NDANASALSPRAY, METERED
Approved
Mar 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Drug data last refreshed 9h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NICOTROL is a metered nasal spray formulation of nicotine, a cholinergic nicotinic agonist approved in 1996 for tobacco dependence and smoking cessation. It works by binding stereoselectively to nicotinic-cholinergic receptors in the brain, producing stimulant effects at low doses and reward effects at high doses through dopaminergic and neurohormonal pathways. The nasal spray delivery provides rapid nicotine absorption to support quit attempts.
LOE Approaching
Product is in LOE-approaching phase with $15M annual spending; expect transition planning and maintenance-mode team focus rather than growth initiatives.
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.