- Novartis said two Phase 3 REMODEL trials of remibrutinib met their primary endpoint, reducing the annualized relapse rate versus teriflunomide in relapsing multiple sclerosis.
- The company said remibrutinib was superior to teriflunomide on all key secondary endpoints in each trial, including MRI lesion measures.
- Novartis plans to seek regulatory approval for remibrutinib in relapsing MS globally and will present the data as a late-breaker at MSToronto2026.
BASEL, Switzerland — Novartis AG said two Phase 3 trials of remibrutinib in relapsing multiple sclerosis met their primary endpoint, reducing the annualized relapse rate compared with teriflunomide.
The Swiss pharmaceutical company said in an emailed press release today that remibrutinib, an oral Bruton’s tyrosine kinase inhibitor, also showed superiority versus teriflunomide on all key secondary endpoints within each trial, including a reduction in inflammatory brain lesions.
The company did not disclose the size of the relapse-rate reduction. The results were released as an ad hoc announcement under Swiss listing rules.
Disability and Safety Findings
Novartis said a preplanned combined analysis of REMODEL-1 and REMODEL-2 showed a clinically meaningful delay in disability progression. That analysis found a positive trend on three-month confirmed disability progression and nominal statistical significance on six-month confirmed disability progression, the company said.
The safety profile was consistent with remibrutinib’s broader development program of more than 4,500 clinical-trial participants across several indications, Novartis said. The company said the drug was well tolerated and showed no liver safety signal, including no cases meeting Hy’s Law criteria.
Shreeram Aradhye, Novartis president of development and chief medical officer, said the REMODEL results “underscore the potential of remibrutinib as a high-efficacy oral therapy for people living with RMS with a differentiated benefit-risk profile.”
Trial Design and Next Steps
REMODEL-1 and REMODEL-2 are identical multicenter, randomized, double-blind, active-comparator Phase 3 studies. About 2,000 adults with relapsing MS, recent disease activity, and an Expanded Disability Status Scale score of 0.0 to 5.5 were randomized 1:1 to remibrutinib 100 mg or teriflunomide, Novartis said. The core double-blind period lasts up to 30 months, followed by an open-label extension of up to five years.
The primary endpoint is annualized relapse rate. Key secondary endpoints include three- and six-month confirmed disability progression, new or enlarging T2 lesions per year, gadolinium-enhancing T1 lesions per scan, serum neurofilament light chain concentration, and the share of participants with no evidence of disease activity (NEDA-3).
Novartis will present the REMODEL-1 and REMODEL-2 data as a late-breaker at MSToronto2026 and intends to hold an investor call after that presentation. The company plans to seek regulatory approval for remibrutinib in relapsing MS globally.
Remibrutinib 25 mg is already approved as Rhapsido in the United States and the European Union for adults with chronic spontaneous urticaria. It remains investigational for multiple sclerosis. Novartis is also studying the drug in secondary progressive MS and other immune-mediated conditions.
Novartis is a Swiss pharmaceutical company listed on the SIX Swiss Exchange and headquartered in Basel.