Clinical Trials

Multiple Phase 1 clinical trials sponsored by GlaxoSmithKline have evaluated GSK2292767 for the treatment of asthma, all of which have reached completed recruitment status. These studies primarily aimed to assess the safety, tolerability, and pharmacokinetic profile of single and repeat doses of the compound to determine its suitability for managing respiratory inflammatory conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03045887 COMPLETED
Asthma
GlaxoSmithKline
2017-02-06 PHASE1
NCT03045887 Completed
Asthma
GlaxoSmithKline
2017-02-06 Phase 1

(data from https://clinicaltrials.gov, updated on 2019-07-24)

Check the GSK2292767 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK2292767 functions as a potent and selective inhibitor of phosphoinositide 3-kinase delta (PI3Kδ), binding to the catalytic subunit to block the phosphorylation of phosphatidylinositol 4,5-bisphosphate and suppress downstream AKT signaling cascades. This targeted enzymatic inhibition decreases the activation, proliferation, and mediator release of immune cells such as lymphocytes and eosinophils, thereby mitigating chronic airway inflammation relevant to the clinical management of asthma.

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.