Clinical Trials

GlaxoSmithKline has sponsored multiple Phase 1 clinical trials to evaluate GSK-3008348 for idiopathic pulmonary fibrosis. A clinical trial evaluating the safety and tolerability of the compound in healthy volunteers and patients was completed, whereas a clinical trial investigating the safety, pharmacokinetics, and target engagement of a nebulized formulation was terminated. Together, these clinical trials highlight early-stage research into the compound's therapeutic potential for fibrotic lung disease.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03069989 TERMINATED
Idiopathic Pulmonary Fibrosis
GlaxoSmithKline
 2017-06-13 PHASE1
NCT02612051 COMPLETED
Idiopathic Pulmonary Fibrosis
GlaxoSmithKline
 2015-12-04 PHASE1

(data from https://clinicaltrials.gov, updated on 2019-08-12)

Check the GSK-3008348 HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK-3008348 HCl acts as a potent small-molecule antagonist that selectively binds to integrin αvβ6, thereby blocking cell adhesion and inhibiting downstream pro-fibrotic signaling pathways. By disrupting these αvβ6-mediated cellular interactions and downstream fibrotic responses, the compound attenuates pathological tissue remodeling, providing a rationale for its clinical evaluation in idiopathic pulmonary fibrosis.

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.