Tolebrutinib: First Approval
- 24-11-2025
- Multiple Sclerosis
- AdisInsight Report
- Author
- Hannah A. Blair
- Published in
- Drugs | Issue 1/2026
Abstract
Tolebrutinib (CENRIFKI®) is an orally available, brain-penetrant small molecule inhibitor of Bruton’s tyrosine kinase (BTK) being developed by Sanofi for the treatment of multiple sclerosis (MS). On 26 August 2025, tolebrutinib received its first approval in the United Arab Emirates (UAE) for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adults. The drug is under regulatory review in the USA and the EU. This article summarizes the milestones in the development of tolebrutinib leading to this first approval for MS.
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- Title
- Tolebrutinib: First Approval
- Author
-
Hannah A. Blair
- Publication date
- 24-11-2025
- Publisher
- Springer International Publishing
- Published in
-
Drugs / Issue 1/2026
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950 - DOI
- https://doi.org/10.1007/s40265-025-02264-z
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