ARICEPT (donepezil hydrochloride)
ARICEPT is indicated for the treatment of Alzheimer's Disease; Dementia.
How ARICEPT Works
Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function in the central nervous system. It achieves this by increasing the concentration of acetylcholine through the reversible inhibition of its hydrolysis by the enzyme acetylcholinesterase. By preventing the breakdown of this neurotransmitter, the drug compensates for the cholinergic deficiency attributed to the pathogenesis of Alzheimer’s disease.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1996-11-25
- Patent Cliff
- 2026
- Routes
- ORAL
- Dosage Forms
- SOLUTION, TABLET
ARICEPT Approval History
What ARICEPT Treats
2 indicationsARICEPT is approved for 2 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alzheimer's Disease
- Dementia
ARICEPT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ARICEPT
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04617782 results posted | CL-P-20003 | Ph 1 | completed | Pharmacokinetic Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers |
| NCT00688376 results posted | E2020-G000-333 E2020-G000-334, 2007-005435-28 | Ph 3 | completed | Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment |
| NCT01466270 results posted | IRB00019792-1 U10CA081851, REBACCCWFU 97211 | Ph 2 | completed | Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction |
| NCT00369785 results posted | IRB00000551 U10CA081851, REBACCCWFU 91105 | Ph 3 | completed | Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors |
| NCT04013477 | DA5207_ADK_Ia | Ph 1 | completed | Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults |
| NCT02660983 results posted | E2020-K082-418 | Ph 4 | completed | A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease |
| NCT03259958 | P-16010 | Ph 1 | completed | A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept® |
| NCT02968719 | P-15086 | Ph 1 | completed | A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept® |
| NCT01903824 | C26401/1111 2013-001883-51 | Ph 1 | completed | Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects |
| NCT00695136 results posted | 080154 08-M-0154 | Ph 1, Ph 2 | completed | The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism |
| NCT01506752 | E2020-J081-034 | Ph 1 | completed | A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males |
| NCT01506739 | E2020-J081-033 | Ph 1 | completed | A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males |
| NCT01504503 | 645/09 | Ph 1 | completed | Bioequivalence Study for Donepezil Hydrochloride 10 mg Tablets Under Fasting Condition |
| NCT01504516 | 646-09 | Ph 1 | completed | Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition |
| NCT01245530 | INM-176 | Ph 3 | completed | An Efficacy and Safety Study of INM-176 for the Treatment of Patients With Alzheimer Type Dementia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARICEPT FDA Label Details
Indications & Usage
FDA Label (PDF)ARICEPT is indicated for the treatment of Alzheimer's Disease; Dementia.
ARICEPT Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for ARICEPT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 1 active patents
Trial Analysis
- • 6 total trials
- • Stage: Declining
Competitive Landscape
- • 10 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment