Clinical Trials

Multiple Phase I clinical trials sponsored by GlaxoSmithKline evaluated GSK2983559 for the potential treatment of inflammatory bowel diseases, focusing on safety, tolerability, and pharmacokinetics. However, recruitment across these early-stage studies was prematurely terminated, restricting the candidate's clinical profile to halted Phase I investigations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03358407 TERMINATED
Inflammatory Bowel Diseases
GlaxoSmithKline
 2018-01-11 PHASE1
NCT03358407 Terminated
Inflammatory Bowel Diseases
GlaxoSmithKline
 2018-01-11 Phase 1

(data from https://clinicaltrials.gov, updated on 2020-11-27)

Check the GSK2983559 (compound 3) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK2983559 acts as a potent and selective inhibitor of receptor-interacting protein 2 (RIP2) kinase, binding to the ATP-binding site of RIP2 to block downstream NF-κB and MAPK signaling cascades required for pro-inflammatory cytokine release. By inhibiting RIP2-mediated signaling pathways, this compound reduces cellular inflammatory responses, which is directly relevant to suppressing gastrointestinal tissue damage in inflammatory bowel diseases.

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>).

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