Novartis has announced positive topline results from its phase 3 REMODEL-1/-2 trials of remibrutinib in Relapsing Multiple Sclerosis (RMS). Remibrutinib, a highly selective and potent oral Bruton’s Tyrosine Kinase (BTK) inhibitor, demonstrated superiority versus teriflunomide in reducing Annualised Relapse Rate (ARR) and inflammatory brain lesions with a favorable safety profile.

The results of the REMODEL trials establish remibrutinib as a BTK inhibitor that achieved significant reductions in ARR across two phase 3 trials in adults with Relapsing Multiple Sclerosis (RMS).  

Remibrutinib demonstrated clinically meaningful reductions versus teriflunomide in key secondary endpoints related to disability progression, with a positive trend in 3-month Confirmed Disability Progression (3mCDP) and nominal significance in 6mCDP in a pre-planned combined analysis of REMODEL-1/-2.

The safety profile in REMODEL-1/-2 was consistent with the broader development program of remibrutinib comprising more than 4,500 clinical trial participants in multiple indications.

 Remibrutinib was well tolerated and continues to demonstrate no liver safety signal, including no cases meeting Hy’s Law criteria.  

Shreeram Aradhye, President, Development, and Chief Medical Officer (CMO), Novartis, said, “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. 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 present the REMODEL-1 and REMODEL-2 data as a late-breaker at MSToronto2026 and intends to host an investor call following the congress presentation. Novartis plans to seek regulatory approval for remibrutinib in RMS globally.