Homotaurine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Homotaurine has been evaluated in several clinical trials targeting neurodegenerative and ocular conditions, specifically Alzheimer's disease and glaucoma. These investigations span multiple phases—ranging from Phase I safety and pharmacokinetic studies to Phase III open-label extensions and non-phased evaluations—sponsored by academic institutions such as IRCCS Policlinico S. Matteo alongside commercial entities including Alzheon Inc. and Bellus Health Inc. Recorded trial statuses vary across the registry, encompassing completed, terminated, and unknown recruitment states.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04422743	Terminated	Glaucoma	IRCCS Policlinico S. Matteo	2018-01-25	Not Applicable
NCT04157712	Completed	Alzheimer Disease	Alzheon Inc.\|Quotient Clinical	2015-09-26	Phase 1
NCT00314912	Unknown status	Alzheimer''s Disease	Bellus Health Inc. - a GSK company	2006-05	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Homotaurine functions as a low-efficacy partial agonist at GABAA and GABAB receptors, mimicking endogenous gamma-aminobutyric acid to modulate inhibitory signaling and reduce neuronal hyperexcitability. By regulating GABAergic neurotransmission and preventing neurotoxic signaling cascades, Homotaurine exerts neuroprotective effects relevant to the therapeutic management of neurodegenerative disorders such as Alzheimer's disease and glaucoma.

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>).