Tolebrutinib FDA Approval Status
Last updated by Judith Stewart, BPharm on April 10, 2025.
FDA Approved: No
Generic name: tolebrutinib
Company: Sanofi
Treatment for: Multiple Sclerosis
Tolebrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor in development for the treatment of non-relapsing secondary progressive multiple sclerosis.
- Multiple sclerosis (MS) is a chronic, immune-mediated, neurodegenerative disease that leads to the accumulation of irreversible disabilities over time. Non-relapsing secondary progressive multiple sclerosis (nrSPMS) refers to people with MS who have stopped experiencing relapses but continue to accumulate disability. Symptoms include fatigue, cognitive impairment, balance and gait impairment, loss of bowel and/or bladder function, and sexual disfunction.
- Tolebrutinib is a brain-penetrant BTK inhibitor specifically designed to target smoldering neuroinflammation, a key driver of disability progression in MS.
- Tolebrutinib was granted breakthrough therapy designation by the FDA based on positive results from the HERCULES phase 3 study in adults with nrSPMS.
- The U.S. Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat nrSPMS and to slow disability accumulation independent of relapse activity in adult patients. The target action date for the FDA decision is September 28, 2025.
Development timeline for tolebrutinib
Further information
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