NDANASALSPRAY, METERED
Approved
Mar 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
NICOTROL (nicotine) by Pfizer. Approved for cholinergic nicotinic agonist [epc]. First approved in 1996.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NICOTROL is a nicotine nasal spray approved for smoking cessation, delivering nicotine directly through the nasal mucosa as a cholinergic nicotinic agonist. It works by stimulating nicotinic acetylcholine receptors to reduce cravings and withdrawal symptoms in patients attempting to quit smoking. The metered-dose formulation provides rapid nicotine delivery comparable to smoking.
LOE Approaching
Product is in late lifecycle with approaching loss of exclusivity, signaling potential team reductions or transition focus toward generic transition planning.
Mechanism of Action
Pharmacologic Class:
Cholinergic Nicotinic Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes
Started May 2026
800 enrolled
Vaping Cessation
Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation
Started Apr 2025
150 enrolled
Tobacco
Pilot Study of the YES-CAN! Program to Prevent Youth Nicotine Vaping
Started Aug 2024
1,166 enrolled
Nicotine Vaping
Nicotine Influence on the Retina Following the Use of Electronic Cigarette
Started Aug 2022
44 enrolled
Electronic Cigarette UseRetina; Change
Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy
Started Jan 2022
1,307 enrolled
Nicotine Addiction
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.