Clinical Trials

Orelabrutinib Achieves Primary Endpoint in Phase 2b SLE Trial

HCPLive Dec 15, 2025

InnoCare Pharma announced that Orelabrutinib, a BTK inhibitor, achieved its primary endpoint in a Phase 2b study for Systemic Lupus Erythematosus (SLE). At week 48, there was a statistically significant improvement in SRI-4 response rate among patients receiving orelabrutinib 75 mg once daily compared with placebo (57.1% vs 34.4%; P <.05), leading to phase 3 trial approval.

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