Abstract: Chronic spontaneous urticaria(CSU)is a common mast cell-mediated skin disease. However, most patients respond poorly to current antihistamines, and the second-line treatment omalizumab also shows poor response or fails to achieve complete remission. Therefore, safe, effective, and convenient new drugs are still needed. Remibrutinib is an oral, highly selective inhibitor of Bruton's tyrosine kinase(BTK). On September 30, 2025, it was approved by the U.S. Food and Drug Administration for the treatment of adult patients with CSU who remain symptomatic after antihistamine therapy, becoming the first BTK inhibitor globally approved for CSU. The drug was subsequently approved for marketing in China by the National Medical Products Administration on November 25, 2025. By irreversibly inhibiting BTK activity, remibrutinib specifically blocks downstream signal transduction triggered by IgE receptor cross-linking, thereby inhibiting mast cell and basophil degranulation, reducing the release of inflammatory mediators such as histamine, and effectively alleviating wheals and pruritus. Phase III clinical trials have shown that remibrutinib can rapidly and significantly improve patients symptoms and maintain efficacy for up to 52 weeks, with a favorable safety profile. However, its long-term efficacy and safety in different racial populations still require further observation. This article briefly reviews the mechanism of action, pharmacokinetic characteristics, clinical research, and safety of remibrutinib, aiming to provide a reference for the clinical treatment and new drug development of CSU in China.

Key words: Remibrutinib, Chronic spontaneous urticaria, Brutons tyrosine kinase inhibitor, Oral therapy