Novartis has said that its oral BTK inhibitor remibrutinib delivered positive topline results in two Phase III trials, showing superiority over teriflunomide in reducing annualized relapse rates and inflammatory brain lesions in adults with relapsing multiple sclerosis (RMS).
The REMODEL-1 and REMODEL-2 trials establish remibrutinib as a highly selective and potent Bruton’s tyrosine kinase (BTK) inhibitor that significantly reduced annualized relapse rates across two Phase III studies. The drug also demonstrated a favorable safety profile.
The results point to potential benefits beyond relapse control. In a preplanned combined analysis of REMODEL-1 and REMODEL-2, remibrutinib showed clinically meaningful reductions versus teriflunomide on key secondary endpoints related to disability progression, including a positive trend in 3-month confirmed disability progression (3mCDP) and nominal significance in 6-month confirmed disability progression (6mCDP).
Safety findings were consistent with the broader remibrutinib development program, which includes more than 4,500 clinical trial participants across multiple indications. Novartis said remibrutinib was well tolerated and continued to show no liver safety signal, with no cases meeting Hy’s Law criteria.
“Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention, slow disability progression, while maintaining a favorable safety profile. The positive REMODEL results underscore the potential of remibrutinib as a high-efficacy oral therapy for people living with RMS with a differentiated benefit-risk profile,” said Shreeram Aradhye, President, Development, and Chief Medical Officer, Novartis.
“Building on our long-standing commitment to advancing care in MS, these findings reinforce our continued ambition on driving innovation in this space and delivering therapies that address the evolving needs of people living with MS.”
Novartis will unveil detailed REMODEL-1 and REMODEL-2 data as a late-breaker at MSToronto2026. The company also plans to host an investor call following the congress presentation.
With the Phase III results in hand, Novartis said it plans to seek regulatory approval for remibrutinib in RMS globally.
