Oral BTK inhibitor remibrutinib outperforms standard MS therapy in twin phase III trials

A new oral therapy for relapsing multiple sclerosis (MS) is showing impressive results. Remibrutinib, a highly selective Bruton's tyrosine kinase (BTK) inhibitor developed by Novartis, significantly reduced annualized relapse rates compared to teriflunomide (Aubagio) in two identical phase III trials — REMODEL-1 and REMODEL-2 — presented at MSToronto2026 and simultaneously published in The Lancet. The reductions translated to roughly one relapse every 13 years for patients on remibrutinib.

Beyond relapse rates, the drug also showed strong MRI outcomes and a cleaner safety profile than some of its BTK inhibitor peers — notably, no liver safety signal emerged, a concern that has shadowed other drugs in this class. Novartis plans to seek global regulatory approval for remibrutinib in relapsing MS.

By the Numbers:

• ARR reduced by 35.2% (REMODEL-1) and 31.2% (REMODEL-2) vs. teriflunomide
• New/enlarging T2 brain lesions reduced by 65–70% vs. teriflunomide
• Gadolinium-enhancing lesions reduced by 66% in both trials
• 6-month confirmed disability progression reduced by 29.2% (nominal significance)
• Pooled NEDA-3 (no evidence of disease activity) rate: 55.0% vs. 32.1% with teriflunomide
• Treatment discontinuations due to adverse events: 3.1% (remibrutinib) vs. 5.8% (teriflunomide)

Why it matters: Remibrutinib offers a promising oral option for relapsing MS with high efficacy and a favorable safety profile — particularly its lack of liver toxicity, which has been a sticking point for other BTK inhibitors. If approved, it could become a meaningful new addition to the MS treatment landscape.