SB705498 Clinical Trials

Clinical Trials

GlaxoSmithKline has sponsored multiple Phase II clinical trials evaluating the TRPV1 antagonist SB705498 for respiratory and gastrointestinal conditions, specifically rhinitis and irritable colon. Several clinical trials investigating rhinitis reached completed status, evaluating parameters such as pharmacokinetics, pharmacodynamics, and response to capsaicin challenge. Conversely, a clinical trial assessing the compound for irritable colon was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01476098	Completed	Rhinitis	GlaxoSmithKline	2011-04	Phase 2
NCT01424397	Completed	Rhinitis	GlaxoSmithKline	2011-04-14	Phase 2
NCT01424514	Completed	Rhinitis	GlaxoSmithKline	2010-12-01	Phase 2
NCT01439308	Completed	Rhinitis	GlaxoSmithKline	2009-12	Phase 2
NCT00461682	Terminated	Irritable Colon	GlaxoSmithKline	2007-01-26	Phase 2

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

Check the SB705498 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SB705498 acts as a potent and selective antagonist of the transient receptor potential vanilloid 1 (TRPV1) channel, blocking capsaicin-, acid-, and heat-induced activation to prevent intracellular calcium influx in sensory neurons. By suppressing TRPV1-mediated neurogenic inflammation and sensory hypersensitivity, SB705498 demonstrates therapeutic relevance for conditions studied in clinical trials, including rhinitis and irritable colon.

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>).