Roche's fenebrutinib shows promise in reducing disability progression in primary progressive multiple sclerosis

Late-breaking Phase III FENtrepid results presented at ACTRIMS demonstrate investigational fenebrutinib met its primary endpoint of non-inferiority compared to OCREVUS

Feb. 7, 2026 at 9:31pm

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Roche announced new late-breaking data from the Phase III FENtrepid study showing the investigational Bruton's tyrosine kinase (BTK) inhibitor fenebrutinib met its primary endpoint of non-inferiority compared to OCREVUS in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS). Fenebrutinib showed a 12% reduction in the risk of disability progression compared to OCREVUS, the only approved medicine for PPMS, as measured by the time to onset of 12-week composite confirmed disability progression. The strongest treatment effect was observed on the risk of worsening upper limb function by 26% compared to OCREVUS.

Why it matters

With only one disease-modifying therapy available for people with PPMS, fenebrutinib has the potential to be a high-efficacy, oral treatment option that acts directly in the brain, targeting progressive biology, and may slow disability progression. This represents the first potential scientific breakthrough for the PPMS community in over a decade.

The details

The FENtrepid study is a Phase III multicentre, randomised, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of fenebrutinib compared with OCREVUS in 985 adult patients with PPMS. The primary endpoint is the time to onset of 12-week composite confirmed disability progression, which incorporates measures of total functional disability, walking speed, and upper limb function. Fenebrutinib numerically reduced the risk of disability progression by 12% compared to OCREVUS, with the strongest effect observed on upper limb function. Adverse events were generally comparable between the two treatment groups.

  • The FENtrepid study results were presented at the ACTRIMS Forum 2026 in San Diego, California.

The players

Roche

A Swiss multinational healthcare company and the world's largest biotechnology company.

Fenebrutinib

An investigational oral, central nervous system-penetrant, reversible and non-covalent Bruton's tyrosine kinase (BTK) inhibitor being developed by Roche for the treatment of multiple sclerosis.

OCREVUS

The only approved treatment for primary progressive multiple sclerosis (PPMS).

Amit Bar-Or

Professor and Director of the Center for Neuroinflammation and Neurotherapeutics at the Perelman School of Medicine, University of Pennsylvania.

Levi Garraway

Chief Medical Officer and Head of Global Product Development at Roche.

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What they’re saying

“Fenebrutinib showed a consistent clinical benefit as early as week 24, notably in upper limb function, which is essential for preserving independence and daily functioning.”

— Amit Bar-Or, Professor and Director of the Center for Neuroinflammation and Neurotherapeutics, Perelman School of Medicine, University of Pennsylvania

“Fenebrutinib represents the first potential scientific breakthrough for the PPMS community in over a decade, demonstrating a meaningful clinical benefit in reducing disability progression in a study versus the only approved treatment in PPMS.”

— Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche

What’s next

Once the second relapsing multiple sclerosis (RMS) study (FENhance 1) has read out, which is expected in the first half of 2026, data from all Phase III fenebrutinib trials will be submitted to regulatory authorities.

The takeaway

The positive results from the FENtrepid study suggest fenebrutinib could become the first new treatment option for primary progressive multiple sclerosis in over a decade, providing a much-needed oral therapy that targets progressive disease biology and may help slow disability progression, particularly in upper limb function.