Novartis has released phase 3 trial results for remibrutinib, showing that the oral drug significantly reduces annualized relapse rates in relapsing multiple sclerosis (RMS).
Remibrutinib is a high-efficacy, highly-selective, potent Bruton’s tyrosine kinase (BTK) inhibitor. It modulates immune regulatory networks and neuroinflammation by preventing the activation of B cells and innate immune cells. It received FDA approval in September 2025 as Rhapsido for adults with chronic spontaneous uticaria.
In the REMODEL-1/-2 trials, remibrutinib met its primary endpoint, demonstrating a clinically-meaningful reduction in annualized relapse rate (ARR) compared with teriflunomide. It also met all its key secondary endpoints, including reducing inflammatory brain lesions, and showed a safety profile consistent with CSU.