Last reviewed · How we verify
Placebo matching fingolimod
Fingolimod is a sphingosine-1-phosphate receptor modulator that reduces lymphocyte egress from lymphoid tissues, decreasing their infiltration into the central nervous system.
Fingolimod is a sphingosine-1-phosphate receptor modulator that reduces lymphocyte egress from lymphoid tissues, decreasing their infiltration into the central nervous system. Used for Relapsing-remitting multiple sclerosis, Secondary progressive multiple sclerosis.
At a glance
| Generic name | Placebo matching fingolimod |
|---|---|
| Sponsor | Biogen |
| Drug class | Sphingosine-1-phosphate receptor modulator |
| Target | S1P1, S1P3, S1P4, S1P5 (sphingosine-1-phosphate receptors) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Fingolimod binds to sphingosine-1-phosphate receptors (S1P1, S1P3, S1P4, S1P5) on lymphocytes and vascular endothelial cells. This binding causes internalization and degradation of the S1P1 receptor, preventing lymphocyte exit from secondary lymphoid organs and reducing their migration to inflamed tissues in the CNS. This mechanism reduces the autoimmune attack on myelin in multiple sclerosis.
Approved indications
- Relapsing-remitting multiple sclerosis
- Secondary progressive multiple sclerosis
Common side effects
- Headache
- Liver enzyme elevation
- Bradycardia (on initiation)
- Macular edema
- Infections
- Hypertension
Key clinical trials
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS) (PHASE3)
- Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis (PHASE3)
- A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS) (PHASE3)
- Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis (PHASE3)
- Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients. (PHASE3)
- This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS. (PHASE3)
- Safety and Efficacy of Fingolimod in MS Patients in China (PHASE3)
- Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo matching fingolimod CI brief — competitive landscape report
- Placebo matching fingolimod updates RSS · CI watch RSS
- Biogen portfolio CI