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In September 2025, the U.S. Food and Drug Administration approved remibrutinib (Rhapsido) for the treatment of chronic spontaneous urticaria in adults who remain symptomatic despite H1-antihistamine treatment.
Chronic spontaneous urticaria is caused by autoantibodies that bind to IgE receptors on mast cells, leading to their activation and degranulation. Remibrutinib is an oral, small-molecule Bruton tyrosine kinase (BTK) inhibitor that reduces this intracellular signaling pathway.
In the two phase 3 trials that led to FDA approval, more than 900 adults with chronic spontaneous urticaria that was not controlled with antihistamines were randomized to receive twice-daily oral remibrutinib or placebo for 1 year. Patients ex…