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 · Authorised2026-06-19 Source
Safety communications
None recorded.
Trials
Key trials
Large trials with a reported result on their main goal.
- HERCULES
Completed · Phase 3 · Progressive MS · Main goal met
- GEMINI 1
Completed · Phase 3 · Relapsing MS · Main goal not met
- GEMINI 2
Completed · Phase 3 · Relapsing MS · Main goal not met
Running now
- ORION
Recruiting · MS (type not specified) · ongoing
- MSBenefiT
Not yet recruiting · Phase 3 · MS (type not specified) · ongoing
- Tolebrutinib, phase 3
Running, not recruiting · Phase 3 · Relapsing and progressive · ongoing
- Tolebrutinib, phase 3
Running, not recruiting · Phase 3 · Relapsing and progressive · ongoing
Other trials (7)
Completed small trials, dose-finding studies and trials in other diseases.
- Tolebrutinib, phase 2
Status unknown · Phase 2 · MS (type not specified) · results_posted_no_test
- PERSEUS
Completed · Phase 3 · Progressive MS · result_in_paper_unread
- Tolebrutinib, phase 1
Completed · Phase 1 · MS (type not specified) · no_result_found
- Gemfibrozil, phase 1
Completed · Phase 1 · MS (type not specified) · no_result_found
- Tolebrutinib, phase 1
Completed · Phase 1 · MS (type not specified) · no_result_found
- Tolebrutinib, phase 2
Completed · Phase 2 · Relapsing MS · results_posted_no_test
- Tolebrutinib, phase 2
Completed · Phase 2 · Relapsing MS · Main goal met
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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