Clinical Trials

GlaxoSmithKline has sponsored multiple clinical trials evaluating Danirixin (GSK1325756) across Phase 1 and Phase 2 studies for indications including chronic obstructive pulmonary disease, viral diseases, respiratory tract infections, respiratory syncytial virus, and nutritional status. Early-phase trials assessed pharmacokinetics and bioavailability in healthy volunteers, whereas Phase 2 trials evaluated safety and clinical efficacy in patient cohorts. Trial outcomes comprise both successfully completed studies and terminated investigations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03170232 TERMINATED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2017-10-16 PHASE2
NCT03250689 TERMINATED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2017-11-15 PHASE2
NCT03034967 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2017-04-25 PHASE2
NCT03457727 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2018-03-07 PHASE1
NCT03457727 Completed
Pulmonary Disease Chronic Obstructive
GlaxoSmithKline
 2018-03-07 Phase 1
NCT03136380 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2017-05-10 PHASE1
NCT02927431 TERMINATED
Virus Diseases
GlaxoSmithKline
 2017-01-19 PHASE2
NCT03136380 Completed
Pulmonary Disease Chronic Obstructive
GlaxoSmithKline
 2017-05-10 Phase 1
NCT02130193 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2014-02-13 PHASE2
NCT02469298 COMPLETED
Virus Diseases
GlaxoSmithKline
 2015-06-01 PHASE2
NCT02453022 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2015-05-18 PHASE1
NCT02201303 COMPLETED
Infections, Respiratory Syncytial Virus
GlaxoSmithKline
 2014-01-13 PHASE1
NCT02169583 COMPLETED
Infections, Respiratory Tract
GlaxoSmithKline
 2014-06-12 PHASE1
NCT01453478 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2011-10-12 PHASE1
NCT01267006 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2010-11-05 PHASE1
NCT01209104 COMPLETED
Nutritional Status
GlaxoSmithKline
 2010-04-14 PHASE1
NCT01209052 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2009-10-15 PHASE1

(data from https://clinicaltrials.gov, updated on 2020-07-31)

Check the Danirixin (GSK1325756) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Danirixin (GSK1325756) acts as a selective and reversible CXCR2 antagonist that inhibits CXCL8 ligand binding to block downstream signal transduction and neutrophil activation. By reducing neutrophil-mediated inflammatory processes and lung tissue damage, this inhibition targets key pathological pathways evaluated in clinical trials for chronic obstructive pulmonary disease and viral respiratory infections.

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.