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FTY720
Fingolimod (FTY720/Gilenya) is Novartis's marketed sphingosine-1-phosphate receptor modulator for relapsing forms of multiple sclerosis. The drug reduces clinical exacerbations and delays disability progression by sequestering lymphocytes in lymph nodes, preventing autoimmune attack on the central nervous system. With 100 clinical trials and 2,047 publications, fingolimod represents a significant advancement in MS treatment, reducing relapse rates by approximately 50% over two years. As a first-in-class oral immunomodulator, it established a new therapeutic paradigm for MS management and maintains strong commercial relevance in the competitive MS market.
At a glance
| Generic name | FTY720 |
|---|---|
| Also known as | 0.5 mg gelatin capsules |
| Sponsor | Novartis Pharmaceuticals |
| Drug class | Sphingosine-1-phosphate receptor modulator; Immunomodulator |
| Target | Sphingosine-1-phosphate receptors (S1P1, S1P3, S1P4, S1P5) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- Treatment of relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Common side effects
Drug interactions
- CYP450 inhibitors
- CYP450 inducers
- Live vaccines
- Anticoagulants
- Immunosuppressants
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)
- Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis (PHASE4)
- Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (PHASE2, PHASE3)
- Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis (PHASE3)
- Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis (NA)
- Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting 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)
- Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients (PHASE4)
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:
- FTY720 CI brief — competitive landscape report
- FTY720 updates RSS · CI watch RSS
- Novartis Pharmaceuticals portfolio CI