Nicorette

(Nicotine)

ApprovedSmall molecule

Nicotine is used to help people quit smoking by reducing cravings and withdrawal symptoms when they stop using tobacco products. It's available in forms like patches, gum, lozenges, and inhalers that deliver nicotine without the harmful chemicals in cigarette smoke.[2] Nicorette is currently approved and in use across 37 indications[4].[1]

Nicorette is one of 593 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

302

Total Trials

Active Trials

592

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Nicotine DependenceCompleted

Depressive DisorderCompleted

Post Operative Nausea and VomitingApproved

Wound HealingActive, not recruiting

Psychiatric DisorderActive, not recruiting

Lung CancerCompleted

Attention Deficit Hyperactivity DisorderApproved

Acute Coronary SyndromeActive, not recruiting

Schizoaffective DisorderTerminated

Coronary Artery DiseasePreclinical

Active, not recruiting

Nicotine DependenceApproved

Completed

Depressive DisorderApproved

Completed

Post Operative Nausea and VomitingApproved

Approved

Wound HealingPreclinical

Active, not recruiting

Psychiatric DisorderApproved

Active, not recruiting

Lung CancerApproved

Completed

Attention Deficit Hyperactivity DisorderApproved

Approved

Acute Coronary SyndromePreclinical

Active, not recruiting

Schizoaffective DisorderApproved

Terminated

Showing 10 of 36 indications

Competition

Competitive Landscape

199 competitors in Lung Cancer

#DrugCompanyPhaseTrials

Imfinzi

AstraZeneca

Phase 3

25 2

Opdivo

Bristol-Myers Squibb

Phase 3

20 3

Nicorette

Pfizer

Approved

2 4

Beyfortus

BeiGene

Phase 3

10 5

Yervoy

Bristol-Myers Squibb

Phase 3

10 6

Abraxane

Bristol-Myers Squibb

Phase 3

7 7

Tecentriq

Roche

Phase 3

6 8

Alecensa

Roche

Phase 3

3 9

Zepzelca

Jazz Pharmaceuticals

Phase 3

3 10

DATROWAY

Daiichi Sankyo

Phase 3

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Thoracic Surgery

NCT07250230

Q1 2027

Phase 1Recruiting

Study completion

NCT06096714

Phase 1Active, not recruiting

Lung Cancer

NCT04200534

Phase 1Recruiting

Smoking

NCT05665465

Q1 2028

N/AActive, not recruiting

Cervical Cancer

NCT05645146

Q2 2028

Phase 3Recruiting

Smoking Cessation

NCT06053567

Clinical

Trials by Indication[1]

Smoking Cessation44 trials

Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)

Completed·—·N/A·NCT01055886·69 enrolled

Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

Completed·UUniversity of Maryland, College Park·Phase 3·NCT01351766·39 enrolled

Combination Nicotine Patch / Lorcaserin for Smoking Cessation

Completed·—·Phase 2·NCT02906644·97 enrolled

Show 41 more trials

Metabolism-informed Care for Smoking Cessation

Completed·VVanderbilt University Medical Center·N/A·NCT03227679·82 enrolled

Nicotine Patch Pretreatment for Smoking Cessation in PTSD

Completed·UUS Department of Veterans Affairs·Phase 1·NCT00625131·87 enrolled

Coping Skills Treatment for Smoking Cessation

Completed·—·N/A·NCT01061528·116 enrolled

Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation

Completed· GSK logo

GSK·Phase 3·NCT00985985·723 enrolled

Smoking Cessation After Hospitalization for a Cardiopulmonary Illness

Completed·—·N/A·NCT01791803·164 enrolled

Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers

Completed·UUniversity of Oulu·Phase 4·NCT03235505·450 enrolled

The Use of Nicotine Patches Together With E-cigarettes (With and Without Nicotine) for Smoking Cessation

Completed·UUniversity of Auckland, New Zealand·Phase 3·NCT02521662·1,124 enrolled

Impact of Smoking Cessation on Sleep - 5

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 4·NCT00132821·59 enrolled

Combinations of Pharmacologic Smoking Cessation Treatments

Completed·UUS Department of Veterans Affairs·Phase 1·NCT00018187

Assessment of a Teachable Moment for Smoking Cessation

Completed·UUniversity of Pennsylvania··NCT00596440·234 enrolled

Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

Completed·MMaggie M Sweitzer, PhD·Phase 1/2·NCT02927847·35 enrolled

Opioids and Smoking Cessation

Withdrawn·UUniversity of Houston·Phase 4·NCT03857139

Extended Treatment for Smoking Cessation

Completed·SStanford University·Phase 4·NCT01330043·223 enrolled

iQuit Mindfully: Text Messaging for Smoking Cessation

Completed·GGeorgia State University·N/A·NCT03029819·72 enrolled

Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.

Recruiting·—·Phase 3·NCT06053567·360 enrolled

Heart Rate Variability Biofeedback for Smoking Cessation

Completed·RRutgers, The State University of New Jersey·Phase 2·NCT03972137·10 enrolled

UW-CTRI Triple Medication Smoking Cessation Study

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT02681510·36 enrolled

Text Messaging for Smoking Cessation in College Health Clinics

Completed·YYale University·N/A·NCT02191033·40 enrolled

Smoking Cessation Intervention

Terminated·UUniversity of Florida·Phase 4·NCT03072511·23 enrolled

Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy

Completed·NNational Institute on Drug Dependence, China·Phase 4·NCT01980550·250 enrolled

Enhancing a High School Based Smoking Cessation Program

Completed·YYale University·N/A·NCT01145001·154 enrolled

Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

Completed·RRoswell Park Cancer Institute·N/A·NCT01771627·300 enrolled

Concurrent Bupropion / Varenicline for Smoking Cessation

Completed·—·Phase 3·NCT01303861·702 enrolled

Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT00235313·300 enrolled

An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS (Project Legacy)

Withdrawn·MM.D. Anderson Cancer Center·N/A·NCT02029612

Study on the Model of Smoking Cessation Intervention and Service Ability Improvement

Unknown status·—··NCT01935505·2,000 enrolled

Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy

Completed·YYale University·Phase 2·NCT00699556·22 enrolled

Smoking Cessation and Sexual Health in Men

Completed·UUniversity of Texas at Austin·Phase 1·NCT00833404·80 enrolled

Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease

Completed·OOttawa Heart Institute Research Corporation·Phase 4·NCT00959972·50 enrolled

Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

Completed·UUConn Health·Phase 2·NCT01484717·90 enrolled

Evaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study)

Completed·UUniversity of Tennessee·N/A·NCT00632411·1,298 enrolled

Pager-Assisted Smoking Cessation Treatment

Completed·UUniversity of California, San Francisco·N/A·NCT01207310·224 enrolled

Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT00332644·1,504 enrolled

Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)

Completed·RRutgers, The State University of New Jersey·N/A·NCT03873337·34 enrolled

Meclizine as a Potential Smoking Cessation Treatment

Completed·—·Phase 2·NCT01443858·146 enrolled

Innovative Interventions for Smoking Cessation

Completed·UUniversity of Minnesota·Phase 2·NCT01050569·235 enrolled

Smoking Cessation Treatment for Head and Neck Cancer Patients

Terminated·YYale University·Phase 1·NCT00931021·7 enrolled

Exenatide for Smoking Cessation and Prevention of Weight Gain

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT05610800·140 enrolled

Varenicline and Combined NRT for Smoking Cessation

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 4·NCT02271919·631 enrolled

Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

Completed·—·Phase 1·NCT03069482·63 enrolled

Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

Completed·YYale University·N/A·NCT01259466·54 enrolled

Treatment11 trials

Nicotine Delivery Systems: Research & Treatment

Terminated·UUS Department of Veterans Affairs·N/A·NCT00108342·25 enrolled

Motivation and Nicotine Patch Treatment for Under-served Smokers

Completed·TThe Miriam Hospital·N/A·NCT01684995

Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer

Completed·EEastern Cooperative Oncology Group·N/A·NCT00002520·434 enrolled

Show 8 more trials

Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

Completed·—·N/A·NCT00790569·315 enrolled

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

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

Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

Completed·UUniversity of Maryland, College Park·Phase 1/2·NCT01372254·96 enrolled

