Aricept

(donepezil hydrochloride)

ApprovedSmall molecule

Aricept is a small molecule that works as Acetylcholinesterase Inhibitor.[2] It is being used across 3 indications, with its most advanced program in Approved.[1]

Aricept is one of 31 small molecule programs targeting Lewy body dementia. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Lewy Body DementiaActive, not recruiting

Alzheimer Disease Type 1Active, not recruiting

Vascular DiseaseCompleted

Lewy Body DementiaPreclinical

Active, not recruiting

Alzheimer Disease Type 1Preclinical

Active, not recruiting

Vascular DiseaseApproved

Completed

Competition

Competitive Landscape

27 competitors in Vascular Disease

#DrugCompanyPhaseTrials

Crestor

AstraZeneca

Approved

2 2

Repatha

Amgen

Approved

1 3

Precose

Bayer

Approved

1 4

Letairis

Colcrys

Xarelto

1 7

Bystolic

VVitae Pharmaceuticals Inc., an Allergan affiliate

Approved

1 8

Andriol

AAuxilium

Approved

1 9

Neo-Synephrine

EExela Pharma Sciences, LLC.

Approved

—10

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Not yet recruiting

Alzheimer's Disease

NCT06828289

Q3 2028

PreclinicalRecruiting

Alzheimer Dementia

NCT07066826

Clinical

Trials by Indication[1]

Alzheimer's Disease10 trials

Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

Completed· Eisai logo

Eisai··NCT01129596·10,238 enrolled

Post-marketing Surveillance of Donepezil Hydrochloride Investigation of the Safety and Effectiveness of Combination Therapy of Donepezil Hydrochloride and Memantine Hydrochloride in Patients With Alzheimer's Disease

Completed· Eisai logo

Eisai··NCT02162251·3,482 enrolled

Neural Correlates In Mild Alzheimer's Disease

Completed· Eisai logo

Eisai·Phase 4·NCT00477659·14 enrolled

Show 7 more trials

Progress of Mild Alzheimer's Disease in Participants on Acupuncture Versus Sham Acupuncture

Completed·—·N/A·NCT05078944·160 enrolled

Rivastigmine Mini-Tablet for Alzheimer's Disease

Not yet recruiting·PPeking University First Hospital··NCT06828289·1,000 enrolled

Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease

Completed· Eisai logo

Eisai··NCT01251718·894 enrolled

Alzheimer's Disease Long-term Follow-up Study (ALF Study)

Completed· Eisai logo

Eisai·Phase 4·NCT00165724·114 enrolled

Evaluating The Impact Of Donepezil Hydrochloride (Aricept) On Behavioral And Psychological Symptoms In Patients With Severe Alzheimer's Disease

Withdrawn· Eisai logo

Eisai·Phase 4·NCT00711204

Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease

Completed· Eisai logo

Eisai·Phase 3·NCT00096473·229 enrolled

Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Factors That Affect Aricept Medication Persistence Rate and the Safety and Efficacy in Patients With Alzheimer's Disease in Clinical Practice

Completed· Eisai logo

Eisai··NCT02162264·8,662 enrolled

Cognitive impairment3 trials

Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease

Unknown status·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 2·NCT05709301·120 enrolled

The Effect of Donepezil in Radiotherapy-related Cognitive Impairment.

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT03907371·238 enrolled

The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)

Completed· Eisai logo

Eisai·Phase 4·NCT00293176·821 enrolled

Fasting Conditions2 trials

10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT01260948·26 enrolled

10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.

Completed· Teva logo

Teva·Phase 1·NCT01260922·26 enrolled

Adult2 trials

A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males

Completed· Eisai logo

Eisai·Phase 1·NCT01506739·12 enrolled

A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males

Completed· Eisai logo

Eisai·Phase 1·NCT01506752·20 enrolled

Vascular Disease2 trials

Donepezil Hydrochloride (E2020) in Dementia Associated With Cerebrovascular Disease

Completed· Eisai logo

Eisai·Phase 3·NCT00165737·974 enrolled

A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease

Completed· Eisai logo

Eisai·Phase 4·NCT02660983·302 enrolled

21 more indications

Dementia2 trials

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).

