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Fingolimod 0.5mg
Fingolimod 0.5mg, marketed by Novartis Pharmaceuticals, is a well-established treatment in the multiple sclerosis market. The drug's key strength lies in its unique mechanism of action, which differentiates it from other therapies. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | Fingolimod 0.5mg |
|---|---|
| Also known as | FTY720 |
| Sponsor | Novartis Pharmaceuticals |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients (PHASE4)
- Fingolimod for Type 2 Diabetes Mellitus (PHASE4)
- Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage (PHASE1, PHASE2)
- A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod (PHASE4)
- Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks (PHASE4)
- Fingolimod in Schizophrenia Patients (PHASE2)
- Efficacy and Safety of FTY720 for Acute Stroke (PHASE2)
- 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)
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:
- Fingolimod 0.5mg CI brief — competitive landscape report
- Fingolimod 0.5mg updates RSS · CI watch RSS
- Novartis Pharmaceuticals portfolio CI