FAQs about tolebrutinib in MS
Tolebrutinib is an experimental therapy that is designed to block the activity of Bruton’s tyrosine kinase (BTK), a protein that is essential to the inflammatory activity of certain immune cells involved in multiple sclerosis. This is expected to reduce the smoldering inflammation that contributes to the progression of disability.
The U.S. Food and Drug Administration (FDA) is currently reviewing tolebrutinib as a potential therapy for nonrelapsing secondary progressive multiple sclerosis (SPMS) and to slow disability accumulation independent of relapse activity in adults with multiple sclerosis. A decision is expected by Sept. 28, 2025.
Clinical trials of tolebrutinib have not included pregnant or breastfeeding patients and all trial participants with the capacity to reproduce were required to use effective contraception methods. It is unclear whether tolebrutinib can be safely taken during pregnancy.
Multiple sclerosis can manifest differently in each patient, so individual responses to treatment may vary. In a Phase 2 clinical trial, some early signs of tolebrutinib became evident after about three months, [from here] but it’s not known if this was confirmed in larger Phase 3 clinical trials.
Weight gain has not been reported as a side effect of tolebrutinib, but hair loss was observed in some patients who received the medication. Patients who experience unexpected effects of medications should consult their healthcare teams.
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