Overview
In 2016, the global burden of dementia was estimated to be 43.8 million, demonstrating a significant increase from a global prevalence of 20.2 million in 1990. Donepezil, also known as Aricept, is a piperidine derivative acetylcholinesterase inhibitor used in the management of the dementia of Alzheimer's Disease, and in some cases, is used to manage other types of dementia. Donepezil was first approved by the FDA in 1996, and its extended-release form was approved in combination with Memantine in 2014 to manage moderate and severe forms of Alzheimer's dementia. A donepezil transdermal delivery system, Adlarity, was approved by the FDA in March 2022 for the treatment of Alzheimer's dementia. Though it does not alter the progression of Alzheimer's disease, donepezil is effective in managing the symptoms of its associated dementia.
Indication
Donepezil, administered orally or via transdermal delivery system, is indicated for the treatment of dementia of the Alzheimer's type. It is also available as an extended-release capsule in combination with memantine for the treatment of moderate-to-severe dementia of the Alzheimer's type in patients previously stabilized on 10mg of donepezil hydrochloride once daily. Off-label uses include the management of vascular dementia, Parkinson's Disease-associated dementia, and Lewy body dementia, amongst others.
Associated Conditions
- Alzheimer's Disease (AD)
- Dementia With Lewy Body Disease
- Dementia due to Parkinson's disease
- Dementia of the Alzheimer's Type
- Vascular Dementia (VaD)
- Moderate Alzheimer's Type Dementia
- Severe Alzheimer's Type Dementia
Research Report
A Comprehensive Monograph on Donepezil (DB00843): Pharmacology, Clinical Efficacy, and Therapeutic Landscape
Section 1: Executive Summary & Introduction
1.1. Overview of Donepezil
Donepezil is a centrally acting, reversible inhibitor of the enzyme acetylcholinesterase (AChE).[1] It represents a second generation of AChE inhibitors, developed for the palliative treatment of dementia associated with Alzheimer's disease following the clinical and safety challenges encountered with first-generation agents like tacrine.[2] Marketed principally under the brand name Aricept®, among others, donepezil has become a cornerstone in the symptomatic management of Alzheimer's disease across its full spectrum, from mild to severe stages.[1] Its development by Eisai, beginning in 1983, culminated in its initial approval by the U.S. Food and Drug Administration (FDA) in 1996, and it has since become one of the most widely prescribed medications for this condition globally.[1]
1.2. Key Therapeutic Attributes
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/15 | Not Applicable | Not yet recruiting | Wanbangde Pharmaceutical Group Co., LTD | ||
2025/04/01 | Phase 2 | Recruiting | |||
2025/02/14 | N/A | Not yet recruiting | |||
2025/01/14 | Phase 1 | Not yet recruiting | |||
2024/11/14 | Phase 2 | Not yet recruiting | Centre Hospitalier St Anne | ||
2024/07/25 | Phase 2 | Not yet recruiting | |||
2024/05/16 | Not Applicable | Recruiting | ZhanYJ | ||
2024/05/01 | Early Phase 1 | Completed | |||
2024/04/18 | Phase 1 | Not yet recruiting | Shanghai Synergy Pharmaceutical Sciences Co., Ltd. | ||
2024/02/29 | Phase 1 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Vensun Pharmaceuticals, Inc. | 42543-702 | ORAL | 5 mg in 1 1 | 1/18/2018 | |
| NuCare Pharmaceuticals, Inc. | 68071-3198 | ORAL | 10 mg in 1 1 | 1/14/2022 | |
| Bryant Ranch Prepack | 72162-2137 | ORAL | 10 mg in 1 1 | 4/4/2024 | |
