# Novartis remibrutinib clinical development

> Live situation record from CLSTR: https://clstr.news/situations/novartis-remibrutinib-clinical-development
> Updated: 2026-10-23T16:51:41.000Z. Sources: 11. Developments: 2.

Novartis is advancing the clinical application of remibrutinib, an oral Bruton tyrosine kinase (BTK) inhibitor, across different medical indications.

In October 2026, the US Food and Drug Administration (FDA) approved remibrutinib (brand name Rhapsido) for adults with symptomatic dermographism (SD) that is not adequately controlled by H1 antihistamines. This represents the first approved therapy specifically for SD. The approval followed phase 3 RemIND clinical trial data showing that 29.3% of patients on a 25 mg twice-daily dose achieved a complete response from hives at week 12. This approval expands the drug's indications, as it was previously approved in 2025 for chronic spontaneous urticaria (CSU), making it the only agent indicated for both conditions.

Concurrently, Novartis reported Phase III trial results for remibrutinib in treating multiple sclerosis (MS). Data from the REMODEL-1 and REMODEL-2 trials indicated that a 100 mg dose reduced annualized relapse rates by 35.2% and 31.2%, respectively, compared to teriflunomide. While these efficacy results were lower than some market analyst expectations—which had projected improvements between 45% and 60%—Novartis noted that the drug did not exhibit the liver safety signals associated with other treatments in this class. The company intends to seek global regulatory approval for its use in relapsing MS.

## Timeline

### 2026-10-23: Novartis remibrutinib reduces multiple sclerosis relapse rates

Novartis' remibrutinib reduced multiple sclerosis relapse rates by approximately 31% to 35% in Phase III trials, performing well against comparators but below some analyst expectations.

6 sources. https://clstr.news/cluster/novartis-reports-ms-drug-remibrutinib-relapse-reduction-data

### 2026-10-07: FDA approves Novartis's remibrutinib for symptomatic dermographism

The FDA has approved Novartis's remibrutinib (Rhapsido) for adults with symptomatic dermographism inadequately controlled by antihistamines, making it the first therapy specifically for this condition.

5 sources. https://clstr.news/cluster/fda-approves-remibrutinib-for-symptomatic-dermographism

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Cite as: Novartis remibrutinib clinical development. CLSTR, https://clstr.news/situations/novartis-remibrutinib-clinical-development