NDAORALTABLETPriority Review
Approved
Nov 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARICEPT (donepezil hydrochloride) is an oral small-molecule acetylcholinesterase inhibitor approved in 1996 for Alzheimer's disease and cognitive dysfunction. It enhances cholinergic neurotransmission by reversibly inhibiting acetylcholine hydrolysis, though it does not alter the underlying disease course. The drug is available in tablet and orally disintegrating tablet formulations at 5 mg, 10 mg, and 23 mg doses.
$2MPart D
LOE ApproachingDeclining
As patent exclusivity expires, teams face consolidation pressures and shift focus toward lifecycle management and cost optimization rather than market expansion.
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 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 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 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.