filgotinibi

Filgotibi, also known by its development code GLPG0634, is a selective inhibitor of the enzyme JAK1 (Janus kinase 1). As an oral small-molecule medication, it is designed to interfere with signaling pathways driven by cytokines that rely on JAK1, with the aim of reducing inflammation while potentially sparing some functions of other JAK family members.

In clinical development, filgotibi has been studied for autoimmune and inflammatory diseases such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, and psoriatic arthritis. Phase III trials have reported improvements in disease activity and patient-reported outcomes for some indications, though results have varied across conditions. The drug is administered as an oral tablet, and dosing in trials has included regimens around 100 mg or 200 mg once daily, depending on the indication and region.

Safety and tolerability data for JAK inhibitors in general emphasize risks such as infections, changes in lipid levels, and liver enzyme elevations, with rare but serious events including thrombotic events. Filgotibi-specific safety assessments have included reproductive effects observed in preclinical studies and ongoing evaluation through post-marketing surveillance where applicable.

Regulatory status varies by country and region. Some authorities have approved filgotibi for certain inflammatory diseases, while others have paused, restricted, or requested additional safety data before making a decision. The regulatory landscape continues to evolve as more clinical data become available.

See also: JAK inhibitors, inflammatory diseases, rheumatoid arthritis.