Clinical Trials

GSK2256098 has been evaluated in multiple Phase 1 and Phase 2 clinical trials for oncology and cardiovascular conditions, sponsored by GlaxoSmithKline alongside academic networks like the University Health Network, Toronto, and the Alliance for Clinical Trials in Oncology. Target indications include pulmonary arterial hypertension, advanced solid neoplasms, pancreatic cancer, adenocarcinoma, and recurrent or intracranial meningiomas harboring NF2 gene mutations. Although several early-phase trials assessing safety, pharmacokinetics, and combination regimens are completed, active studies remain recruiting to establish efficacy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02523014 RECRUITING
Intracranial Meningioma; Recurrent Meningioma; NF2 Gene Mutation
Alliance for Clinical Trials in Oncology
 2015-09-28 PHASE2
NCT02428270 COMPLETED
Pancreatic Cancer; Adenocarcinoma
University Health Network, Toronto
 2016-04 PHASE2
NCT02551653 COMPLETED
Hypertension, Pulmonary
GlaxoSmithKline
 2015-11-17 PHASE1
NCT01938443 COMPLETED
Cancer; Neoplasms
GlaxoSmithKline
 2013-11-18 PHASE1
NCT01138033 COMPLETED
Cancer
GlaxoSmithKline
 2010-07-27 PHASE1
NCT02551653 Completed
Hypertension Pulmonary
GlaxoSmithKline
 2015-11-17 Phase 1
NCT01938443 Completed
Cancer|Neoplasms
GlaxoSmithKline
 2013-11-18 Phase 1
NCT01138033 Completed
Cancer
GlaxoSmithKline
 2010-07-27 Phase 1
NCT00996671 COMPLETED
Cancer
GlaxoSmithKline
 2009-11-06 PHASE1
NCT00996671 Completed
Cancer
GlaxoSmithKline
 2009-11-06 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-09-02)

Check the GSK2256098 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK2256098 functions as a potent, reversible, ATP-competitive focal adhesion kinase (FAK) inhibitor with an apparent Ki of 0.4 nM, blocking downstream FAK-mediated autophosphorylation and intracellular signaling pathways required for cancer cell growth and survival. By suppressing focal adhesion signaling and inducing tumor cell apoptosis, this target inhibition provides the biological rationale for its clinical evaluation in advanced solid malignancies, meningiomas, and pulmonary hypertension.

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>).

Jump to

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