Nicotine gum

Phase 3Small molecule

Johnson & Johnson

Nicotine gum is one of 30 small molecule programs targeting Smoking Cessation. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Smoking CessationActive, not recruiting

Smoking CessationPhase 3

Active, not recruiting

Competition

Competitive Landscape

154 competitors in Smoking Cessation

#DrugCompanyPhaseTrials

Wellbutrin

GSK

Phase 3

5 2

Chantix

Pfizer

Phase 3

3 3

Ozempic

Novo Nordisk

Phase 3

2 4

Topamax

WWim Janssens

Phase 3

3 5

Rimonabant

Sanofi

Phase 3

5 6

Revia

Teva

Phase 2

2 7

Lopid

Pfizer

Phase 2

1 8

Standard Treatment

Boehringer Ingelheim

Phase 3

1 9

Pharmacotherapy

UUniversity of Pittsburgh

Phase 3

1 10

Intuniv

PPromius Pharma, LLC

Phase 2

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

Timeline

Expected Milestones

Q4 2026

N/AActive, not recruiting

Smoking Cessation

NCT05290025

Q3 2027

Phase 2/3Recruiting

Smoking Cessation

NCT05413122

Q3 2030

Phase 3Not yet recruiting

Smoking Cessation

NCT06811038

Clinical

Trials by Indication[1]

Oral4 trials

Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·N/A·NCT01228617·40 enrolled

Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

Completed·MMcNeil AB·N/A·NCT01152749·76 enrolled

Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

Completed·MMcNeil AB·N/A·NCT01234896·44 enrolled

Show 1 more trial

Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

Completed·MMcNeil AB·N/A·NCT01084707·40 enrolled

Smoking Cessation4 trials

iCanQuit Smoking Cessation Among Hispanic Adults

Not yet recruiting·FFred Hutchinson Cancer Center·Phase 3·NCT06811038·854 enrolled

Easy Access to Smoking Cessation for People Receiving Opioid Agonist Therapy Who Are Smoking Tobacco

Active, not recruiting·HHaukeland University Hospital·N/A·NCT05290025·266 enrolled

Inpatient Smoking Cessation Pilot Program

Withdrawn·JJohns Hopkins University·Phase 1·NCT05060965

Show 1 more trial

Evaluating Smoking Cessation Interventions for PWH in South Africa

Recruiting·JJohns Hopkins University·Phase 2/3·NCT05413122·660 enrolled

Smokers2 trials

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03398876·24 enrolled

Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

Completed·MMcNeil AB·N/A·NCT01234792·24 enrolled

Treatment2 trials

Identifying Treatments to Motivate Smokers to Quit

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT01122238·517 enrolled

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

Completed·MMcNeil AB·Phase 4·NCT00749463·300 enrolled

Effectiveness1 trial

Comparing the Effectiveness of Combined NRT With Single NRT in Primary Care Clinics in Hong Kong

Completed·HHospital Authority, Hong Kong·N/A·NCT03836560·560 enrolled

15 more indications

Tobacco Cessation1 trial

Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT01087905·987 enrolled

Colorectal Surgery1 trial

Nicotine Gum Recovery After Colorectal Surgery

Terminated·TThe Cleveland Clinic·Phase 4·NCT01662115·4 enrolled

MPA1 trial

Comparison of Pharmacokinetic Profiles of 3 New Nicotine Gum Formulations With a Reference Gum

Completed·FFertin Pharma A/S·Phase 1·NCT02356913·15 enrolled

Trial1 trial

QuitAid Pilot Feasibility Trial

Completed·UUniversity of Virginia·N/A·NCT05649241·24 enrolled

ESS1 trial

Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT05758298

Whitening1 trial

A Pilot Drug Trial That Evaluates the Whitening Potential of Nicotine Gum

Completed·MMcNeil AB·Phase 4·NCT00174499·78 enrolled

TED1 trial

Evaluation of Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes

Completed·222nd Century Group, Inc.·Phase 1·NCT03559725·55 enrolled

Interaction1 trial

Evaluating the Pharmacokinetics and Drug Interaction Potential of the Botanical Dietary Supplement Cinnamon

Unknown status·WWashington State University·Phase 1·NCT05157672·16 enrolled

Attention1 trial

Effects of Nicotine and Attention on Frequency Tuning in Auditory Cortex

Recruiting·UUniversity of California, Berkeley·Phase 1·NCT05018117·48 enrolled

Tobacco Dependence1 trial

Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2/3·NCT01208935·157 enrolled

AIN1 trial

Studying the Role of Brain Molecules for Decision Making

Completed·UUniversity of Zurich·N/A·NCT04384562·160 enrolled

Smoking1 trial

Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

Completed·WWake Forest University Health Sciences·N/A·NCT05030272·343 enrolled

Smoking Reduction1 trial

Smoking Reduction or Cessation With Nicotine Replacement Therapy

Completed·MMcNeil AB·Phase 3·NCT00840242·314 enrolled

Efficacy1 trial

Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

Completed·UUniversity of Minnesota·Phase 2·NCT00710034·391 enrolled

Unspecified1 trial

Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes

Completed·222nd Century Group, Inc.·Phase 1·NCT03559751·66 enrolled

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Nicotine gum. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nicotine gum compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nicotine gum. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

Nicotine gum

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q3 2030

Trials by Indication[1]

Oral4 trials

Smoking Cessation4 trials

Smokers2 trials

Treatment2 trials

Effectiveness1 trial

Tobacco Cessation1 trial

Colorectal Surgery1 trial

MPA1 trial

Trial1 trial

ESS1 trial

Whitening1 trial

TED1 trial

Interaction1 trial

Attention1 trial

Tobacco Dependence1 trial

AIN1 trial

Smoking1 trial

Smoking Reduction1 trial

Efficacy1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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