Siponimod
How it works: Keeping immune cells out of the brain →
Mayzent
EU: Approved in the EU since 2020US: FDA approved 2019
- Molecule type
- Small molecule
- Mechanism (ChEMBL)
- Sphingosine 1-phosphate receptor Edg-1 agonist
- Targets
- Sphingosine 1-phosphate receptor 1
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
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.
8,870 reports in total, 4,439 marked serious.
- Fatigue993
- Headache890
- Dizziness671
- Multiple sclerosis relapse546
- Gait disturbance537
- Fall511
- Multiple sclerosis486
- Nausea423
- Drug ineffective417
- Lymphocyte count decreased417
Trials
Key trials
Large trials with a reported result on their main goal.
- Siponimod, phase 3
Completed · Phase 3 · Relapsing and progressive · Main goal met
Running now
- Siponimod, phase 4
Recruiting · Phase 4 · Progressive MS · ongoing
- SIPO20
Recruiting · Phase 4 · Progressive MS · ongoing
- NEOS
Running, not recruiting · Phase 3 · Relapsing MS · ongoing
- Alemtuzumab
Running, not recruiting · Relapsing MS · ongoing
- NEOS
Ongoing · Phase 3 · MS (type not specified)
Other trials (9)
Completed small trials, dose-finding studies and trials in other diseases.
- Siponimod, phase 4
Moved to EU CTIS registry · Phase 4 · Progressive MS
- Ocrelizumab, phase 2 / phase 3
Terminated · Phase 2 / Phase 3 · Progressive MS · stopped_other
- Siponimod, phase 4
Moved to EU CTIS registry · Phase 4 · Progressive MS
- AMA-VACC
Completed · Phase 4 · Relapsing and progressive · results_posted_no_test
- Siponimod
Completed · Progressive MS · no_result_found
- EXCHANGE
Completed · Phase 3 · Relapsing MS · results_posted_no_test
- Siponimod, phase 2
Completed · Phase 2 · Relapsing MS · Not an efficacy test
- Siponimod, phase 2
Completed · Phase 2 · Relapsing MS · Main goal met
- Siponimod
No longer available · Relapsing and progressive · no_result_found
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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