GILENYA
Gilenya (fingolimod hydrochloride) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis. The medication is approved for use in adult and pediatric patients aged 10 years and older. It serves as a therapeutic option for managing clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
How GILENYA Works
Fingolimod is metabolized into its active form, fingolimod-phosphate, which binds to sphingosine 1-phosphate receptors 1, 3, 4, and 5. This process blocks lymphocytes from exiting the lymph nodes, effectively reducing the number of these cells circulating in the peripheral blood. The drug's therapeutic effect in multiple sclerosis is thought to result from this reduction in lymphocyte migration into the central nervous system.
Details
- Status
- Prescription
- First Approved
- 2010-09-21
- Routes
- ORAL
- Dosage Forms
- CAPSULE
GILENYA Approval History
What GILENYA Treats
3 indicationsGILENYA is approved for 3 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GILENYA FDA Label Details
ProIndications & Usage
FDA Label (PDF)GILENYA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.