| Solco Healthcare US, LLC | 43547-276 | ORAL | 10 mg in 1 1 | 6/30/2025 | |
| Allergan, Inc. | 0456-1228 | ORAL | 10 mg in 1 1 | 11/9/2023 | |
| Bryant Ranch Prepack | 63629-8483 | ORAL | 23 mg in 1 1 | 1/19/2022 | |
| Torrent Pharmaceuticals Limited | 13668-103 | ORAL | 10 mg in 1 1 | 7/25/2022 | |
| NuCare Pharmaceuticals, Inc. | 68071-3396 | ORAL | 5 mg in 1 1 | 2/12/2021 | |
| Jubilant Cadista Pharmaceuticals Inc. | 59746-329 | ORAL | 5 mg in 1 1 | 1/26/2019 | |
| Hisun Pharmaceuticals USA, Inc. | 42658-119 | ORAL | 5 mg in 1 1 | 2/14/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TORPEZIL TABLETS 5 MG | SIN15250P | TABLET, FILM COATED | 5 mg | 5/31/2017 | |
| ALZER 10 DONEPEZIL HYDROCHLORIDE TABLETS USP 10 MG | SIN16006P | TABLET, FILM COATED | 10.00 mg | 9/7/2020 | |
| ARIPEZIL FILM-COATED TABLET 10MG | SIN15516P | TABLET, FILM COATED | 10mg | 7/26/2018 | |
| DOPEZIL TABLETS 5MG | SIN14390P | TABLET, FILM COATED | 5.00mg | 7/31/2013 | |
| DONCEPT F.C. TABLET 5MG | SIN15086P | TABLET, FILM COATED | 5mg | 9/13/2016 | |
| ARIPEZIL FILM-COATED TABLET 5MG | SIN15517P | TABLET, FILM COATED | 5mg | 7/26/2018 | |
| Aricept Evess 10mg orodispersible tablet | SIN13646P | TABLET, ORALLY DISINTEGRATING | 10mg | 5/4/2009 | |
| JUBDOZIL FILM COATED TABLET 5MG | SIN15565P | TABLET, FILM COATED | 5mg | 10/22/2018 | |
| DONEPEZIL MEVON FILM-COATED TABLETS 10 MG | SIN14811P | TABLET, FILM COATED | 10 mg | 7/15/2015 | |
| DOPEZIL TABLETS 10MG | SIN14389P | TABLET, FILM COATED | 10.00mg | 7/31/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ARICEPT TAB 5MG | N/A | N/A | N/A | 3/12/1998 | |
| ARICEPT TABLETS 23MG | N/A | N/A | N/A | 4/17/2013 | |
| DONEPEZIL HYDROCHLORIDE TAB 10MG | N/A | N/A | N/A | 12/18/2012 | |
| ARICEPT TAB 10MG | N/A | N/A | N/A | 3/12/1998 | |
| DONEPEZIL HYDROCHLORIDE TABLETS 5MG | N/A | N/A | N/A | 12/18/2012 | |
| ARICEPT EVESS ORODISPERSIBLE TAB 10MG | N/A | N/A | N/A | 11/16/2009 | |
| ARICEPT EVESS ORODISPERSIBLE TAB 5MG | N/A | N/A | N/A | 11/16/2009 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| AG-DONEPEZIL | angita pharma inc. | 02432692 | Tablet - Oral | 10 MG | 5/10/2021 |
| JAMP-DONEPEZIL | 02404427 | Tablet - Oral | 10 MG | 12/27/2013 | |
| TEVA-DONEPEZIL | teva canada limited | 02340615 | Tablet - Oral | 10 MG | 12/27/2013 |
| SEPTA DONEPEZIL | septa pharmaceuticals inc | 02428482 | Tablet - Oral | 5 MG | 10/30/2014 |
| SANDOZ DONEPEZIL | 02328666 | Tablet - Oral | 5 MG | 12/27/2013 | |
| NAT-DONEPEZIL | natco pharma (canada) inc | 02439557 | Tablet - Oral | 5 MG | 7/22/2015 |
| SANDOZ DONEPEZIL ODT | 02367688 | Tablet (Orally Disintegrating) - Oral | 5 MG | 3/19/2014 | |
| ARICEPT | 02232043 | Tablet - Oral | 5 MG | 8/20/1997 | |
| MINT-DONEPEZIL | mint pharmaceuticals inc | 02408600 | Tablet - Oral | 5 MG | 6/11/2019 |
| ACH-DONEPEZIL | 02402645 | Tablet - Oral | 5 MG | 12/27/2013 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ARICEPT 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 61869 | COMPRIMIDO RECUBIERTO | Diagnóstico Hospitalario | Commercialized | |
| ARICEPT 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 61870 | COMPRIMIDO RECUBIERTO | Diagnóstico Hospitalario | Commercialized | |
| ARICEPT 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | Pfizer Hellas S.A. | 75519-20-11-2007IP1 | COMPRIMIDO RECUBIERTO | Diagnóstico Hospitalario | Commercialized |
| ARICEPT 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | Pfizer Hellas S.A. | 75519-20-11-2007 | COMPRIMIDO RECUBIERTO | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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