Smoking Treatment and Exercise Program for Underserved Populations (STEP UP)

Completed·—·N/A·NCT02873754·11 enrolled

Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement

Terminated·CCentre for Addiction and Mental Health·Phase 2/3·NCT02439944·18 enrolled

Identifying Treatments to Motivate Smokers to Quit

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

Treatment to Quit Smoking

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00018161

Tobacco Treatment Comparison for Cancer Care

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT06218823·52 enrolled

Smoking10 trials

Offering Nicotine Patches to All Households in a Municipality With High Smoking Rates

Completed·CCentre for Addiction and Mental Health··NCT04534231·123 enrolled

Post Acute Coronary Event Smoking Study

Completed·TThe Miriam Hospital·N/A·NCT01964898·65 enrolled

Effects of Smoking on Opioid Receptor Binding: A PET Study

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00618631·26 enrolled

Show 7 more trials

A Quit Smoking Study Using Smartphones

Completed·UUniversity of Wisconsin, Madison·N/A·NCT02164383·30 enrolled

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

Completed·FFox Chase Cancer Center·Phase 4·NCT00365508·642 enrolled

Smoking Termination Enhancement Project (STEP)

Completed·UUnknown Sponsor·Phase 3·NCT01065506·150 enrolled

Women Engaging in Quitting Smoking Together

Completed·RRhode Island Hospital·N/A·NCT02453659·100 enrolled

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

Recruiting·—·Phase 1·NCT05665465·150 enrolled

Completed·MMclean Hospital·N/A·NCT01588561·15 enrolled

Effects of Smoking Environments on Craving and Smoking (CameraCue2.0)

Completed·—·N/A·NCT02551692·125 enrolled

Oral8 trials

Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum

Completed·MMcNeil AB·N/A·NCT01368016·346 enrolled

Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

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

Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

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

Show 5 more trials

Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum

Completed·MMcNeil AB·N/A·NCT01152723·28 enrolled

Behavioral Economics of Human Drug Self-Administration

Completed·NNational Center for Research Resources (NCRR)··NCT00005765

Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

Completed·MMcNeil AB·Phase 1·NCT01321931·50 enrolled

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

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

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

Completed·MMcNeil AB·N/A·NCT01084603·45 enrolled

Smokers8 trials

Electronic Cigarettes in Daily Dependent Smokers

Completed·CCentre for Addiction and Mental Health·Phase 4·NCT02108626·43 enrolled

A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers

Completed· GSK logo

GSK·Phase 1·NCT01702519·40 enrolled

Nicotine Reinforcement and Aversion in Young Adult Light Smokers

Completed·YYale University·Phase 1·NCT01495819·34 enrolled

Show 5 more trials

Very Low-Nicotine Cigarettes in Smokers With SUD

Completed·—·Phase 2·NCT01989507·250 enrolled

Naltrexone and Patch for Smokers

Completed·UUS Department of Veterans Affairs·N/A·NCT00018213

Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers

Completed·JJed E. Rose·Phase 2·NCT01926626·76 enrolled

Nicotine, Non-Smokers With and Without ADHD, and Genetics Study

Completed·—·Phase 1·NCT01819259·136 enrolled

Development of a mHealth Intervention for Ambivalent Smokers

Completed·KKaiser Permanente·Phase 1·NCT04560868·57 enrolled

72 more indications

Effectiveness6 trials

Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers

Completed·SSouthern Illinois University Carbondale·Phase 4·NCT01048944·197 enrolled

A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline

Completed·UUniversity of Colorado, Denver·N/A·NCT01889771·1,495 enrolled

A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT01553084·1,086 enrolled

Show 3 more trials

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

Long-term Effectiveness of Mailed Nicotine Replacement Therapy: A 5-year Follow-up

Completed·CCentre for Addiction and Mental Health·N/A·NCT03097445·1,000 enrolled

Effectiveness of Different THR Products in Adult Population

Unknown status·FFoundation for a Smoke Free World INC·Phase 3·NCT05825924·258 enrolled

Schizophrenia6 trials

5HT3 Antagonism and Auditory Gating in Schizophrenia

Completed·UUS Department of Veterans Affairs·N/A·NCT00018850

Nicotinic Modulation of Schizophrenia-like Information Processing Deficits in Healthy Subjects

