FDA

First oral kinase inhibitor OK’d for chronic spontaneous urticaria

October 8, 2025

Brand name: Rhapsido

Generic name: remibrutinib

Manufacturer: Novartis

Approval date: September 30, 2025

FDA has approved Rhapsido (remibrutinib), an oral, small molecule inhibitor of Bruton’s tyrosine kinase (BTK), for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H₁ antihistamine treatment.

Efficacy

Approval was based on results from the phase 3 REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) clinical trials in patients who remained symptomatic on second-generation H₁ antihistamines. Rhapsido demonstrated superiority in change from baseline vs. placebo in itch (ISS7), hives (HSS7), and weekly urticaria activity (UAS7) at week 12. Significantly more patients treated with Rhapsido vs. placebo achieved well-controlled disease (UAS7≤6) as early as week 2 and at week 12, and about one-third of patients achieved complete absence of itch and hives at week 12.

Safety

The most common adverse reactions (incidence >3%) in clinical trials were nasopharyngitis, bleeding, headache, nausea, and abdominal pain.

Recommended dose

The recommended dosage of Rhapsido is 25 mg orally twice daily with or without food. Therapy should be interrupted 3 to 7 days pre- and post-surgery.

Sources:

Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU). [News release]. 2025. https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu

Rhapsido (remibrutinib) [package insert]. Novartis. https://www.novartis.com/us-en/sites/novartis_us/files/rhapsido.pdf Revised September 2025. Accessed October 6, 2025.