A major step forward in the treatment of Multiple sclerosis (MS) has been reported with the Phase 3 HERCULES study of the oral brain-penetrant inhibitor Tolebrutinib. In people living with non-relapsing secondary progressive MS (nrSPMS) — a form for which no therapies had been approved — the drug significantly delayed the progression of disability. The results were published April 8 2025 in the The New England Journal of Medicine. Source
The mechanism of action targets immune drivers of chronic inflammation behind the blood–brain barrier, rather than focusing on relapse activity. This differentiates tolebrutinib from many existing therapies and raises hope for progressive forms of MS.
For patients and neurologists, the implication is that earlier detection of progression and initiation of therapies specifically designed for progressive disease may alter long-term outcomes. The approval prospects (under review in the US and EU) could introduce the first effective treatment for nrSPMS.
In short, tolebrutinib represents a paradigm shift in MS treatment—targeting disability progression independent of relapse and offering hope in a previously unmet area.
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