Basel, Switzerland, September 1, 2026
Novartis has announced positive topline results from the Phase III REMODEL-1 and REMODEL-2 trials, showing that remibrutinib, a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor, significantly reduced relapse rates in adults with relapsing multiple sclerosis (RMS) compared with teriflunomide. Both trials met their primary endpoint, demonstrating statistically significant reductions in annualized relapse rate (ARR). The studies also showed superiority across key secondary endpoints, including measures of inflammatory brain lesions, while a preplanned combined analysis indicated a clinically meaningful delay in disability progression. Novartis said the findings support the potential of remibrutinib as a high-efficacy oral treatment for people living with RMS.
REMODEL Trials Meet Primary Efficacy Endpoint
The identical multicenter, randomized, double-blind, active-comparator-controlled REMODEL-1 and REMODEL-2 Phase III studies evaluated remibrutinib against teriflunomide in adults with RMS who had evidence of recent disease activity. Approximately 2,000 participants worldwide were randomized to receive either remibrutinib 100 mg or teriflunomide. The primary endpoint was annualized relapse rate, with key secondary endpoints including 3-month and 6-month confirmed disability progression, new or enlarging T2 lesions, gadolinium-enhancing T1 lesions, serum neurofilament light chain concentrations and no evidence of disease activity. Both studies met their primary endpoint, with remibrutinib demonstrating superiority over teriflunomide in reducing relapses and inflammatory MRI lesions. The results are particularly relevant because multiple sclerosis is a chronic inflammatory disease of the central nervous system in which immune-mediated damage can affect the brain, optic nerves and spinal cord. RMS is the most common form of MS and is characterized by episodes of neurological worsening and disease activity. Although multiple treatment options are available, Novartis highlighted the continuing need for oral therapies that can provide strong relapse prevention while maintaining a favorable safety profile. The REMODEL findings therefore add potentially important Phase III evidence for an oral BTK inhibitor in this treatment landscape.
Remibrutinib Shows Disability and MRI Benefits
Beyond relapse reduction, remibrutinib produced encouraging findings on measures associated with disease progression and neuroinflammation. In the preplanned combined analysis of REMODEL-1 and REMODEL-2, treatment demonstrated a positive trend in 3-month confirmed disability progression (3mCDP) and nominal statistical significance for 6-month confirmed disability progression (6mCDP). The trials also showed superiority across key secondary endpoints related to MRI-detected inflammatory lesions. These findings suggest that the potential clinical benefit of remibrutinib may extend beyond reducing the frequency of acute relapses to influencing measures associated with longer-term disease activity. Remibrutinib works by selectively inhibiting the BTK pathway, which plays a role in the activation and signaling of B cells and innate immune cells. By modulating these immune pathways, the therapy is designed to influence inflammatory processes involved in neurological disease. Novartis discovered remibrutinib and is developing it across several immune-mediated and neurological conditions. The compound is also being evaluated in secondary progressive multiple sclerosis, hidradenitis suppurativa and food allergy.
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Favorable Safety Profile Supports Further Development
The safety results from REMODEL-1 and REMODEL-2 were described as favorable and consistent with the broader remibrutinib clinical development program, which includes more than 4,500 clinical trial participants across multiple indications. Importantly, Novartis reported no liver safety signal, including no cases meeting Hy’s Law criteria. The company said the safety findings were consistent with previous experience with remibrutinib in chronic spontaneous urticaria, where the medicine has already received regulatory approvals. Novartis plans to present detailed REMODEL-1 and REMODEL-2 data as a late-breaking presentation at MSToronto2026 and intends to seek regulatory approvals for remibrutinib in RMS globally. The company said the Phase III results reinforce the potential of remibrutinib to become a high-efficacy oral option for relapsing multiple sclerosis, subject to regulatory review. Further detailed data from the trials will help clarify the magnitude and durability of the treatment effect across relapse, MRI and disability-related outcomes as the development program advances.
Source: Novartis press release
