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.
8,920 reports in total, 4,480 marked serious.
- Fatigue1,002
- Headache892
- Dizziness674
- Multiple sclerosis relapse548
- Gait disturbance539
- Fall519
- Multiple sclerosis489
- Nausea424
- Drug ineffective422
- Lymphocyte count decreased421
Trials
Key trials
Large trials with a reported result on their main goal.
- Exploring the Efficacy and Safety of Siponimod in Patients With Second
Completed · Phase 3 · Relapsing and progressive · Met its main goal
Running now
- Exploring the effect of a novel therapy on chronic intrathecal inflamm
Recruiting · Phase 4 · Progressive MS · Still running
- Effect of siponimod on relevant imaging and immunological hallmarks of
Recruiting · Phase 4 · Progressive MS · Still running
- Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod
Running, not recruiting · Phase 3 · Relapsing MS · Still running
- A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY
Running, not recruiting · Relapsing MS · Still running
- Efficacy and safety of ofatumumab and siponimod compared to fingolimod
Ongoing · Phase 3 · MS (type not specified)
Other trials (9)
Completed small trials, dose-finding studies and trials in other diseases.
- Exploring the effect of a novel therapy on chronic intrathecal inflamm
Moved to EU CTIS registry · Phase 4 · Progressive MS
- Study to Assess the Efficacy of Mayzent on Microglia in Secondary Prog
Terminated · Phase 2 / Phase 3 · Progressive MS · Stopped
- Effect of siponimod on progressive multiple sclerosis
Moved to EU CTIS registry · Phase 4 · Progressive MS
- Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patient
Completed · Phase 4 · Relapsing and progressive · Results posted, not judged
- Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Pa
Completed · Progressive MS · No results found
- Safety and Tolerability of Conversion From Oral, Injectable, or Infusi
Completed · Phase 3 · Relapsing MS · Results posted, not judged
- Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in
Completed · Phase 2 · Relapsing MS · Main goal was not benefit
- Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF31
Completed · Phase 2 · Relapsing MS · Met its main goal
- Managed Access Program (MAP) for Patients Diagnosed With Secondary Pro
No longer available · Relapsing and progressive · No results 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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