Last reviewed 2026-04-22 · How we verify

Nicotine Mini-Lozenge

University of Wisconsin, Madison · FDA-approved active Small molecule

Nicotine Mini-Lozenge is a Nicotine replacement therapy (NRT) Small molecule drug developed by University of Wisconsin, Madison. It is currently FDA-approved for Smoking cessation aid, Reduction of nicotine withdrawal symptoms.

Nicotine mini-lozenges deliver nicotine through oral mucosal absorption to reduce cravings and withdrawal symptoms during smoking cessation.

Nicotine mini-lozenges deliver nicotine through oral mucosal absorption to reduce cravings and withdrawal symptoms during smoking cessation. Used for Smoking cessation aid, Reduction of nicotine withdrawal symptoms.

At a glance

Generic name	Nicotine Mini-Lozenge
Sponsor	University of Wisconsin, Madison
Drug class	Nicotine replacement therapy (NRT)
Target	Nicotinic acetylcholine receptors
Modality	Small molecule
Therapeutic area	Smoking Cessation / Addiction Medicine
Phase	FDA-approved

Mechanism of action

Nicotine binds to nicotinic acetylcholine receptors in the central nervous system, mimicking the effects of inhaled nicotine from cigarettes. The mini-lozenge formulation provides rapid nicotine delivery through the oral mucosa, helping to satisfy cravings and ease the transition away from smoking. This allows smokers to gradually reduce nicotine dependence while managing withdrawal symptoms.

Approved indications

Smoking cessation aid
Reduction of nicotine withdrawal symptoms

Common side effects

Mouth irritation
Hiccups
Nausea
Headache
Dizziness

Key clinical trials

iCanQuit Smoking Cessation Among Hispanic Adults (PHASE3)
Varenicline for Smoking Reduction in Veterans Not Ready To Quit (PHASE4)
Mindfulness-based Smoking Cessation Enhanced With Mobile Technology (NA)
Take A Break - Rural (NA)
Health Systems Reach Interventions Project (PHASE4)
The Options 2 Study (PHASE4)
Cessation Screening Project (PHASE4)
Treating Caregivers Who Smoke at AFCH (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Nicotine Mini-Lozenge CI brief — competitive landscape report
Nicotine Mini-Lozenge updates RSS · CI watch RSS
University of Wisconsin, Madison portfolio CI

Frequently asked questions about Nicotine Mini-Lozenge

What is Nicotine Mini-Lozenge?

Nicotine Mini-Lozenge is a Nicotine replacement therapy (NRT) drug developed by University of Wisconsin, Madison, indicated for Smoking cessation aid, Reduction of nicotine withdrawal symptoms.

How does Nicotine Mini-Lozenge work?

Nicotine mini-lozenges deliver nicotine through oral mucosal absorption to reduce cravings and withdrawal symptoms during smoking cessation.

What is Nicotine Mini-Lozenge used for?

Nicotine Mini-Lozenge is indicated for Smoking cessation aid, Reduction of nicotine withdrawal symptoms.

Who makes Nicotine Mini-Lozenge?

Nicotine Mini-Lozenge is developed and marketed by University of Wisconsin, Madison (see full University of Wisconsin, Madison pipeline at /company/university-of-wisconsin-madison).

What drug class is Nicotine Mini-Lozenge in?

Nicotine Mini-Lozenge belongs to the Nicotine replacement therapy (NRT) class. See all Nicotine replacement therapy (NRT) drugs at /class/nicotine-replacement-therapy-nrt.

What development phase is Nicotine Mini-Lozenge in?

Nicotine Mini-Lozenge is FDA-approved (marketed).

What are the side effects of Nicotine Mini-Lozenge?

Common side effects of Nicotine Mini-Lozenge include Mouth irritation, Hiccups, Nausea, Headache, Dizziness.

What does Nicotine Mini-Lozenge target?

Nicotine Mini-Lozenge targets Nicotinic acetylcholine receptors and is a Nicotine replacement therapy (NRT).

Drug class: All Nicotine replacement therapy (NRT) drugs
Target: All drugs targeting Nicotinic acetylcholine receptors
Manufacturer: University of Wisconsin, Madison — full pipeline
Therapeutic area: All drugs in Smoking Cessation / Addiction Medicine
Indication: Drugs for Smoking cessation aid
Indication: Drugs for Reduction of nicotine withdrawal symptoms

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing