Nicotine lozenge

Phase 3Small molecule

FFertin Pharma A/S

Nicotine lozenge is one of 220 small molecule programs targeting Smoking Cessation. It is currently in Phase 3.

Indications

Total Trials

Active Trials

219

Competitors

Pipeline

Status by Indication[3][1]

Indication

Smoking CessationCompleted

Cervical CancerActive, not recruiting

SchizophreniaActive, not recruiting

Cigarette Smoking-Related CarcinomaNot yet recruiting

BiomarkersTerminated

WithdrawalCompleted

ChildrenCompleted

SmokersCompleted

Tobacco CessationCompleted

LiverActive, not recruiting

Smoking CessationPhase 3

Completed

Cervical CancerPreclinical

Active, not recruiting

SchizophreniaPreclinical

Active, not recruiting

Cigarette Smoking-Related CarcinomaPhase 3

Not yet recruiting

BiomarkersPreclinical

Terminated

WithdrawalPreclinical

Completed

ChildrenPreclinical

Completed

SmokersPreclinical

Completed

Tobacco CessationPreclinical

Completed

LiverPreclinical

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

206 competitors in Lung Cancer

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

33 2

Imfinzi

AstraZeneca

Phase 3

25 3

Tagrisso

AstraZeneca

Phase 3

19 4

Yervoy

Bristol-Myers Squibb

Phase 3

10 5

Beyfortus

BeiGene

Phase 3

10 6

Abraxane

Bristol-Myers Squibb

Phase 3

7 7

Tecentriq

Roche

Phase 3

6 8

Alunbrig

Takeda

Phase 3

4 9

DATROWAY

Daiichi Sankyo

Phase 3

2 10

Ilaris

Novartis

Phase 3

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

Timeline

Expected Milestones

Q3 2026

N/AActive, not recruiting

Treatment

NCT05014282

Q4 2026

Post-ApprovalActive, not recruiting

Lung Cancer

NCT03315910

N/AActive, not recruiting

Smoking Cessation

NCT05290025

Q1 2028

N/AActive, not recruiting

Cervical Cancer

NCT05645146

Q2 2029

Phase 2Recruiting

Smoking Cessation

NCT07099638

Clinical

Trials by Indication[1]

Smoking Cessation14 trials

Inpatient Smoking Cessation Pilot Program

Withdrawn·JJohns Hopkins University·Phase 1·NCT05060965

Persistence-Targeted Smoking Cessation

Completed·RRutgers, The State University of New Jersey·Phase 1·NCT01654107·58 enrolled

e-Cigarettes Versus NRT Gum for Smoking Cessation

Terminated·—·Phase 4·NCT01925781·10 enrolled

Show 11 more trials

Development of Positive Psychotherapy for Smoking Cessation

Completed·—·Phase 2·NCT01451814·66 enrolled

Adaptive Pharmacotherapy for Smoking Cessation

Completed·—·Phase 2·NCT02501265·188 enrolled

Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype

Completed·—·Phase 3·NCT00894166·606 enrolled

Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

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

Smoking Cessation for Cervical Cancer Survivors

Completed·HH. Lee Moffitt Cancer Center and Research Institute·N/A·NCT02157610·202 enrolled

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

Completed·—·Phase 1·NCT03069482·63 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

Varenicline and Combined NRT for Smoking Cessation

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

Smoking Cessation Intervention: Effectiveness in Primary Care

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT00296647·1,346 enrolled

Randomized Factorial Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention to Promote Smoking Cessation

Recruiting·UUniversity of Oklahoma·Phase 2·NCT07099638·496 enrolled

Partnering With a State Food Bank to Provide Tobacco Treatment to Underserved Smokers (Project NOURISH)

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Preclinical·NCT05004662·502 enrolled

Lozenge3 trials

Single-Dose Bioequivalence Study Comparing Two 4 mg Nicotine Lozenges

Completed·FFertin Pharma A/S·Phase 1·NCT03432312·42 enrolled

Comparing NicoBloc to Nicotine Lozenges

Completed·UUniversity of Alabama at Birmingham·Phase 2/3·NCT03720899·45 enrolled

Single-Dose Bioequivalence Study Comparing Two 2 mg Nicotine Lozenges

Completed·FFertin Pharma A/S·Phase 1·NCT03432273·42 enrolled

Treatment3 trials

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

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

Nicotine Replacement Treatment for Pregnant Smokers - 1

Terminated·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00115687·250 enrolled

Automated Video-Assisted Smoking Treatment for People Living With HIV

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·N/A·NCT05014282·638 enrolled

Biomarkers2 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

Nicotine Dependence2 trials

Extinction Based Treatment for Nicotine Dependence

Completed·—·Phase 1·NCT00831155·257 enrolled

Methadone-Maintained Smokers Switching to E-Cigarettes

Completed·BButler Hospital·Approved·NCT05206435·183 enrolled

23 more indications

Children2 trials

Preliminary Investigation of Novel Methods to Reduce Children's Secondhand Smoke Exposure

Completed·UUniversity of Oklahoma·N/A·NCT01935713·89 enrolled

Novel Methods to Reduce Children's Secondhand Smoke Exposure II

Completed·UUniversity of Oklahoma·N/A·NCT01896518·74 enrolled

Smoking2 trials

Effects of Contingency Management and Nicotine Replacement Therapy on Youth Smoking

Completed·UUniversity of California, Los Angeles·Phase 1·NCT01359709·60 enrolled

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

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

Oral2 trials

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

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

Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

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

Mental Illness1 trial

Treating Smokers With Mental Illness

Completed·UUniversity of Minnesota·Phase 2·NCT03822416·38 enrolled

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

Chronic1 trial

Acute and Chronic Nicotine Modulation of Reinforcement Learning

Completed·—·N/A·NCT01830842·54 enrolled

Schizophrenia1 trial

Effects of Acute Nicotine Treatment on Neuroplasticity and Memory in Patients With Schizophrenia

Terminated·CCentre for Addiction and Mental Health·N/A·NCT01465074·20 enrolled

Smokers1 trial

RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers

Completed·MMontefiore Medical Center·N/A·NCT02781090·512 enrolled

AIN1 trial

Effect of Nicotine on Brain Reward Pathways

Completed·MMclean Hospital·Phase 1·NCT02346539·46 enrolled

Preoperative1 trial

Pilot Study: Preoperative Nicotine Lozenges

Completed·MMayo Clinic·Phase 4·NCT00586482·46 enrolled

Lung Cancer1 trial

Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 4·NCT03315910·807 enrolled

Tobacco Cessation1 trial

Mobile Contingency Management for Marijuana and Tobacco Cessation

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

Smokeless Tobacco1 trial

Nicotine Lozenge to Reduce Smokeless Tobacco Use

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00218283·100 enrolled

Liver1 trial

Feasibility of Delivering VergeRx at FQHCs

Active, not recruiting·UUniversity of Virginia·N/A·NCT06161675·100 enrolled

Effectiveness1 trial

A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

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

Withdrawal1 trial

Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

Completed·UUniversity of Minnesota·N/A·NCT01522963·98 enrolled

Tobacco Use Cessation1 trial

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

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

MPA1 trial

Comparisons of Nicotine-free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00777569·66 enrolled

Single Dose1 trial

A Single Dose Bioequivalence Study OfTwo Formulations Of Nicotine Lozenges

Completed· GSK logo

GSK·Phase 1·NCT00651352·32 enrolled

Craving1 trial

Medicinal Nicotine for Preventing Cue Induced Craving

Completed·UUniversity of Minnesota·N/A·NCT02347605·56 enrolled

Cigarette Smoking-Related Carcinoma1 trial

Providing Nicotine Replacement Therapy to Enhance the Efficacy of a Smoking Cessation Smartphone App for Hispanic Adults

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

Cigarette Smoking1 trial

Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices

Completed·HHennepin Healthcare Research Institute·Phase 2·NCT05627596·1,239 enrolled

Unspecified1 trial

Babies Living Safe and Smokefree

Completed·TTemple University·N/A·NCT02602288·396 enrolled

Sources

References

[1]
ClinicalTrials.gov — 50 trial records for Nicotine lozenge. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nicotine lozenge compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nicotine lozenge. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Fertin Pharma A/S company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: FFertin Pharma A/S

Nicotine lozenge

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2028

Q2 2029

Trials by Indication[1]

Smoking Cessation14 trials

Lozenge3 trials

Treatment3 trials

Biomarkers2 trials

Nicotine Dependence2 trials

Children2 trials

Smoking2 trials

Oral2 trials

Mental Illness1 trial

Cervical Cancer1 trial

Chronic1 trial

Schizophrenia1 trial

Smokers1 trial

AIN1 trial

Preoperative1 trial

Lung Cancer1 trial

Tobacco Cessation1 trial

Smokeless Tobacco1 trial

Liver1 trial

Effectiveness1 trial

Withdrawal1 trial

Tobacco Use Cessation1 trial

MPA1 trial

Single Dose1 trial

Craving1 trial

Cigarette Smoking-Related Carcinoma1 trial

Cigarette Smoking1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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