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Remibrutinib

Medication used to treat chronic spontaneous urticaria From Wikipedia, the free encyclopedia

Remibrutinib, sold under the brand name Rhapsido, is a medication used for the treatment of chronic spontaneous urticaria.[1] Remibrutinib is an oral, small molecule kinase inhibitor that inhibits Bruton's tyrosine kinase.[1] It is taken by mouth.[1]

Trade namesRhapsido
License data
Quick facts Clinical data, Trade names ...
Remibrutinib
Clinical data
Trade namesRhapsido
AHFS/Drugs.comMonograph
MedlinePlusa625116
License data
Routes of
administration
By mouth
ATC code
Legal status
Legal status
Identifiers
  • N-[3-[6-Amino-5-[2-[methyl(prop-2-enoyl)amino]ethoxy]pyrimidin-4-yl]-5-fluoro-2-methylphenyl]-4-cyclopropyl-2-fluorobenzamide
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
PDB ligand
Chemical and physical data
FormulaC27H27F2N5O3
Molar mass507.542 g·mol−1
3D model (JSmol)
  • CC1=C(C=C(C=C1NC(=O)C2=C(C=C(C=C2)C3CC3)F)F)C4=C(C(=NC=N4)N)OCCN(C)C(=O)C=C
  • InChI=1S/C27H27F2N5O3/c1-4-23(35)34(3)9-10-37-25-24(31-14-32-26(25)30)20-12-18(28)13-22(15(20)2)33-27(36)19-8-7-17(11-21(19)29)16-5-6-16/h4,7-8,11-14,16H,1,5-6,9-10H2,2-3H3,(H,33,36)(H2,30,31,32)
  • Key:CUABMPOJOBCXJI-UHFFFAOYSA-N
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Remibrutinib was approved for medical use in the United States in September 2025,[4] and in the European Union in April 2026.[2][3] The US Food and Drug Administration considers it to be a first-in-class medication.[5][6]

Medical uses

Remibrutinib is indicated for the treatment of chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatment.[1][2]

Side effects

Mechanism of action

Remibrutinib is a selective inhibitor of Bruton's tyrosine kinase, a key signaling protein found in mast cells and basophils that regulates their activation and degranulation via pathways involving the FcεRI and B-cell receptor. By irreversibly binding to Bruton's tyrosine kinase, remibrutinib blocks intracellular signaling required for the release of histamine and other inflammatory mediators, thereby reducing the immune cell-driven processes underlying chronic spontaneous urticaria. This mechanism enables suppression of urticaria symptoms upstream from antihistamines, and may also modulate autoimmune activity in some patients.[8]

Society and culture

Remibrutinib was approved for medical use in the United States in September 2025.[9]

Names

Remibrutinib is the international nonproprietary name.[10]

Remibrutinib is sold under the brand name Rhapsido.[9]

References

Further reading

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