How many clinical trials are studying Donepezil?

5 recruiting trials in our tracked data involve Donepezil.

What conditions is Donepezil being studied for?

In our tracked recruiting trials, Donepezil is being studied in trials for Alzheimer's disease, Alzheimer Disease, Cognitive Impairment.

Donepezil: clinical trials recruiting now

Q: Is Donepezil FDA-approved?

Yes. According to the FDA drug label available through openFDA, Donepezil is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Donepezil appears in the FDA drug-label database. Marketed as DONEPEZIL HYDROCHLORIDE.

FDA-approved use

Donepezil hydrochloride tablet is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease ( 1 ). Donepezil hydrochloride tablet is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.

FDA recalls / enforcement

Reason (FDA)	Classification	Status	Initiated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. — CARDINAL HEALTHCARE	Class II (FDA: may cause temporary or reversible harm)	Terminated	2022-01-26
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. — CARDINAL HEALTHCARE	Class II (FDA: may cause temporary or reversible harm)	Terminated	2022-01-26
CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc.	Class II (FDA: may cause temporary or reversible harm)	Terminated	2021-03-15

FDA label via openFDA

Phase breakdown

Phase 2 1 Phase 3 1 Not applicable 3

Conditions being studied

Condition	Trials
Alzheimer's disease · Donepezil for Alzheimer's disease	5
Alzheimer Disease	2
Cognitive Impairment	2
Alzheimer Disease, Early Onset	1
Alzheimer's Disease (AD)	1
Cognitive Decline	1
Dementia	1
Mild Cognitivie Impairment (MCI)	1
Osteoporosis	1

Recruiting trials involving Donepezil

Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers
NCT06417086 · Phase: Not applicable (e.g. observational or device study) · Ages: 50 Years to 80 Years · Sex: All (male and female) · 1 location
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease
NCT03810794 · Phase: Not applicable (e.g. observational or device study) · Ages: 50 Years to 85 Years · Sex: All (male and female) · 3 locations
Donepezil Versus Non-drug Treatment in Alzheimer's Disease.
NCT04661280 · Phase: Phase 3 · Ages: 50 Years and older · Sex: All (male and female) · 1 location
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
NCT06041789 · Phase: Phase 2 · Ages: 50 Years and older · Sex: All (male and female) · 2 locations
δ in Dementia Clinical Trials
NCT05592678 · Phase: Not applicable (e.g. observational or device study) · Ages: 65 Years to 100 Years · Sex: All (male and female) · 1 location

Common questions

Is Donepezil FDA-approved?

Yes, marketed as DONEPEZIL HYDROCHLORIDE.

How many recruiting trials involve Donepezil?

5 recruiting trials across 9 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.