Last reviewed · How we verify
Nicorette (NICOTINE)
Nicorette is a cholinergic nicotinic agonist, a small molecule that targets the neuronal acetylcholine receptor alpha4/beta2. Originally developed by Sanofi Aventis US, it is now owned by Chattem Sanofi. Nicorette is FDA-approved for various indications, including nicotine withdrawal symptoms, nicotine dependence, and smoking cessation assistance. It has been off-patent since its approval in 1991, with a single generic manufacturer. Key safety considerations include its short half-life of 2.0 hours and moderate bioavailability of 30%.
At a glance
| Generic name | NICOTINE |
|---|---|
| Sponsor | Sanofi |
| Drug class | Cholinergic Nicotinic Agonist [EPC] |
| Target | Neuronal acetylcholine receptor; alpha4/beta2 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1991 |
Approved indications
- Niacin deficiency
- Nicotine Withdrawal Symptoms
- Nicotine dependence
- Pellagra
- Smoking cessation assistance
Common side effects
Key clinical trials
- Pharmacokinetic and Subjective Effects of Heated Tobacco Products (NA)
- Using Smartwatches to Monitor Smoking in Real-life Situations
- Characterization of Phenotypic and Genotypic Regressors for Imaging
- Cognitive Task Development and Implementation for Functional MRI Studies
- Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC) (NA)
- The Trans-Led Care Study (NA)
- Orexin s Role in the Neurobiology of Substance Use Disorder (NA)
- Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study (PHASE3)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Nicorette CI brief — competitive landscape report
- Nicorette updates RSS · CI watch RSS
- Sanofi portfolio CI