Remibrutinib trials reduced relapse rates compared with teriflunomide in two Phase 3 studies of relapsing multiple sclerosis, Novartis announced on October 23, 2026. The oral treatment also showed a signal of delayed disability progression and no observed liver safety signal. Novartis plans to seek regulatory approval globally for this use.
Key Takeaways
- Annualized relapse rates were 35.2% and 31.2% lower than with teriflunomide in the two trials.
- The pooled reduction in six-month confirmed disability progression reached nominal statistical significance.
- Novartis plans global regulatory applications; the results do not constitute approval for relapsing MS.
Table of Contents
- Remibrutinib trials meet the primary relapse endpoint
- Disability and MRI findings broaden the efficacy picture
- Liver findings favorable, but adverse events still occurred
- Regulatory applications remain the next planned step
- Conclusion
Remibrutinib trials meet the primary relapse endpoint
Novartis’s Phase 3 REMODEL results showed that both studies met their primary endpoint of reducing the annualized relapse rate. The company presented the findings at MSToronto2026, with simultaneous publication in The Lancet.
In REMODEL-1, annualized relapse rates were 0.073 with remibrutinib and 0.112 with teriflunomide, a relative reduction of 35.2%. In REMODEL-2, the respective rates were 0.080 and 0.116, a 31.2% reduction. Both comparisons were statistically significant.
The remibrutinib rates correspond to approximately one relapse every 13 years on an annualized basis. That is a way of expressing the observed relapse frequency, not evidence that patients were followed for 13 years or that each patient would experience that outcome.
| Item | Details |
|---|---|
| Trial design | Two identical multicenter, randomized, double-blind, active-comparator Phase 3 studies. |
| Enrollment | Approximately 2,000 adults globally, randomized 1:1. |
| Patient eligibility | Relapsing MS with recent disease activity and an Expanded Disability Status Scale score of 0.0–5.5. |
| Core study duration | Flexible double-blind period lasting up to 30 months. |
| Extension | Open-label extension lasting up to five years. |
Disability and MRI findings broaden the efficacy picture
In the pooled analysis, remibrutinib reduced the risk of six-month confirmed disability progression by 29.2% versus teriflunomide. Novartis described this result as nominally significant, a qualification that distinguishes it from the statistically significant primary relapse endpoints.
More than 92% of remibrutinib-treated patients remained free from progression over 24 months under that six-month confirmation measure. The three-month confirmed disability progression measure showed a positive trend, with a 20.5% risk reduction.
MRI findings also favored remibrutinib. Annualized T2 lesion activity was reduced by 65% and 70% in the two studies, while the rate of gadolinium-enhancing T1 lesions was reduced by 66% in both. These measures assess disease activity beyond relapses alone.
Liver findings favorable, but adverse events still occurred
Novartis reported no liver safety signal, including no Hy’s Law cases. Liver enzyme elevations above three times the upper limit of normal occurred in 2.0% of remibrutinib patients, compared with 7.4% receiving teriflunomide.
Treatment discontinuations because of adverse events were 3.1% with remibrutinib and 5.8% with teriflunomide. Serious adverse events occurred in 6.0% and 7.0%, respectively.
Two deaths occurred in the remibrutinib group: one from accidental carbon monoxide poisoning and one suicide. Investigators assessed both as unrelated to treatment. The absence of an observed liver signal does not mean the treatment was free of adverse events.
Regulatory applications remain the next planned step
Remibrutinib is an oral Bruton’s tyrosine kinase inhibitor designed to modulate immune signaling without chronic B-cell depletion. The REMODEL program tests it against an active treatment rather than placebo.
For Novartis, the findings support a potential additional use for a medicine already approved for certain urticaria conditions. Approval in those conditions does not establish approval for multiple sclerosis.
The company said it plans to seek regulatory approval for relapsing MS globally, but did not specify a submission timetable in the announcement. Clinical success therefore remains separate from regulatory authorization and future commercial performance.
Conclusion
The remibrutinib trials establish a relapse-control advantage over teriflunomide, alongside qualified disability findings and favorable liver observations. The next planned milestone is Novartis’s global regulatory applications for relapsing MS; no filing date was announced.
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