Novartis Reports Positive Phase III RMS Results for Remibrutinib

Novartis on September 1, 2026 announced positive topline results from its Phase III REMODEL-1 and REMODEL-2 trials of remibrutinib in relapsing multiple sclerosis, reporting that both studies met their primary endpoint by significantly reducing annualized relapse rate versus the active comparator teriflunomide. The company disclosed the findings in an ad hoc announcement issued pursuant to Article 53 of the SIX Swiss Exchange Listing Rules, the Swiss disclosure requirement for price-sensitive facts, and said it plans to submit remibrutinib in relapsing multiple sclerosis to health authorities globally.

According to Novartis, the trials showed superiority of remibrutinib over teriflunomide on all key secondary endpoints within each trial, including reduction of MRI lesions. In a preplanned combined analysis of REMODEL-1 and REMODEL-2, the company reported a clinically meaningful delay in disability progression, with a positive trend in 3-month confirmed disability progression and nominal significance in 6-month confirmed disability progression.

The safety profile in the REMODEL program was consistent with the broader remibrutinib development program, which comprises more than 4,500 clinical trial participants across multiple indications, Novartis stated. The company said remibrutinib was well tolerated and continued to demonstrate no liver safety signal, including no cases meeting Hy’s Law criteria.

“Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention, slow disability progression, while maintaining a favorable safety profile,” said Shreeram Aradhye, President, Development, and Chief Medical Officer, Novartis. “The positive REMODEL results underscore the potential of remibrutinib as a high-efficacy oral therapy for people living with RMS with a differentiated benefit-risk profile.”

REMODEL Trial Design

REMODEL-1 and REMODEL-2 are identical multicenter, randomized, double-blind, active comparator-controlled Phase III studies evaluating the efficacy and safety of remibrutinib compared to teriflunomide in adult patients with relapsing multiple sclerosis. Approximately 2,000 patients globally with evidence of recent disease activity and an Expanded Disability Status Scale score of 0.0 to 5.5 were randomized 1:1 to receive remibrutinib 100 mg or teriflunomide, according to the company. Each study consists of an initial double-blind Core Part with a flexible duration of up to a maximum of 30 months, followed by an open-label extension for up to 5 years.

The primary endpoint is annualized relapse rate. Key secondary endpoints include 3- and 6-month confirmed disability progression, the number of new or enlarging T2 lesions per year, the number of gadolinium-enhancing T1 lesions per scan, serum neurofilament light chain concentration, and the percentage of participants with no evidence of disease activity, measured as NEDA-3.

Registry records on ClinicalTrials.gov describe each Core Part as a randomized, double-blind, double-dummy, parallel-group comparison in which participants received either a remibrutinib tablet with matching teriflunomide placebo or a teriflunomide capsule with matching remibrutinib placebo. The REMODEL-1 record lists an actual start date of December 16, 2021, a primary completion date of July 21, 2026, actual enrollment of 1,000 participants, and an estimated overall completion date of October 30, 2030. The REMODEL-2 record lists an actual start date of December 13, 2021, a primary completion date of July 22, 2026, actual enrollment of 1,007 participants, and the same estimated completion date. Both trials are listed as active and no longer recruiting, with sites across North America, South America, Europe, Asia, Africa, and the Middle East, and each record notes that data from the two studies will be pooled for some endpoints. Eligible participants were 18 to 55 years of age with a diagnosis of relapsing multiple sclerosis under the 2017 McDonald diagnostic criteria.

Regulatory Plans and Remibrutinib Background

Novartis will present the REMODEL-1 and REMODEL-2 data as a late-breaker at MSToronto2026 and intends to host an investor call following the congress presentation. The company plans to seek regulatory approval for remibrutinib in relapsing multiple sclerosis globally.

Remibrutinib is a highly selective, oral Bruton’s tyrosine kinase inhibitor that blocks the BTK pathway, reducing activation of B cells and innate immune cells to modulate immune regulatory networks and related neuroinflammation. Discovered at Novartis, the compound is being investigated in neuroscience indications including the Phase III REMASTER trial in secondary progressive multiple sclerosis, as well as in other immune-mediated conditions such as hidradenitis suppurativa and food allergy.

Remibrutinib 25 mg is already approved as Rhapsido for adults with chronic spontaneous urticaria. The U.S. Food and Drug Administration approved Rhapsido in September 2025, and the European Commission approved it in April 2026. The FDA approval covered adult patients who remain symptomatic despite H1 antihistamine treatment and was based on the Phase III REMIX-1 and REMIX-2 trials, in which Rhapsido demonstrated superiority versus placebo in change from baseline in itch, hives, and weekly urticaria activity at Week 12, Novartis said in its approval announcement. The European Commission approval covered adult patients with inadequate response to H1-antihistamine treatment, following a positive opinion from the Committee for Medicinal Products for Human Use in February 2026.

Multiple sclerosis is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage in the brain, optic nerves, and spinal cord, and it affects nearly 3 million people worldwide, according to Novartis. Relapsing multiple sclerosis is the most common form of the disease and includes clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.