454·112 enrolled

Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients

Completed·WWake Forest University Health Sciences·Phase 1·NCT01434342·146 enrolled

Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers

Completed·MM.D. Anderson Cancer Center·N/A·NCT02964182·213 enrolled

Show 6 more trials

Study to Evaluate Music Therapy and Nicotine Replacement Therapy on Craving Related to Smoking Cessation in Health Staff

Unknown status·PPoitiers University Hospital·N/A·NCT06130423·50 enrolled

Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial

Recruiting·MM.D. Anderson Cancer Center·Phase 4·NCT04604509·2,010 enrolled

Episodic Future Thinking and Future Thinking Priming for Smoking Cessation

Terminated·RRoswell Park Cancer Institute·N/A·NCT04297332·26 enrolled

Study to Evaluate Music Therapy and Nicotine Replacement Therapy on Craving Related to Smoking Cessation in Students

Recruiting·PPoitiers University Hospital·N/A·NCT05589220·120 enrolled

Bupropion Hydrochloride or Patient's Choice for Smoking Cessation in Patients With Squamous Cell Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy

Terminated·WWake Forest University Health Sciences·Phase 1·NCT02582008·9 enrolled

Smoking Cessation in a Cohort HIV+ Rio de Janeiro, Brazil.

Completed·IInstituto Fernandes Figueira··NCT05873738·115 enrolled

Tobacco Cessation3 trials

C-Raven, a Virtual Tobacco Cessation Intervention in the Community

Completed·JJohns Hopkins University·Phase 4·NCT06545669·10 enrolled

Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community

Completed·JJohns Hopkins University·Phase 4·NCT06289192·5 enrolled

Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

Completed·HHospital do Coracao·N/A·NCT01734330·200 enrolled

Treatment2 trials

Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)

Completed·MMinneapolis Veterans Affairs Medical Center·Phase 4·NCT00000444·500 enrolled

Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices

Completed·EECOG-ACRIN Cancer Research Group·N/A·NCT03808818·306 enrolled

Nicotine Dependence2 trials

Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT00000447·200 enrolled

Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial

Recruiting·CCentre for Addiction and Mental Health·Phase 4·NCT06534047·40 enrolled

Lung Cancer1 trial

Effectiveness of an Enhanced Tobacco Intervention Protocol Compared to Standard Treatment in Helping Head and Neck and Lung Cancer Patients Starting Treatment to Reduce Cigarette Use

Completed·TThomas Jefferson University·N/A·NCT04694846·19 enrolled

15 more indications

Opioid Use Disorder1 trial

E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder

Recruiting·NNYU Langone Health·Phase 2·NCT05722561·302 enrolled

Prevention1 trial

Relapse Prevention Study in Newly Abstinent Smokers

Withdrawn· GSK logo

GSK·Phase 2·NCT00793468

Schizophrenia1 trial

Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

Completed·—·Phase 2·NCT01213524·75 enrolled

Smokers1 trial

Targeted Interventions for Weight-Concerned Smokers

Completed·YYale University·Phase 2·NCT00105482·172 enrolled

CAR1 trial

Treating Caregivers Who Smoke at AFCH

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT06051474·23 enrolled

Alcohol1 trial

Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

Completed·MMayo Clinic·Phase 4·NCT00004551·144 enrolled

Cardiac Disease1 trial

Reduction of Smoking in Cardiac Disease Patients

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00469885·152 enrolled

Cigarette Smoking1 trial

Bronchoscopy in Determining the Effect of E-Cigarette Smoking on Biomarkers in the Lungs

Unknown status·OOhio State University Comprehensive Cancer Center·Phase 1·NCT03691350·239 enrolled

Smoking1 trial

Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes

Completed·MM.D. Anderson Cancer Center·N/A·NCT03856515·169 enrolled

Recruiting·OOttawa Heart Institute Research Corporation·Phase 3·NCT07059377·100 enrolled

Lung Carcinoma1 trial

The Potential Risks and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT05144542·135 enrolled

Tobacco Dependence1 trial

C-Raven: Pilot RCT of an Avatar-delivered Computerized Intervention for Tobacco Cessation With Community Health Worker Linkage to Lung Cancer Screening in Baltimore City (FY26)

Active, not recruiting·JJohns Hopkins University·Approved·NCT07220356·30 enrolled

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Nicotine Replacement. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nicotine Replacement compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nicotine Replacement. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: GSK

Nicotine Replacement

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Smoking Cessation9 trials

Tobacco Cessation3 trials

Treatment2 trials

Nicotine Dependence2 trials

Lung Cancer1 trial

Opioid Use Disorder1 trial

Prevention1 trial

Schizophrenia1 trial

Smokers1 trial

CAR1 trial

Alcohol1 trial

Cardiac Disease1 trial

Cigarette Smoking1 trial

Smoking1 trial

Smoking Behavior1 trial

Cancer1 trial

Executive Function1 trial

Diabetes Mellitus, Type 21 trial

Lung Carcinoma1 trial

Tobacco Dependence1 trial

References

Drug Info

Quick Facts

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