NDAORALTABLETPriority Review
Approved
Nov 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
ARICEPT (donepezil hydrochloride) by Eisai is alzheimer’s disease attribute some of them to a deficiency of cholinergic neurotransmission. Approved for dementia of the alzheimer’s type. First approved in 1996.
Drug data last refreshed 2h ago · AI intelligence enriched 1w 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. It slows cognitive decline by increasing acetylcholine levels in the brain, targeting patients with mild to moderate disease stages. The drug remains a foundational therapy in dementia care despite newer competitive agents.
$0.002BPart D
LOE ApproachingDeclining
Mature product with declining Part D claims signals a shrinking brand team and shift toward generic management or life-cycle extension strategies.
Mechanism of Action
Alzheimer’s disease attribute some of them to a deficiency of cholinergic neurotransmission. Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition…
Indications (1)
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.