Clinical Trials

Several clinical trials evaluate therapeutic interventions across indications such as systemic lupus erythematosus, non-alcoholic fatty liver disease, idiopathic pulmonary fibrosis, Parkinson disease, and uterine corpus carcinoma associated with Lynch syndrome. Spanning Phase 1, Phase 1/2, Phase 2, and unassigned stages, these studies aim to determine safety, pharmacokinetics, and therapeutic efficacy. Sponsored by industry, academic, and government entities—including GlaxoSmithKline, the National Cancer Institute, the Gynecologic Oncology Group, and the State University of New York at Buffalo—recruitment statuses range from not yet recruiting to actively recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01199250 Not yet recruiting
Lynch Syndrome|Recurrent Uterine Corpus Carcinoma|Stage I Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation
2100-01 --
NCT06339034 Not yet recruiting
Parkinson Disease
State University of New York at Buffalo|The Cure Parkinson''s Trust
2024-06 Phase 1|Phase 2
NCT06317285 Not yet recruiting
Idiopathic Pulmonary Fibrosis
GlaxoSmithKline
2024-04-01 Phase 2
NCT06104319 Recruiting
Non-alcoholic Fatty Liver Disease
GlaxoSmithKline
2024-01-22 Phase 2
NCT06188507 Not yet recruiting
Systemic Lupus Erythematosus
GlaxoSmithKline
2024-01-11 Phase 1

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

Check the GSK'547 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK'547 is a potent and highly selective inhibitor of receptor-interacting serine/threonine-protein kinase 1 (RIPK1) that blocks kinase activation and prevents downstream necroptotic signaling pathways mediated by MLKL. By suppressing RIPK1-dependent programmed necrosis and pro-inflammatory signaling cascades, GSK'547 reduces tissue inflammation and cellular damage relevant to clinical indications such as systemic lupus erythematosus, idiopathic pulmonary fibrosis, and non-alcoholic fatty liver disease.

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>).

Note: Technical data last updated: Sep 1, 2026.