Envudeucitinib for Systemic Lupus Erythematosus (SLE)

Envudeucitinib (“envu”), formerly known as ESK-001, is a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor designed to correct immune dysregulation across a range of diseases, including SLE, the most common form of lupus. By selectively targeting key proinflammatory mediators, including type 1 interferon (IFN), it aims to deliver maximal inhibition while minimizing off-target effects.

Promising Data

Early data indicate that envu downregulates key cytokines and disease biomarkers of SLE, effectively disrupting pro-inflammatory pathways and potentially reducing disease activity. In Phase 1 studies, it demonstrated full, sustained target inhibition and was well tolerated in healthy volunteers.

These promising data, along with envu’s ability to achieve maximal TYK2 inhibition in patients with psoriasis, suggest it could become a high-efficacy oral treatment for SLE. Building on these findings, we initiated the Phase 2 LUMUS trial—a global, multicenter study evaluating the efficacy, safety, and pharmacokinetics of multiple envu doses in adults with moderately to severely active, autoantibody-positive SLE. Topline data from the Phase 2 LUMUS trial is expected in 2026.

Envu is also in development for moderate to severe plaque psoriasis, with potential future indications in psoriatic arthritis, inflammatory bowel disease, and other chronic inflammatory conditions.