Product Description
Donepezil is used to treat dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and may cause changes in mood and personality) in people who have Alzheimer's disease (AD; a brain disease that slowly destroys the memory and the ability to think, learn, communicate and handle daily activities). Donepezil is in a class of medications called cholinesterase inhibitors. It improves mental function (such as memory, attention, the ability to interact with others, speak, think clearly, and perform regular daily activities) by increasing the amount of a certain naturally occurring substance in the brain. Donepezil may improve the ability to think and remember or slow the loss of these abilities in people who have AD. However, donepezil will not cure AD or prevent the loss of mental abilities at some time in the future. (Sourced from: https://medlineplus.gov/druginfo/meds/a697032.html)
Mechanisms of Action: ACHE Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Alzheimer Disease | Dementia | Alzheimer Disease | Dementia
Known Adverse Events: Insomnia | Muscle Cramp | Anorexia | Diarrhea | Dizziness | Headache | Ecchymosis
Company: Eisai
Company Location: BUNKYO-KU TOKOYO 112 M0
Company CEO: Haruo Naito
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, China, Korea, Malaysia, Taiwan, United States
Active Clinical Trial Count: 13
Highest Development Phases
Phase 3: Alzheimer Disease|Cognitive Dysfunction|Down Syndrome
Phase 2: Other|Parkinson's Disease
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2022-001751-17 | P2 |
Active, not recruiting |
Parkinson's Disease |
2026-05-03 |
|
| DON102-CTP | P1 |
Not yet recruiting |
Alzheimer Disease |
2025-03-31 |
43% |
| MK-1167-007 | P1 |
Completed |
Alzheimer Disease |
2024-09-23 |
|
| IVL3003-001 | P2 |
Recruiting |
Alzheimer Disease |
2024-03-31 |