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<p>Tolebrutinib (CENRIFKI<sup>®</sup>) 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.</p>

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Tolebrutinib: First Approval

  • 期刊论文

  • 发表日期：

    2025年11月24日

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  • Hannah A. Blair

摘要

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.