Clinical Trials

Multiple clinical trials evaluating Donepezil HCl focus on Phase 1 development to assess safety, tolerability, and pharmacokinetic profiles in healthy subjects and patients with Alzheimer's disease. Major industry sponsors include Merck Sharp & Dohme LLC, Boehringer Ingelheim, Corium Inc., and Shanghai Synergy Pharmaceutical Sciences Co. Ltd. in collaboration with Zhejiang Huahai Pharmaceutical Co. Ltd. While several clinical trials have reached completed status, others are currently designated as not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06373094 Not yet recruiting
Alzheimer Disease
Shanghai Synergy Pharmaceutical Sciences Co. Ltd.|Zhejiang Huahai Pharmaceutical Co. Ltd.
 2024-06-01 Phase 1
NCT04308304 Completed
Alzheimer''s Disease
Merck Sharp & Dohme LLC
 2021-02-16 Phase 1
NCT04617782 Completed
Healthy Subjects
Corium Inc.
 2020-12-08 Phase 1
NCT03905096 Completed
Healthy
Boehringer Ingelheim
 2019-04-12 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Donepezil HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Donepezil HCl functions as a potent and reversible inhibitor of acetylcholinesterase, thereby blocking the enzymatic degradation of acetylcholine within synaptic clefts and enhancing central cholinergic neurotransmission. This sustained elevation of synaptic acetylcholine restores neuronal signaling to improve cognitive performance, directly counteracting the cholinergic deficits characteristic of Alzheimer's disease evaluated in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.