Novartis has reported that its oral Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, met its primary endpoint in two Phase III trials, REMODEL-1 and REMODEL-2, for adults with relapsing multiple sclerosis (RMS).
In the multicentre, double-blind studies, remibrutinib showed a statistically significant reduction in annualised relapse rate compared to teriflunomide.
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Both trials also showed remibrutinib was superior across key secondary endpoints, including reductions in magnetic resonance imaging (MRI) lesions.
The preplanned combined analysis of the trials indicated a positive trend in three-month confirmed disability progression (3mCDP) and a nominally statistically significant result for six-month confirmed disability progression (6mCDP).
Novartis reported that remibrutinib’s safety profile in these RMS trials was consistent with earlier studies, including its development in chronic spontaneous urticaria, with no liver safety signal identified and no cases meeting Hy’s Law criteria.
Novartis development president and chief medical officer Shreeram Aradhye said: “Despite advances in treatment, an unmet need remains for oral therapies that can deliver robust relapse prevention and slow disability progression while maintaining a favourable safety profile.
“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.”
Nearly 2,000 patients in countries worldwide participated in the REMODEL-1 and REMODEL-2 studies.
Participants with an Expanded Disability Status Scale of 0.0–5.5 were randomised to receive either remibrutinib or teriflunomide.
In addition to the primary endpoint of annualised relapse rate, the trials measured outcomes such as 3mCDP and 6mCDP, as well as several new or enlarging MRI lesions.
Novartis plans to present late-breaking data from the REMODEL trials at MSToronto2026 and intends to seek regulatory submissions for remibrutinib in RMS across multiple regions.
Remibrutinib is also being investigated in other neurological and immune-mediated conditions. It is already approved under the name Rhapsido for chronic spontaneous urticaria by health authorities in the US and EU.
In June 2026, Novartis announced final results from the Phase III ALIGN study, highlighting that Vanrafia (atrasentan) slowed kidney function decline versus placebo in adults with IgA nephropathy.
