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Tolebrutinib

Learn how tolebrutinib is changing the multiple sclerosis (MS) landscape.

What is tolebrutinib and what sets it apart

Tolebrutinib is a potential first-in-class, brain-penetrant Bruton tyrosine kinase (BTK) inhibitor developed for MS. By crossing the blood-brain barrier, it achieves therapeutic exposure in the CNS, enabling direct modulation of B-lymphocytes and disease-associated microglia that drive smoldering neuroinflammation and therefore disability accumulation.

This novel mechanism distinguishes it from conventional MS therapies, which largely focus on peripheral inflammation. By addressing the core inflammatory processes underlying progressive MS, tolebrutinib could slow neurodegeneration, offering a transformative advance in treating a disease with high unmet need.

About tolebrutinib

  • Company: Sanofi
  • Type: BTK inhibitor
  • Usage: Once-daily oral administration to treat non-relapsing secondary progressive-MS (nrSP-MS)
  • When will tolebrutinib be available?
    Expected launch 2026: European Union, United States
    Expected launch 2027: Japan

Tolebrutinib sales and success forecasts

$1.4bn
expected sales in the G7 markets in 2031
95%
probability of success for tolebrutinib in the United States

You basically have a drug that shows effectiveness in a cohort that is harder to treat, and you have a drug that shows equal effectiveness to teriflunomide, which is a standard first-line level agent.

Neurologist United States

Drugs in the 2026 list

Navigating Complete Response Letters: how Clarivate solutions can help pharmas chart their path to approval Navigating Complete Response Letters: how Clarivate solutions can help pharmas chart their path to approval
Blog February 24, 2026
Navigating Complete Response Letters: how Clarivate solutions can help pharmas chart their path to approval

When a drug’s path to market is complicated by an unanticipated regulatory action, pharmaceutical companies face a critical juncture: respond effectively and quickly, or watch development timelines—and competitive advantage—slip away….

Tolebrutinib: when safety concerns override efficacy signals Tolebrutinib: when safety concerns override efficacy signals
Blog February 24, 2026
Tolebrutinib: when safety concerns override efficacy signals

This blog post is the second in our series about the Complete Response Letters (CRLs) that the U.S. Food and Drug Administration (FDA) issued to Sanofi for tolebrutinib to treat…

Relacorilant:  when evidence meets the established evidence bar Relacorilant:  when evidence meets the established evidence bar
Blog February 24, 2026
Relacorilant: when evidence meets the established evidence bar

This blog post is the third in our series about the Complete Response Letters (CRLs) that the U.S. Food and Drug Administration (FDA) issued to Sanofi for tolebrutinib to treat…

The path forward: What comes after a CRL? The path forward: What comes after a CRL?
Blog February 24, 2026
The path forward: What comes after a CRL?

This blog post is the last in our series about the Complete Response Letters (CRLs) that the U.S. Food and Drug Administration (FDA) issued to Sanofi for tolebrutinib to treat…

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