GSK3117391 Clinical Trials

Size	Price	Qty
5mg	USD 337

Clinical Trials

A Phase 2 clinical trial sponsored by the pharmaceutical company GlaxoSmithKline evaluated the therapeutic application of GSK3117391 for the treatment of rheumatoid arthritis. This randomized, double-blind, placebo-controlled study was designed to assess the compound's efficacy, safety, tolerability, and pharmacokinetics in affected patients. However, recruitment for the trial was terminated early, leaving clinical evaluation of the drug in autoimmune joint disease restricted to this study.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02965599	Terminated	Arthritis Rheumatoid	GlaxoSmithKline	2016-12-27	Phase 2

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

Check the GSK3117391 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK3117391 functions as a potent histone deacetylase inhibitor that binds to and inhibits histone deacetylase enzymes, thereby blocking the removal of acetyl groups from lysine residues on histones to alter gene transcription. This epigenetic modulation suppresses downstream pro-inflammatory cytokine expression and immune cell hyperresponsiveness, which serves to reduce tissue-damaging inflammation in clinical conditions such as rheumatoid arthritis.

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>).