Novartis has announced positive topline results from its Phase 3 REMODEL-1 and REMODEL-2 trials of remibrutinib in relapsing multiple sclerosis.
Remibrutinib is a highly selective and potent oral Bruton’s tyrosine kinase inhibitor being developed to address significant unmet need in neurological conditions.
The trials were multicentre, double-blind studies that measured remibrutinib’s performance against teriflunomide across a range of clinical endpoints.
Remibrutinib demonstrated statistically significant superiority over teriflunomide in reducing annualized relapse rates and inflammatory brain lesions in both studies.
Both trials also showed the drug outperformed teriflunomide across key secondary endpoints, including meaningful reductions in MRI lesion activity.
A preplanned combined analysis of the two studies showed a positive trend in three-month confirmed disability progression and reached nominal significance for six-month confirmed disability progression versus teriflunomide.
Crucially for the drug’s commercial prospects, Novartis reported no liver safety signal and no cases meeting Hy’s Law criteria, a benchmark that has tripped up rival BTK inhibitors in development.
The clean safety profile is consistent with the broader remibrutinib programme, which now spans more than 4,500 participants across neurological and immune-mediated indications.
Nearly 2,000 patients in countries worldwide participated in the REMODEL-1 and REMODEL-2 studies, giving the dataset considerable statistical weight heading into regulatory discussions.
Novartis development president and chief medical officer Shreeram Aradhye said that despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention and slow disability progression while maintaining a favorable safety profile, adding that the positive REMODEL results underscore remibrutinib’s potential as a high-efficacy oral therapy for people living with relapsing multiple sclerosis.
Full results from the REMODEL programme are expected to be presented at MSToronto2026, the joint ECTRIMS-ACTRIMS meeting, scheduled for October 21 to 23 in Toronto, Canada.
Novartis plans to follow the conference presentation with an investor call, signalling the company views the data as commercially significant for its pipeline and near-term growth strategy.
The drug already has a commercial foothold under the brand name Rhapsido, having received FDA approval in September 2025 and European Medicines Agency approval in April 2026 for chronic spontaneous urticaria.
In that earlier indication, Phase 3 data showed reduced urticaria activity scores versus placebo with a tolerability profile described as similar to placebo, building confidence in the molecule’s safety credentials.
Novartis is also evaluating remibrutinib in REMASTER, a Phase 3 trial in nonrelapsing secondary progressive multiple sclerosis, as well as in hidradenitis suppurativa and peanut allergy.
The drug’s next commercial test will be whether the full REMODEL dataset can translate this headline Phase 3 victory into a durable position in the increasingly competitive oral BTK inhibitor market.