Last reviewed · How we verify
Nicotine (4 mg)
Nicotine (4 mg) is a Nicotinic acetylcholine receptor agonist Small molecule drug developed by GlaxoSmithKline. It is currently FDA-approved for Smoking cessation aid.
Nicotine binds to nicotinic acetylcholine receptors in the brain and peripheral nervous system, providing nicotine replacement to reduce cravings and withdrawal symptoms during smoking cessation.
Nicotine (4 mg) is a small molecule used in various interventions for conditions such as smoking cessation, ADHD, and tobacco use disorder, including self-help materials, nicotine patches, and smartphone-delivered automated treatment. It has been studied in clinical trials for its potential to aid in smoking cessation and management of other conditions.
At a glance
| Generic name | Nicotine (4 mg) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Nicotinic acetylcholine receptor agonist |
| Target | Nicotinic acetylcholine receptors |
| Modality | Small molecule |
| Therapeutic area | Smoking Cessation / Addiction Medicine |
| Phase | FDA-approved |
Mechanism of action
Nicotine is an alkaloid that acts as an agonist at nicotinic acetylcholine receptors, mimicking the effects of acetylcholine. By delivering controlled doses of nicotine without the harmful combustion products of tobacco, it reduces the withdrawal symptoms and cravings associated with smoking cessation, allowing patients to gradually reduce their dependence on nicotine.
Approved indications
- Smoking cessation aid
Common side effects
- Mouth irritation
- Hiccups
- Dyspepsia
- Nausea
- Jaw soreness
Key clinical trials
- Pharmacokinetic and Subjective Effects of Heated Tobacco Products (NA)
- Orexin s Role in the Neurobiology of Substance Use Disorder (NA)
- Nordic Spirit Pouch Nicotine Pharmacokinetics Abuse Liability (PHASE1)
- Varenicline for Smoking Reduction in Veterans Not Ready To Quit (PHASE4)
- Mindfulness And Placebo for Pain (MAPP) Study (NA)
- Rural Smoking Cessation (NA)
- A Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products (NA)
- ACT_for Alcohol Use Disorder and Depression (NA)
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 (4 mg) CI brief — competitive landscape report
- Nicotine (4 mg) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Nicotine (4 mg)
What is Nicotine (4 mg)?
How does Nicotine (4 mg) work?
What is Nicotine (4 mg) used for?
Who makes Nicotine (4 mg)?
What drug class is Nicotine (4 mg) in?
What development phase is Nicotine (4 mg) in?
What are the side effects of Nicotine (4 mg)?
What does Nicotine (4 mg) target?
Related
- Drug class: All Nicotinic acetylcholine receptor agonist drugs
- Target: All drugs targeting Nicotinic acetylcholine receptors
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Smoking Cessation / Addiction Medicine
- Indication: Drugs for Smoking cessation aid
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing