Rhapsido (Remibrutinib) - (REMODEL-1)

September 1, 2026: Novartis announced positive topline Phase III results for remibrutinib in relapsing multiple sclerosis from the REMODEL-1 and REMODEL-2 trials. In adults with RMS, remibrutinib was superior to teriflunomide on the primary endpoint, significantly reducing annualized relapse rate, and also showed superiority on all key secondary endpoints within each trial, including reductions in MRI lesions.

In a preplanned combined analysis of REMODEL-1/-2, remibrutinib showed a clinically meaningful delay in disability progression, with a positive trend in 3-month confirmed disability progression and nominally significant 6-month confirmed disability progression. Safety was described as favorable and consistent with the broader program, with no liver safety signal and no cases meeting Hy’s Law criteria.

The studies randomized approximately 2,000 patients globally 1:1 to remibrutinib 100 mg or teriflunomide. Novartis said it will present late-breaking REMODEL data at MSToronto2026 and plans to seek global regulatory approval for remibrutinib in RMS. The release also notes remibrutinib is being studied in Phase III REMASTER in secondary progressive MS.