Remibrutinib

Remibrutinib
Clinical data
Trade names	Rhapsido
License data	US DailyMed: Remibrutinib ;
Routes of; administration	By mouth
ATC code	L04AA60 ( WHO );
Legal status
Legal status	US: ℞-only ;
Identifiers
	IUPAC name 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	1787294-07-8 ;
PubChem CID	118107483 ;
IUPHAR/BPS	10457 ;
DrugBank	DB16852 ;
ChemSpider	78317000 ;
UNII	I7MVZ8HDNU ;
ChEMBL	ChEMBL4483575 ;
PDB ligand	N6Z ( PDBe , RCSB PDB );
Chemical and physical data
Formula	C27H27F2N5O3
Molar mass	507.542 g·mol−1
3D model (JSmol)	Interactive image ;
	SMILES 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 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;

Last updated October 04, 2025

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 (BTK).^[1] It is taken by mouth.^[1]

Medical uses

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

Society and culture

Legal status

Remibrutinib was approved for medical use in the United States in September 2025.^[2]

Names

Remibrutinib is the international nonproprietary name.^[3]

Remibrutinib is sold under the brand name Rhapsido.^[2]

References

1 2 3 4 5 https://www.novartis.com/us-en/sites/novartis_us/files/rhapsido.pdf
1 2 "Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU)" (Press release). Novartis Pharmaceuticals. 30 September 2025. Retrieved 1 October 2025– via PR Newswire.
↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl: 10665/339768 .

External links

Clinical trial number NCT05030311 for "A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines (REMIX-1)" at ClinicalTrials.gov
Clinical trial number NCT05032157 for "A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines (REMIX-2)" at ClinicalTrials.gov

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[Rhapsido_FDA_label-1] 1 2 3 4 5 https://www.novartis.com/us-en/sites/novartis_us/files/rhapsido.pdf

[Novartis_PR-2] 1 2 "Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU)" (Press release). Novartis Pharmaceuticals. 30 September 2025. Retrieved 1 October 2025– via PR Newswire.

[3] World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl: 10665/339768 .

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