GlaxoSmithKline has sponsored multiple clinical trials evaluating GSK256066 for the treatment of inflammatory respiratory disorders, specifically seasonal allergic rhinitis, asthma, and chronic obstructive pulmonary disease. These completed, industry-led Phase I and Phase II studies focused on assessing the drug's safety, tolerability, and therapeutic efficacy.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT00549679 | COMPLETED | Pulmonary Disease, Chronic Obstructive |
GlaxoSmithKline |
2007-10-04 | PHASE2 |
| NCT00549744 | COMPLETED | Asthma |
GlaxoSmithKline |
2007-11-16 | PHASE2 |
| NCT00612118 | COMPLETED | Allergic Rhinitis; Rhinitis, Allergic, Seasonal |
GlaxoSmithKline |
2008-02 | PHASE2 |
| NCT00612820 | COMPLETED | Rhinitis, Allergic, Seasonal |
GlaxoSmithKline |
2008-01 | PHASE2 |
| NCT00515268 | COMPLETED | Pulmonary Disease, Chronic Obstructive |
GlaxoSmithKline |
2007-09-27 | PHASE1 |
| NCT00612118 | Completed | Allergic Rhinitis|Rhinitis Allergic Seasonal |
GlaxoSmithKline |
2008-02 | Phase 2 |
| NCT00612820 | Completed | Rhinitis Allergic Seasonal |
GlaxoSmithKline |
2008-01 | Phase 2 |
| NCT00549744 | Completed | Asthma |
GlaxoSmithKline |
2007-11-16 | Phase 2 |
| NCT00549679 | Completed | Pulmonary Disease Chronic Obstructive |
GlaxoSmithKline |
2007-10-04 | Phase 2 |
| NCT00515268 | Completed | Pulmonary Disease Chronic Obstructive |
GlaxoSmithKline |
2007-09-27 | Phase 1 |
| NCT00464568 | COMPLETED | Rhinitis, Allergic, Seasonal |
GlaxoSmithKline |
2007-03-28 | PHASE2 |
| NCT00464568 | Completed | Rhinitis Allergic Seasonal |
GlaxoSmithKline |
2007-03-28 | Phase 2 |
| NCT00377728 | COMPLETED | Rhinitis, Allergic, Seasonal; Seasonal Allergic Rhinitis |
GlaxoSmithKline |
2006-03 | PHASE2 |
| NCT00430157 | COMPLETED | Rhinitis, Allergic, Seasonal; Seasonal Allergic Rhinitis |
GlaxoSmithKline |
2007-01 | PHASE2 |
| NCT00380354 | COMPLETED | Asthma; Mild Asthma |
GlaxoSmithKline |
2006-09 | PHASE2 |
| NCT00445510 | COMPLETED | Asthma |
GlaxoSmithKline |
2006-06 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2017-07-28)
Check the
GSK256066
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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.