Tolebrutinib
How it works: Reaching inflammation inside the brain →
Cenrifki
EU: Approved in the EU since 2026US: Not FDA approved
- Molecule type
- Small molecule
- Mechanism (ChEMBL)
- Tyrosine-protein kinase BTK inhibitor
- Targets
- Tyrosine-protein kinase BTK
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
- EU/EEACenrifki · Authorised19 June 2026 Source
Safety communications
None recorded.
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
2 reports in total, 2 marked serious.
- Multiple sclerosis relapse2
- Anhedonia1
- Apathy1
- Central nervous system lesion1
- Contusion1
- Decreased appetite1
- Depression1
- Disorientation1
- Dysaesthesia1
- Fatigue1
Trials
Key trials
Large trials with a reported result on their main goal.
- Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study o
Completed · Phase 3 · Progressive MS · Met its main goal
- Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine
Completed · Phase 3 · Relapsing MS · Missed its main goal
- Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine
Completed · Phase 3 · Relapsing MS · Missed its main goal
Running now
- A Study to Describe Multiple Sclerosis Patients Treated With Tolebruti
Recruiting · MS (type not specified) · Still running
- A Randomized Open Label Trial Exploring the Soluble and Imaging Biomar
Not yet recruiting · Phase 3 · MS (type not specified) · Still running
- A study to investigate long-term safety and tolerability of tolebrutin
Running, not recruiting · Phase 3 · Relapsing and progressive · Still running
- A Study to Investigate Long-term Safety and Tolerability of Tolebrutin
Running, not recruiting · Phase 3 · Relapsing and progressive · Still running
Other trials (7)
Completed small trials, dose-finding studies and trials in other diseases.
- Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, fo
Status unknown · Phase 2 · MS (type not specified) · Results posted, not judged
- Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosi
Completed · Phase 3 · Progressive MS · Paper found, not read
- Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442
Completed · Phase 1 · MS (type not specified) · No results found
- Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifam
Completed · Phase 1 · MS (type not specified) · No results found
- Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in
Completed · Phase 1 · MS (type not specified) · No results found
- Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Par
Completed · Phase 2 · Relapsing MS · Results posted, not judged
- Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis
Completed · Phase 2 · Relapsing MS · Met its main goal
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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