Clinical Trials

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.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK256066 is an exceptionally potent and selective phosphodiesterase 4 inhibitor that binds PDE4B with picomolar affinity to block cyclic AMP degradation, thereby elevating intracellular cAMP levels and suppressing lipopolysaccharide-induced tumor necrosis factor production. This cellular inhibition reduces inflammatory leukocyte infiltration and pulmonary airway inflammation, providing therapeutic utility in clinical trial conditions such as asthma, allergic rhinitis, and chronic obstructive pulmonary 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.