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.
Background
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
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 | |||
2023/09/18 | Phase 2 | 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 | 8/30/2023 | |
| 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 |
|---|---|---|---|---|---|
| Donepezil Hydrochloride Pills | 国药准字H20051954 | 化学药品 | 滴丸剂 | 12/23/2019 | |
| Donepezil Hydrochloride Orally Disintegrating Tablets | 国药准字H20140071 | 化学药品 | 片剂 | 3/5/2024 | |
| Donepezil Hydrochloride Orally Disintegrating Tablets | 国药准字H20243640 | 化学药品 | 片剂 | 4/30/2024 | |
| Donepezil Hydrochloride Orally Disintegrating Tablets | 国药准字H20243527 | 化学药品 | 口崩片 | 4/17/2024 | |
| Donepezil Hydrochloride Orally Disintegrating Tablets | 国药准字H20203232 | 化学药品 | 片剂 | 6/2/2020 | |
| Donepezil Hydrochloride Orally Disintegrating Tablets | 国药准字H20243639 | 化学药品 | 片剂 | 4/30/2024 | |
| Donepezil Hydrochloride Orally Disintegrating Tablets | 国药准字H20150057 | 化学药品 | 片剂 | 6/17/2020 | |
| Donepezil Hydrochloride Orally Disintegrating Tablets | 国药准字H20110091 | 化学药品 | 片剂 | 5/11/2021 | |
| Donepezil Hydrochloride Orally Disintegrating Tablets | 国药准字H20203231 | 化学药品 | 片剂 | 6/2/2020 | |
| Donepezil Hydrochloride Orally Disintegrating Tablets | 国药准字H20130091 | 化学药品 | 片剂 | 2/1/2023 |
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 |