GLPG3312 Clinical Trials

Size	Price	Qty
1mg	USD 197
5mg	USD 347

Clinical Trials

The clinical evaluation of GLPG3312, a small-molecule inhibitor, currently comprises a clinical trial sponsored by industry developer Lakefront Biotherapeutics NV. This completed Phase 1 study assessed the safety, tolerability, and pharmacokinetic profile of the compound in healthy subjects, establishing foundational human safety parameters. Currently, no clinical trials targeting specific inflammatory conditions or patient populations have been registered.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03800472	COMPLETED	Healthy	Lakefront Biotherapeutics NV	2019-01-15	PHASE1

(data from https://clinicaltrials.gov, updated on 2020-03-19)

Check the GLPG3312 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GLPG3312 functions as a potent pan-salt-inducible kinase inhibitor that binds SIK1, SIK2, and SIK3, thereby suppressing downstream inflammatory signal transduction and modulating cytokine expression in immune cells. This targeted modulation of immunoregulatory pathways provides the rationale for evaluating the pharmacological activity, tolerability, and safety profile of GLPG3312 in healthy subjects within early-stage clinical trials.

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>).