Completed·YYale University·Phase 1·NCT00690170·30 enrolled

Nicotine Effects on Endophenotypes of Schizophrenia

Completed·UUniversity Hospital, Bonn·N/A·NCT01315002·121 enrolled

Show 3 more trials

Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00218218·48 enrolled

Effect of Nicotine Transdermal Patch on Cognitive Function and Glycolipid Metabolism in Non-smoking Schizophrenia

Unknown status·SSir Run Run Shaw Hospital·Phase 1·NCT05301660·80 enrolled

E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

Completed·TThe University of Texas Health Science Center, Houston·N/A·NCT02918630·7 enrolled

Craving4 trials

Provoked Craving Relief Study by NRT

Completed· GSK logo

GSK·Phase 2·NCT01476202·120 enrolled

Nicotine Mouth Film for Craving Relief.

Completed· GSK logo

GSK·Phase 3·NCT01702532·320 enrolled

Control Systems Approach to Predicting Individualized Dynamics of Nicotine Cravings

Unknown status·SStony Brook University·N/A·NCT02643914·23 enrolled

Show 1 more trial

Provoked Craving Assessment

Completed· GSK logo

GSK·Phase 2·NCT01506908·323 enrolled

Nicotine Dependence4 trials

Group Therapy for Nicotine Dependence: Mindfulness and Smoking

Completed·MM.D. Anderson Cancer Center·N/A·NCT00297479·650 enrolled

Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging

Completed·JJohns Hopkins University·Phase 4·NCT01664741·127 enrolled

An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence

Completed·UUniversity of Pennsylvania·Phase 4·NCT01047527·525 enrolled

Show 1 more trial

Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00124683·59 enrolled

Attention3 trials

Effects of Prazosin on the Attention-Enhancing Effects of Nicotine

Withdrawn·UUniversity of Maryland, Baltimore·N/A·NCT03416569

The Use of AVL-3288 to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine

Withdrawn·UUniversity of Maryland, Baltimore·Phase 1·NCT03281694

Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking

Completed·MM.D. Anderson Cancer Center·N/A·NCT02224391·311 enrolled

Lozenge3 trials

Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge

Completed·MMcNeil AB·Phase 2·NCT01075659·200 enrolled

Pharmacokinetic Study of 4 mg Nicotine Lozenge.

Completed· GSK logo

GSK·Phase 2·NCT01669122·40 enrolled

Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge

Completed·PPharmaceutical Productions Inc.·Phase 1·NCT01887847·6 enrolled

Tobacco3 trials

Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study)

Completed·QQueen Mary University of London·Phase 3·NCT01184664·117 enrolled

Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

Completed·UUniversity of Miami·Phase 4·NCT02511236·356 enrolled

Smoking Tobacco and Drinking Study

Completed·UUniversity of California, San Francisco·Phase 4·NCT03163303·179 enrolled

Biomarkers3 trials

Analysis of Aldehyde Biomarkers of Exposure and Host Response

Terminated·UUniversity of Nebraska·N/A·NCT00482690·35 enrolled

Validation of Biomarkers of Exposure and Host Response

Completed·UUniversity of Nebraska·N/A·NCT00468234·60 enrolled

Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05136690·38 enrolled

Parkinson's Disease3 trials

Nicotine Treatment of Impulsivity in Parkinson's Disease

Unknown status·UUniversity of Vermont·Phase 4·NCT01216904·20 enrolled

Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT00873392·40 enrolled

Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease

Unknown status·JJames BOYD MD·Phase 2·NCT01560754·160 enrolled

Adolescent2 trials

Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2

Completed·YYale University·Phase 1·NCT03168191·56 enrolled

Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1

Completed·YYale University·Phase 1·NCT02179034·59 enrolled

Tobacco Use Cessation2 trials

Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya

Completed·UUniversity of California, San Francisco·Phase 4·NCT05351606·580 enrolled

