SB742457 Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple completed clinical trials sponsored by GlaxoSmithKline have evaluated SB742457 for Alzheimer's disease across Phase I and Phase II development. A Phase II trial evaluated the compound in comparison with donepezil and placebo in subjects with mild-to-moderate Alzheimer's disease. Additionally, a Phase I crossover trial assessed the pharmacokinetics of single doses delivered in capsule and tablet formulations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00708552	Completed	Alzheimer''s Disease	GlaxoSmithKline	2008-07-04	Phase 2
NCT00551772	Completed	Alzheimer''s Disease	GlaxoSmithKline	2007-08	Phase 1

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

Check the SB742457 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SB742457 acts as a highly selective 5-HT6 receptor antagonist with a pKi of 9.63, binding to central 5-HT6 receptors to inhibit intracellular downstream signaling and modulate neurotransmitter release. This blockade enhances cholinergic and glutamatergic neurotransmission, providing therapeutic relevance for cognitive enhancement in conditions such as Alzheimer's disease.

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>).