By: IPP Bureau
Last updated : October 25, 2026 6:12 pm
Novartis has reported positive results from two pivotal Phase III trials of remibrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, demonstrating significantly lower relapse rates and a clinically meaningful delay in disability progression in people with relapsing multiple sclerosis (RMS).
The findings position remibrutinib as a potential new treatment option for patients seeking sustained disease control without chronic B-cell depletion.
Results from the REMODEL-1 and REMODEL-2 trials show remibrutinib achieved a statistically significant reduction in annualized relapse rate (ARR) compared with teriflunomide, meeting the primary endpoint of both studies.
The findings also point to a potential benefit beyond relapse prevention. Remibrutinib reduced the risk of six-month confirmed disability progression (6mCDP) by 29.2%, with nominal statistical significance, and showed a consistent positive trend towards a 20.5% reduction in three-month confirmed disability progression (3mCDP).
More than 92% of patients receiving remibrutinib remained free from disability progression over 24 months, as measured by 6mCDP.
“The REMODEL trial results showed that oral remibrutinib delivered a significant reduction in relapse activity while also showing a clinically meaningful effect on confirmed disability progression in people living with relapsing MS,” said Prof. Heinz Wiendl, Professor of Neurology and Chair of the Department of Neurology and Neurophysiology at the Medical Center, University of Freiburg.
“As treatment goals in MS continue to evolve beyond relapse control alone, these efficacy findings, together with the favorable safety profile, suggest remibrutinib has the potential to deliver a meaningful, differentiated treatment option for people living with RMS.”
Beyond efficacy, Novartis highlighted remibrutinib’s liver safety profile as a potentially important differentiator. The trials reported no liver safety signal, including no cases of Hy’s Law, a combination of laboratory findings that can indicate serious drug-induced liver injury.
Across both studies, liver enzyme elevations were less frequent with remibrutinib than with teriflunomide at every reported threshold. Elevations in alanine aminotransferase (ALT) exceeding three times the upper limit of normal (ULN) occurred in 2.0% of patients receiving remibrutinib, compared with 7.4% of those treated with teriflunomide.
Novartis said the ALT elevation rate with remibrutinib was within the range observed in placebo groups in previous RMS trials. In pooled analyses, discontinuations due to adverse events were also nearly 50% lower with remibrutinib than with teriflunomide, at 3.1% versus 5.8%.
While these results support a favorable safety profile in the trials, longer-term follow-up and broader clinical experience will be important to establish the treatment’s safety profile over extended use.
What the results mean for MS treatment
The REMODEL findings add to the evolving treatment landscape in RMS, where the focus is increasingly shifting beyond reducing relapses towards preventing long-term disability while maintaining an acceptable safety profile.
The relapse reductions across both Phase III trials, together with the disability progression findings and lower rates of liver enzyme elevations, provide a substantial clinical rationale for further evaluating remibrutinib as a treatment option.