Game Changer: FDA Approves Rhapsido (Remibrutinib), the First Oral BTK Inhibitor for Chronic Hives (CSU)

FDA approval of Rhapsido (remibrutinib), the first oral BTK inhibitor pill for chronic spontaneous urticaria (CSU).

For years, patients with chronic spontaneous urticaria (CSU) who didn’t respond to antihistamines had only injections as the next step. On September 30, 2025, the U.S. Food and Drug Administration (FDA) approved remibrutinib (brand name Rhapsido), the first oral BTK inhibitor for adults with CSU. This approval offers patients — and doctors — the first convenient oral option beyond antihistamines. What Is Chronic Spontaneous Urticaria (CSU)? Why an Oral Option Matters Until now, patients had only these alternatives: Patients have long asked for a safe oral treatment that avoids injections…

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