GSK3145095 Clinical Trials

Size	Price	Qty
5mg	USD 370
25mg	USD 970

Clinical Trials

GSK3145095 has been evaluated in several clinical trials primarily focused on the treatment of pancreatic neoplasms. In a representative Phase 1/2 study sponsored by GlaxoSmithKline in collaboration with Parexel, researchers investigated the safety, clinical activity, pharmacokinetics, and pharmacodynamics of the molecule both as a single agent and in combination therapy. However, recruitment for this early-phase evaluation was ultimately terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03681951	TERMINATED	Neoplasms, Pancreatic	GlaxoSmithKline	2018-11-16	PHASE2
NCT03681951	Terminated	Neoplasms Pancreatic	GlaxoSmithKline\|Parexel	2018-11-16	Phase 2

(data from https://clinicaltrials.gov, updated on 2020-07-31)

Check the GSK3145095 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK3145095 selectively binds to and inhibits receptor-interacting protein 1 (RIP1) kinase with an IC50 of 6.3 nM, thereby blocking pro-inflammatory necroptotic signaling cascades and downstream cytokine production within target cells. By suppressing necroptosis and modulating tumor-associated inflammation, this agent aims to alter the immunosuppressive microenvironment to exert antineoplastic activity in pancreatic neoplasms.

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>).