Adapting and Evaluating a Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia

Recruiting·UUniversity of Southern California·Phase 1·NCT05487807·800 enrolled

MPA2 trials

An Exploratory Study Comparing Two Nicotine Inhalers

Completed·MMcNeil AB·Phase 1·NCT01478230·36 enrolled

Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

Completed· GSK logo

GSK·Phase 1·NCT01847443·84 enrolled

Pilot Study2 trials

Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study

Terminated·MM.D. Anderson Cancer Center·N/A·NCT02302859·8 enrolled

Pilot Study of Nicotine Nasal Spray and Varenicline on Smoking in Methadone-Maintained Patients

Terminated·UUniversity of Cincinnati·Phase 4·NCT02147132·7 enrolled

Adult2 trials

Nicotine and Behavior in Adult ADHD

Completed·UUniversity of California, Irvine·N/A·NCT00573248·78 enrolled

Effects of E-Cigarette Flavors on Adults TCORS 2.0

Completed·YYale University·Phase 1·NCT03635333·130 enrolled

Efficacy and Safety2 trials

Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

Completed·MMcNeil AB·N/A·NCT00882375·479 enrolled

Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy

Completed·MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.·Phase 3·NCT02355665·1,198 enrolled

Irritation2 trials

Photoirritation and Photoallergic Potential of a New Nicotine Patch

Completed·MMcNeil AB·Phase 1·NCT00966901·43 enrolled

Cumulative Skin Irritation Potential of a New 25 mg Nicotine Patch

Completed·MMcNeil AB·Phase 1·NCT00967174·42 enrolled

Cognition2 trials

Effects of Exercise and Nicotine on Cognition in Smokers

Completed·WWestern University, Canada·Phase 3·NCT03091699·34 enrolled

Cognition and Smoking Relapse (HCS)

Completed·UUniversity of Pennsylvania··NCT03169101·274 enrolled

Depressed2 trials

Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)

Completed·VVanderbilt University Medical Center·Phase 4·NCT02816138·15 enrolled

Depressed Mood Improvement Through Nicotine Dosing 2

Completed·VVanderbilt University Medical Center·Phase 2·NCT04433767·29 enrolled

Cognitive impairment2 trials

Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study

Completed·VVanderbilt University Medical Center·Phase 2·NCT02312934·22 enrolled

Nicotine Treatment of Mild Cognitive Impairment (MCI)

Unknown status·NNational Institute on Aging (NIA)·Phase 1·NCT00091468·75 enrolled

Tobacco Cessation2 trials

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

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

Mobile Contingency Management for Marijuana and Tobacco Cessation

Completed·—·N/A·NCT02869451·7 enrolled

Smoking Reduction2 trials

Smoking Reduction or Cessation With Nicotine Replacement Therapy

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

Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong

Completed·—·Phase 4·NCT03879889·210 enrolled

Kaposi's sarcoma1 trial

Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00295984·24 enrolled

Tobacco Use1 trial

The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users

Completed·YYale University·N/A·NCT02102100·57 enrolled

Psychiatric Disorder1 trial

Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders

Withdrawn·HHospital Universitari Vall d'Hebron Research Institute·Phase 4·NCT03809897

Progesterone1 trial

Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect

Withdrawn·MMclean Hospital·N/A·NCT01589081

Humans1 trial

Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans

Completed·YYale University·Phase 1·NCT02018263·5 enrolled

Acute1 trial

Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine: Electronic Cigarette and Cigarette

Completed·PParc de Salut Mar·Phase 1·NCT02511704·12 enrolled

Withdrawal1 trial

Nicotine Patch for Marijuana Withdrawal

Completed·SSouthern Illinois University Carbondale·Phase 4·NCT01400243·127 enrolled

Third Molar Surgery1 trial

Nicotine as an Adjuvant Analgesic for Third Molar Surgery

Completed·—·Phase 4·NCT00385216·20 enrolled

Tooth Staining1 trial

A Study on the Effects of Two Nicotine Replacement Products on Tooth Staining

Completed·MMcNeil AB·N/A·NCT01440985·200 enrolled

Vascular Function1 trial

Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

Unknown status·UUniversity of Athens·Phase 4·NCT02307045·600 enrolled

Virtual Reality1 trial

Nicotine Virtual Reality Conditioned Place Preference

Withdrawn·UUniversity of Chicago·Phase 4·NCT06259630

Addiction1 trial

Do Flavors Increase the Addiction Potential of Nicotine?

