Novartis's oral BTK inhibitor remibrutinib cuts MS relapse rates by up to 35% in phase 3 trials

A new oral treatment for relapsing multiple sclerosis (MS) is making waves. Novartis's remibrutinib — a highly selective, covalent Bruton tyrosine kinase (BTK) inhibitor — significantly outperformed teriflunomide in two identical phase 3 trials, REMODEL-1 and REMODEL-2, enrolling over 2,000 patients globally. The results were presented at MSToronto2026 and simultaneously published in The Lancet.

Beyond cutting relapse rates, remibrutinib also showed meaningful benefits on disability progression and brain lesion activity. More than 92% of patients on remibrutinib remained free of 6-month confirmed disability progression over 24 months, and MRI outcomes consistently favored the drug. Novartis now plans to pursue global regulatory approval for remibrutinib in relapsing MS.

By the Numbers:

• 35.2% reduction in annualized relapse rate (ARR) in REMODEL-1 vs. teriflunomide
• 31.2% reduction in ARR in REMODEL-2 vs. teriflunomide
• ~1 relapse every 13 years with remibrutinib, per Novartis estimates
• 55.0% vs. 32.1% pooled NEDA-3 (no evidence of disease activity) rate
• Liver enzyme elevations (ALT >3x ULN): 2.0% with remibrutinib vs. 7.4% with teriflunomide
• Discontinuations due to adverse events: 3.1% vs. 5.8%

Why it matters: Oral therapies that combine high efficacy with a clean safety profile are a major unmet need in MS care. Remibrutinib's strong performance — including no liver safety signal — could position it as a compelling alternative to existing treatments, giving patients and clinicians a new, convenient option.