Last reviewed · How we verify
Aricept (DONEPEZIL)
Aricept works by blocking the enzyme that breaks down a key neurotransmitter in the brain, acetylcholine.
Aricept (donepezil) is a small molecule cholinesterase inhibitor developed by Eisai Inc, targeting the Sigma non-opioid intracellular receptor 1. It is FDA-approved since 1996 for the treatment of Alzheimer's disease and moderate to severe Alzheimer's type dementia. As a cholinesterase inhibitor, Aricept is commercially available in both patented and generic forms, with 39 generic manufacturers. The drug has a long half-life of 70 hours and high bioavailability of 99%. Key safety considerations include monitoring for gastrointestinal side effects and potential interactions with other medications.
At a glance
| Generic name | DONEPEZIL |
|---|---|
| Sponsor | Eisai |
| Drug class | Cholinesterase Inhibitor |
| Target | Sigma non-opioid intracellular receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1996 |
| Annual revenue | 800 |
Mechanism of action
. Mechanism of Action. Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimers disease attribute some of them to deficiency of cholinergic neurotransmission.Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase. There is no evidence that donepezil alters the course of the underlying dementing process.
Approved indications
- Alzheimer's disease
- Moderate to Severe Alzheimer's Type Dementia
Common side effects
- Accident
- Anorexia
- Back Pain
- Chest Pain
- Confusion
- Diarrhea
- Dizziness
- Emotional Lability
- Fatigue
- Fever
- Hallucinations
- Headache
Key clinical trials
- Investigating the Cholinergic Contribution to Gait Dysfunction in Parkinson's Disease (PHASE2)
- Donepezil Versus Non-drug Treatment in Alzheimer's Disease. (PHASE3)
- Ultrasound-Guided Stellate Ganglion Block for Alzheimer's Disease (NA)
- Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease (NA)
- Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007) (PHASE1)
- Intravenous Infusion of Umbilical Cord Blood as an Adjunctive Treatment for Alzheimer's Disease (EARLY_PHASE1)
- Masitinib in Patients With Mild Alzheimer's Disease (PHASE3)
- Effect of Donepezil on Speech Recognition in Cochlear Implant Users (EARLY_PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |