Remibrutinib is a Bruton's tyrosine kinase inhibitor used to treat chronic spontaneous urticaria in adults. The FDA approved remibrutinib on September 30, 2025 as the only oral, targeted treatment for chronic spontaneous urticaria.
- Mechanism
- Curator reviewed · 4 references
Remibrutinib is an oral, small molecule that inhibits Bruton’s tyrosine kinase (BTK). BTK is an intracellular protein expressed in mast cells, basophils, B cells, macrophages, and thrombocytes, and is involved in intracellular signaling via Fc epsilon receptor-1 (FcεR1), Fc gamma receptors (FcγR), and the B cell antigen receptor (BCR). BTK signalling has been implicated in the pathophysiology of chronic spontaneous urticaria by releasing pro-inflammatory mediators. Remibrutinib also inhibits the BTK-related kinases TEC protein tyrosine kinase (TEC) and BMX non-receptor tyrosine kinase (BMX).
- Primary indication
- Remibrutinib is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.Curator reviewed · 2 structured indications
- Formula / weight
- C27H27F2N5O3 · 507.542 g/mol (avg)
- First approval
- Canada, 2026 · United States, 2025
- Code names
- LOU-064 · LOU064-NXA · LOU64 · NVP-LOU064-NXA
- Brand names
Resolves to
CUABMPOJOBCXJI-UHFFFAOYSA-NSMILESCN(CCOC1=C(N)N=CN=C1C1=C(C)C(NC(=O)C2=C(F)C=C(C=C2)C2CC2)=CC(F)=C1)C(=O)C=CWhat you can answer from here — as of September 13, 2026
Which drugs share a target with Remibrutinib, and which of those have an active Phase 3 trial?
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