Remibrutinib Reduced Relapses in Phase 3 Relapsing MS Trials

Remibrutinib significantly reduced annualized relapse rates compared with teriflunomide in adults with relapsing multiple sclerosis (RMS) in 2 phase 3 trials, according to topline results announced by Novartis. The company said REMODEL-1 and REMODEL-2 each met its primary endpoint, although numerical efficacy estimates were not included in the release.

The identical multicenter, randomized, double-blind, active comparator-controlled trials enrolled approximately 2,000 adults worldwide with evidence of recent disease activity and Expanded Disability Status Scale scores ranging from 0.0 to 5.5. Participants were randomly assigned 1:1 to remibrutinib 100mg or teriflunomide. The double-blind core period had a flexible duration of up to 30 months, followed by an open-label extension planned for up to 5 years.

Novartis reported that remibrutinib was superior to teriflunomide on all key secondary endpoints assessed within each trial, including measures of inflammatory brain lesions on MRI. In a prespecified combined analysis of the 2 studies, remibrutinib showed a positive trend for 3-month confirmed disability progression and a nominally significant result for 6-month confirmed disability progression.

The company described the safety profile as favorable and consistent with the broader remibrutinib development program, which has included more than 4,500 clinical trial participants across multiple indications. Novartis reported no liver safety signal and no cases meeting Hy’s Law criteria. Detailed adverse-event and treatment-discontinuation rates were not provided.

Remibrutinib is an oral Bruton’s tyrosine kinase inhibitor that remains investigational for RMS. Novartis plans to present detailed REMODEL data at MSToronto2026 and seek regulatory approval for the RMS indication globally. No regulatory application or approval for RMS was announced in the release.

Source: Novartis. Novartis remibrutinib, a high-efficacy oral BTK inhibitor, significantly reduces relapse rates and shows favorable safety profile in phase III RMS trials. Press release. Novartis; September 1, 2026. Accessed September 2, 2026.