Completed· Eisai logo

Eisai··NCT02448784·591 enrolled

A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)

Completed· Eisai logo

Eisai·Phase 2·NCT00543855·167 enrolled

Fed1 trial

Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition

Completed·—·Phase 1·NCT01504516·25 enrolled

Small Cell Lung Cancer1 trial

Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00006349·9 enrolled

Treatment1 trial

Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

Terminated· Eisai logo

Eisai·Phase 4·NCT00165750·40 enrolled

Alzheimer disease1 trial

A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease

Unknown status·ZZhejiang Provincial People's Hospital·Phase 4·NCT03151382·30 enrolled

Clinical Trial1 trial

Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults

Completed·DDong-A ST Co., Ltd.·Phase 1·NCT04013477·40 enrolled

Autism1 trial

The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism

Completed·NNational Institute of Mental Health (NIMH)·Phase 1/2·NCT00695136·17 enrolled

PK/PD1 trial

Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects

Completed· Teva logo

Teva·Phase 1·NCT01903824·40 enrolled

Stellate Ganglion Block1 trial

Ultrasound-Guided Stellate Ganglion Block for Alzheimer's Disease

Completed·—·N/A·NCT07351773·40 enrolled

Brain Tumor1 trial

Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor

Completed·WWake Forest University Health Sciences·Phase 2·NCT00070161·68 enrolled

Double-blind1 trial

A Multi-Center, Randomized, Double-Blind, Parallel Group Study With 3 Groups Receiving Placebo, 5 mg of E2020 and 10 mg of E2020

Completed· Eisai logo

Eisai·Phase 2·NCT00165659

Breast Cancer1 trial

Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction

Completed·WWake Forest University Health Sciences·Phase 2·NCT01466270·62 enrolled

Attention1 trial

Detecting an Early Response to Donepezil With Measures of Visual Attention

Completed·NNYU Langone Health·Phase 4·NCT03073876·25 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment

Completed· Eisai logo

Eisai·Phase 3·NCT00688376·72 enrolled

Rett syndrome1 trial

Independent Studies of Dextromethorphan and of Donepezil Hydrochloride for Rett Syndrome

Unknown status·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00069550·90 enrolled

Radiation Therapy1 trial

Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors

Completed·WWake Forest University Health Sciences·Phase 3·NCT00369785·198 enrolled

TIA1 trial

To Explore the Therapeutic Potential of Jiedu Yizhi Formula for Alzheimer 's Disease

Completed·—·Phase 1·NCT06393413·62 enrolled

Vascular Dementia1 trial

Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia

Completed· Eisai logo

Eisai·Phase 4·NCT00165763·36 enrolled

Down syndrome1 trial

Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial

Terminated· Eisai logo

Eisai·Phase 2·NCT00675025·117 enrolled

Alzheimer Dementia1 trial

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel-Group Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

Recruiting·WWanbangde Pharmaceutical Group Co., LTD·Preclinical·NCT07066826·720 enrolled

Unspecified2 trials

Bioequivalence Study for Donepezil Hydrochloride 10 mg Tablets Under Fasting Condition

Completed·—·Phase 1·NCT01504503·26 enrolled

Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects

Completed·SShanghai Synergy Pharmaceutical Sciences Co., Ltd.·Phase 1·NCT03932916·38 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 25, 1996

ARICEPT

NDA NDA020690

Oct 18, 2004

ARICEPT

NDA NDA021719

Oct 18, 2004

ARICEPT ODT

NDA NDA021720

Jul 23, 2010

ARICEPT

NDA NDA022568

Mar 11, 2022

ADLARITY

NDA NDA212304

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for donepezil hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — donepezil hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for donepezil hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA212304). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Eisai company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Acetylcholinesterase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Eisai

Aricept

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2028

Trials by Indication[1]

Alzheimer's Disease10 trials

Cognitive impairment3 trials

Fasting Conditions2 trials

Adult2 trials

Vascular Disease2 trials

Dementia2 trials

Fed1 trial

Small Cell Lung Cancer1 trial

Treatment1 trial

Alzheimer disease1 trial

Clinical Trial1 trial

Autism1 trial

PK/PD1 trial

Stellate Ganglion Block1 trial

Brain Tumor1 trial

Double-blind1 trial

Breast Cancer1 trial

Attention1 trial

Efficacy and Safety1 trial

Rett syndrome1 trial

Radiation Therapy1 trial

TIA1 trial

Vascular Dementia1 trial

Down syndrome1 trial

Alzheimer Dementia1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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