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An oral BTK inhibitor cuts MS relapse rates in two Phase III trials

An immunostained section of brain tissue under the microscope, where dense brown-stained immune cells crowd the left of the frame and thin out across a paler region to the right.

Marvin 101, via Wikimedia Commons (CC BY-SA 3.0)CC BY-SA

Novartis reported topline results on 1 September 2026 from REMODEL-1 and REMODEL-2, two Phase III trials of the oral BTK inhibitor remibrutinib in relapsing multiple sclerosis, enrolling roughly 2,000 patients between them against the comparator teriflunomide.

Both trials met their primary endpoint, reducing the annualized relapse rate against teriflunomide, and the company reports superiority on all key secondary endpoints within each trial, including reduction of MRI lesions. On disability, a combined analysis of the two trials showed a positive trend on three-month confirmed disability progression and a nominally significant result at six months. Novartis states there is no liver safety signal and no cases meeting the criteria of Hy’s Law, which matters because hepatotoxicity has dogged this drug class.

The release carries no numbers. Percentages, hazard ratios and confidence intervals are all absent, and the company says late-breaking data will be presented at MSToronto2026, with regulatory submissions planned globally. Until then the claim of superiority cannot be weighed against the existing high-efficacy options.

Remibrutinib is already on the market under the name Rhapsido, approved by the FDA in September 2025 and the EMA in April 2026, for chronic spontaneous urticaria.

Sources

  1. [1]Novartis remibrutinib, a high-efficacy oral BTK inhibitor, significantly reduces relapse rates and shows favorable safety profile in Phase III RMS trialsNovartis··Press release