Tolebrutinib belongs to the class of Bruton tyrosine kinase inhibitors. Recently, negative news weakened hope for the BTKi, particularly among people with progressive multiple sclerosis. Professor Mathias Mäurer summarizes new information on Tolebrutinib in the interview.
In mid-December 2025, the manufacturer announced that Tolebrutinib had failed to meet its primary study objective against primary progressive multiple sclerosis (PPMS). Therefore, they withdrew the approval application for Tolebrutinib for this patient group or indication. Less than ten days later, there was even worse news: The FDA (Food and Drug Administration of the USA) also rejected the approval application for Tolebrutinib for secondary progressive MS (SPMS).
- What all this means,
- why the US drug agency rejected the approval application despite positive Phase 3 results in SPMS,
- how side effects on the liver should be classified,
- whether, when and under what conditions Tolebrutinib might still come to market, and
- when this could happen in Europe and Germany –
Professor Mathias Mäurer, Chief Physician of Neurology at the Würzburg-Mitte Hospital and author of MS-Docblog, discusses these topics in this interview. He also explains the principle of action of the Bruton tyrosine kinase inhibitors in MS.
This post was translated from German to English with the help of AI.
