# Novartis remibrutinib Phase III clinical trial results

> Live situation record from CLSTR: https://clstr.news/situations/novartis-remibrutinib-phase-iii-clinical-trial-results
> Updated: 2026-09-03T23:30:08.000Z. Sources: 14. Developments: 2.

Novartis has reported positive topline results from two Phase III clinical trials, REMODEL-1 and REMODEL-2, evaluating its experimental oral drug remibrutinib for the treatment of relapsing multiple sclerosis. The drug, a Bruton’s tyrosine kinase (BTK) inhibitor, met its primary endpoint by significantly reducing annualized relapse rates compared to the active comparator, teriflunomide.

In addition to reducing relapses, the trials demonstrated superiority in secondary endpoints, including a reduction in MRI-detected inflammatory brain lesions and trends regarding disability progression. Novartis reported a favorable safety profile, noting that the drug showed no apparent liver safety signals, a concern that has impacted other drugs in the BTK inhibitor class.

Following the announcement, Novartis shares reached an all-time high. The company intends to seek global regulatory approval and plans to present full data during a presentation in October.

## Timeline

### 2026-09-03: Novartis reports positive Phase III results for oral MS drug remibrutinib

Novartis reported that its oral drug remibrutinib significantly reduced relapse rates and brain lesions in Phase III multiple sclerosis trials compared to teriflunomide, with no observed liver safety signals.

3 sources. https://clstr.news/cluster/novartis-reports-positive-phase-iii-results-for-oral-ms-drug-remibrutinib

### 2026-09-01: Novartis remibrutinib shows positive Phase III results for multiple sclerosis

Novartis reported positive Phase III results for remibrutinib, an oral drug for relapsing multiple sclerosis, which significantly reduced relapse rates and MRI lesions compared to teriflunomide.

11 sources. https://clstr.news/cluster/novartis-reports-positive-phase-iii-results-for-multiple-sclerosis-drug-remibrutinib

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Cite as: Novartis remibrutinib Phase III clinical trial results. CLSTR, https://clstr.news/situations/novartis-remibrutinib-phase-iii-clinical-trial-results
