Clinical Trials

Multiple clinical trials sponsored by Lakefront Biotherapeutics NV have evaluated GLPG3970 across Phase 1 and Phase 2 development. Phase 1 trials assessed safety, tolerability, pharmacokinetics, pharmacodynamics, bioavailability, and drug-drug interactions in healthy subjects as well as patients with psoriasis or systemic lupus erythematosus, whereas Phase 2 trials evaluated efficacy and safety in rheumatoid arthritis, ulcerative colitis, and primary Sjögren syndrome. Although several trials completed recruitment, studies evaluating primary Sjögren syndrome and systemic lupus erythematosus were terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04700280 TERMINATED
Primary Sjögren Syndrome
Lakefront Biotherapeutics NV
 2021-01-28 PHASE2
NCT04700267 TERMINATED
Systemic Lupus Erythematosus
Lakefront Biotherapeutics NV
 2020-12-28 PHASE1
NCT04907149 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2021-06-07 PHASE1
NCT04577794 COMPLETED
Ulcerative Colitis
Lakefront Biotherapeutics NV
 2020-10-05 PHASE2
NCT04720183 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2021-01-11 PHASE1
NCT04577781 COMPLETED
Rheumatoid Arthritis
Lakefront Biotherapeutics NV
 2020-10-12 PHASE2
NCT04106297 COMPLETED
Healthy; Psoriasis
Lakefront Biotherapeutics NV
 2019-09-10 PHASE1
NCT04708184 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2021-01-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2023-09-18)

Check the GLPG3970 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GLPG3970 functions as a potent dual inhibitor of salt-inducible kinases 2 and 3 (SIK2 and SIK3) with IC50 values of 7.8 nM and 3.8 nM, respectively, binding these targets to block downstream kinase phosphorylation pathways. By modulating transcription factor activity and suppressing pro-inflammatory cytokine secretion, this kinase inhibition mitigates aberrant immune cell activation, providing therapeutic relevance for inflammatory and autoimmune conditions such as rheumatoid arthritis, ulcerative colitis, and psoriasis.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.