NDAORALTABLET
Approved
Jul 2010
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed 15h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARICEPT (donepezil hydrochloride) is an oral small-molecule acetylcholinesterase inhibitor approved for Alzheimer's disease. It works by increasing acetylcholine levels in the brain to improve cognitive function and memory. The drug is administered as a tablet and targets patients with mild to moderate Alzheimer's disease.
LOE Approaching2mo to LOE
Product is approaching loss of exclusivity with only 0.3 years of patent protection remaining, indicating a contracting brand team focused on transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies (DLB).
Started Apr 2015
591 enrolled
Dementia With Lewy Body Disease
A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
Started Mar 2015
2,231 enrolled
Alzheimer's Disease
A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
Started Mar 2015
160 enrolled
Dementia, Lewy BodyLewy Body Disease
A Multi-national Study to Identify Treatment Discontinuation Rate in de Novo Alzheimer's Disease Patients Who Have Been Newly Prescribed With Donepezil (Aricept) in Asia (ADOS)
Started Jul 2014
532 enrolled
Alzheimer's Disease
A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease
Started Aug 2013
302 enrolled
Dementia Associated With Cerebrovascular Disease
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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.