WAY-100635 Maleate Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

A completed Phase 1 clinical trial sponsored by GlaxoSmithKline evaluated brain 5-HT1A receptor occupancy and pharmacokinetics using positron emission tomography in healthy male participants. This industry-sponsored study assessed target engagement relevant to depressive disorder and anxiety disorders. Overall, recorded clinical research for WAY-100635 remains limited to a clinical trial evaluating pharmacological mechanisms in the human brain.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00435695	COMPLETED	Healthy Subjects; Depressive Disorder and Anxiety Disorders	GlaxoSmithKline	2006-11	PHASE1

(data from https://clinicaltrials.gov, updated on 2012-06-04)

Check the WAY-100635 Maleate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

WAY-100635 acts as a highly potent and selective antagonist of the 5-hydroxytryptamine 1A (5-HT1A) receptor, selectively binding to 5-HT1A autoreceptors to inhibit serotonin-mediated autoinhibition and increase neuronal firing activity. This reversal of autoreceptor-mediated feedback elevates serotonergic neurotransmission, establishing the mechanistic rationale for evaluating receptor occupancy in healthy individuals and patients with depressive disorder and anxiety disorders.

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>).