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SEP 3 2026
UPCOMING · 34 DAYS TO PDUFA

Priovant Therapeutics brepocitinib

for dermatomyositis

NDA · Priority Review

About

Dermatomyositis is a long-term autoimmune disease that causes a distinctive skin rash and progressive muscle weakness, which can severely limit movement and daily activities. Brepocitinib is an oral drug designed to block two key enzymes inside immune cells, TYK2 and JAK1, which are involved in sending inflammatory signals. By quieting this overactive signaling, the drug may reduce the skin and muscle inflammation that drives the disease's debilitating symptoms.

Pivotal trial

VALOR Phase 3 active not recruiting NCT05437263

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS)

Source: ClinicalTrials.gov

Also in development