Cenrifki (tolebrutinib): EU-authorised treatment for a defined secondary progressive MS group

What is being studied

Tolebrutinib is an oral drug that blocks Bruton’s tyrosine kinase (BTK), an enzyme involved in immune-cell signalling. The Phase 3 HERCULES study compared it with placebo in people with secondary progressive MS without relapses. Cenrifki is the medicine name under which tolebrutinib is authorised in the EU for adults with secondary progressive MS who have had no relapses in the previous two years.

Research stage

Phase 3 study in people

EU-authorised for adults with SPMS without relapses in the previous two years; HERCULES completed

What we know so far

HERCULES randomised 1,131 people. Its peer-reviewed report found a lower risk of disability progression confirmed for at least six months with tolebrutinib than with placebo (hazard ratio 0.69; 95% confidence interval 0.55–0.88). The study is completed and results are posted in the official registry. The EMA identifies liver injury as the main safety concern; liver tests are required before and during treatment, and the medicine is under additional monitoring.

What this means for patients today

The EU marketing authorisation is real but applies only to the stated adult SPMS group. It does not by itself establish whether Cenrifki is commercially available or reimbursed in Greece. Treatment requires a prescription and supervision by a doctor experienced in MS; the liver precautions are part of the authorised use. This is not evidence that the medicine restores myelin or cures MS.