GSK805 Clinical Trials

Size	Price	Qty
5mg	USD 167
25mg	USD 567

Clinical Trials

The clinical evaluation of GSK805 (also known as GSK2336805) includes a clinical trial sponsored by the pharmaceutical company GlaxoSmithKline. This completed early-stage Phase 1 study evaluated the pharmacokinetics, safety, and tolerability of the compound in Hepatitis C patients exhibiting varying degrees of hepatic impairment. Consequently, documented clinical research on GSK805 is focused on initial safety assessment and drug disposition in individuals affected by chronic liver disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01827657	Completed	Hepatitis C	GlaxoSmithKline	2013-05-28	Phase 1

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

Check the GSK805 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK805 acts as a potent inhibitor of retinoic acid receptor-related orphan receptor gamma t (RORγt), blocking its transcriptional activity and suppressing the downstream production of pro-inflammatory cytokines such as interleukin-17. By attenuating Th17-mediated inflammatory cascades and tissue pathology, this selective inhibition provides therapeutic potential in mitigating hepatic inflammation associated with clinical conditions like Hepatitis C.

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>).