Back to News
Dec 15, 2025 8:00 AM

Sanofi's Multiple Sclerosis Drug Faces Trial And Regulatory Setbacks

On Monday, Sanofi SA (NASDAQ:SNY) announced results from the PERSEUS phase 3 study of tolebrutinib compared to placebo for primary progressive multiple sclerosis (PPMS).

Multiple sclerosis is an autoimmune disease resulting in damage to myelin, which is the insulating cover of nerve cells in the brain and spinal cord.

PPMS is a less common, severe form of MS where neurological function steadily worsens from the start, without distinct relapses or remissions, causing gradual disability, especially mobility issues.

Also Read: Sanofi Scores Two Major China Approvals For Rare Blood Disorder Drugs

Participants were randomized (2:1) to receive either an oral daily dose of tolebrutinib or a matching placebo for up to approximately 60 months.

The trial did not meet its primary endpoint in delaying time to 6-month composite confirmed disability ...