Galanthamine Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

A clinical trial evaluated the therapeutic role and safety profile of galanthamine in neurodegenerative conditions, specifically Alzheimer's disease and dementia. Sponsored by Janssen-Cilag Pty Ltd, this completed observational study lacked a formally specified phase designation while assessing long-term clinical outcomes and real-world treatment management over an 18-month duration. Overall, these findings highlight galanthamine's clinical utility for managing cognitive decline in central nervous system disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00299676	Completed	Alzheimer Disease\|Dementia\|Galantamine	Janssen-Cilag Pty Ltd	2005-05	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Galanthamine acts as a reversible, competitive inhibitor of acetylcholinesterase with an IC50 of 0.35 μM, which blocks the enzymatic breakdown of acetylcholine within synaptic clefts. By preserving acetylcholine levels and enhancing central cholinergic neurotransmission, galanthamine mitigates cognitive decline in neurodegenerative conditions such as Alzheimer's disease and dementia.

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>).