Completed·UUniversity of Vermont·Phase 2·NCT04696380·19 enrolled

Schizoaffective Disorder1 trial

Nicotine Patch for Nicotine Dependence in Individuals With Schizophrenia or Schizoaffective Disorder - 1

Terminated·NNational Institute on Drug Abuse (NIDA)·Phase 4·NCT00046813·100 enrolled

Smoking Behavior1 trial

Effects of Menthol in E-cigarettes on Smoking Behaviors

Completed·YYale University·Phase 1·NCT04521647·10 enrolled

Idiopathic Parkinson's Disease1 trial

Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa Therapy

Completed·NNeuraltus Pharmaceuticals, Inc.·Phase 1/2·NCT00957918·65 enrolled

Intravenous1 trial

Sensitivity to Intravenous Nicotine: Genetic Moderators

Completed·YYale University·Phase 1·NCT00969137·213 enrolled

TIA1 trial

Nicotine's Potential Abuse With Menthol

Completed·YYale University·Phase 1·NCT04535362·16 enrolled

Opioid1 trial

Effects of Nicotine on Brain Opioid Receptors

Terminated·UUniversity of Pennsylvania··NCT01040338·15 enrolled

Recurrence1 trial

Comparison of Nicotine Inhaler and/or Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00033592·1,708 enrolled

Vaping1 trial

Vaping THC From Electronic Cigarettes

Completed·UUniversity of California, San Francisco·Phase 3·NCT02955329·8 enrolled

Non-Small Cell Lung Cancer1 trial

S0002 - A Program to Quit Smoking With or Without Bupropion in Treating Patients With Stage I or II Non-Small Cell Lung Cancer Who Have Undergone Surgery

Terminated·SSWOG Cancer Research Network·Phase 3·NCT00032084·10 enrolled

Magnetic Resonance Imaging1 trial

Functional Magnetic Resonance Imaging (fMRI) Investigation of Nicotine Withdrawal Symptoms

Completed· GSK logo

GSK·Phase 4·NCT00657020·23 enrolled

Cancer1 trial

Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer

Withdrawn·MMayo Clinic·N/A·NCT00425906

Cervical Cancer1 trial

Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·N/A·NCT05645146·360 enrolled

Intensive Care Unit1 trial

Nicotine Replacement Therapy in the Intensive Care Unit

Completed·—·Phase 4·NCT01362959·47 enrolled

Analgesic1 trial

Nicotine Patch as an Analgesic Adjuvant After Surgery

Completed·—·Phase 4·NCT00440830·68 enrolled

Randomized Controlled Trial1 trial

A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care for Homeless Smokers

Completed·MMassachusetts General Hospital·N/A·NCT02565381·83 enrolled

Postoperative Pain Relief1 trial

Preemptive Use of the Nicotine Patch for Postoperative Pain Relief After Open Abdominal Surgery

Terminated·SStony Brook University·N/A·NCT00790829·30 enrolled

Peripheral Neuropathy1 trial

Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy

Terminated·VVirginia Commonwealth University·Phase 2·NCT04468230·4 enrolled

Lung Cancer1 trial

Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04200534·358 enrolled

Wound Healing1 trial

Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing

Completed·—·N/A·NCT00825851·78 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

Bariatric Surgery1 trial

Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery

Completed·TToby Weingarten·Phase 4·NCT01194089·95 enrolled

Critically Ill Patients1 trial

Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

Completed·UUniversity Hospital Ostrava·N/A·NCT03847155·52 enrolled

Relapse1 trial

Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)

Completed·FFrancis McClernon, Ph.D.·N/A·NCT02538042·87 enrolled

Imaging1 trial

PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nicotine.

Recruiting·SStony Brook University·Phase 4·NCT07095205·14 enrolled

Thoracic Surgery1 trial

Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Undergoing Thoracic Surgery: A Randomized Controlled Pilot Study

Recruiting·HHenan Provincial People's Hospital·N/A·NCT07250230·80 enrolled

Oxidative Stress1 trial

Nicotine Patch, Blood Flow and Oxidative Stress Study

Completed·UUniversity of Pennsylvania·N/A·NCT00954096·55 enrolled

Skin1 trial

Skin Sensitization Potential of a New Nicotine Patch

Completed·MMcNeil AB·Phase 1·NCT00967070·257 enrolled

Physical Activity1 trial

Increasing Physical Activity as Part of a Smoking Cessation Program

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·N/A·NCT00403312·400 enrolled

Trial1 trial

QuitAid Pilot Feasibility Trial

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

Chronic Obstructive Pulmonary Disease1 trial

Nurse Smoking Cessation of Patients With Chronic Obstructive Pulmonary Disease (COPD) With Nicotine Replacement Therapy (NRT) and Behavioral Support

Terminated·UUniversity Hospital, Gentofte, Copenhagen·Phase 3·NCT00132236·300 enrolled

Anxiety1 trial

Smoking Termination / Anxiety Reduction Treatment (ST/ART)

Completed·UUniversity of Houston·Phase 1·NCT01789125·74 enrolled

Acute Coronary Syndrome1 trial

The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome

Suspended·SSir Mortimer B. Davis - Jewish General Hospital·N/A·NCT00990197·30 enrolled

Function1 trial

IV Nicotine Induced Changes in Hormone Function, Mood States and Behavior

Withdrawn·MMclean Hospital·N/A·NCT01589055

Nicotine Withdrawal1 trial

Nicotine Withdrawal Symptoms and Smoking Relapse

Completed·NNational Institute on Drug Abuse (NIDA)·N/A·NCT01511614·112 enrolled

AIN1 trial

Brain Nicotine Receptor Density & Response to Nicotine Patch

Completed·—··NCT01526005·50 enrolled

Vomiting1 trial

Transdermal Nicotine in Female Patients at High Risk for Post Operative Nausea and/or Vomiting (PONV)

Withdrawn·OOchsner Health System·N/A·NCT00775749

Sarcoidosis1 trial

Study of Nicotine Patches in Patients With Sarcoidosis

Completed·—·Phase 1·NCT00701207·64 enrolled

Autism1 trial

Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism

Completed·YYale University·Phase 1·NCT02552147·8 enrolled

Unspecified10 trials

E-cigarette Nicotine Study

Completed·UUniversity of Vermont·Phase 2·NCT04709471·77 enrolled

Addictive Threshold of Nicotine

Recruiting·YYale University·Phase 1·NCT06096714·36 enrolled

Nicotine and Pavlovian Bias

Unknown status·UUniversity of Southern California·Phase 1·NCT06027723·40 enrolled

Show 7 more trials

4 mg Nicotine Polacrilex Gum and Swedish Portion Snus

Completed·CContract Research Organization el AB·Phase 1/2·NCT01182129·15 enrolled

Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

Completed·MMcNeil AB·N/A·NCT01113424·88 enrolled

Effects of E-cigarette Flavors on Youth TCORS 2.0

Completed·YYale University·Phase 1·NCT03634839·42 enrolled

Nicotine Patch - Multidose Bioequivalence Study

Completed·PPierre Fabre Medicament·Phase 1·NCT01658215·43 enrolled

Nicotine Patch Safety Study

Completed·PPierre Fabre Medicament·Phase 2·NCT01655082·160 enrolled

Personalized Dosing of Nicotine Replacement (NRT to Effect)

Completed·CCentre for Addiction and Mental Health·Phase 4·NCT03000387·211 enrolled

Nicotine Replacement Therapy in Nicotine-dependent Arrestees

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT02905734·800 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 22, 1996

NICOTROL

NDA NDA020385

Jul 3, 1996

NICOTROL

NDA NDA020536

Aug 2, 1996

NICODERM CQ

NDA NDA020165

May 2, 1997

NICOTROL

NDA NDA020714

Dec 23, 1998

PROSTEP

NDA NDA019983

Nov 12, 1999

HABITROL

NDA NDA020076

Sources

References

[1]
ClinicalTrials.gov — 302 trial records for Nicotine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nicorette drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nicotine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nicotine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020076). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Neuronal Acetylcholine Receptor; Alpha4/beta2 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer