GSK3179106 Clinical Trials

Size	Price	Qty
2mg	USD 147

Clinical Trials

A completed Phase 1 clinical trial sponsored by GlaxoSmithKline evaluated the therapeutic potential of GSK3179106 in human subjects with Irritable Bowel Syndrome. Utilizing a randomized, placebo-controlled crossover design, this industry-led study assessed the safety, tolerability, and pharmacokinetic profile of the molecule following ascending doses. Overall, this early-stage investigation established the initial clinical translation and safety profile of GSK3179106 for targeted gastrointestinal conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02727283	Completed	Irritable Bowel Syndrome	GlaxoSmithKline	2015-11-26	Phase 1

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

Check the GSK3179106 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK3179106 functions as a potent, selective, and gut-restricted pyridone hinge binder that directly inhibits RET kinase activity, thereby suppressing downstream intracellular phosphorylation and signaling cascades. This targeted inhibition modulates enteric neural signaling within the gastrointestinal tract, providing the pharmacological rationale for its clinical evaluation in conditions such as Irritable Bowel Syndrome.

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>).