FINGOLIMOD HYDROCHLORIDE
Fingolimod hydrochloride is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS). The medication is approved for use in patients 10 years of age and older. It is used to manage several manifestations of the condition, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
How FINGOLIMOD HYDROCHLORIDE Works
Fingolimod is metabolized into an active form that binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5. This interaction blocks lymphocytes from exiting the lymph nodes, which reduces the total number of lymphocytes circulating in the peripheral blood. While the exact therapeutic mechanism is unknown, the drug is thought to work by limiting the migration of these cells into the central nervous system.
Details
- Status
- Prescription
- First Approved
- 2019-12-04
- Routes
- ORAL
- Dosage Forms
- CAPSULE
FINGOLIMOD HYDROCHLORIDE Approval History
What FINGOLIMOD HYDROCHLORIDE Treats
1 indicationsFINGOLIMOD HYDROCHLORIDE is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
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Active Pipeline
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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.
FINGOLIMOD HYDROCHLORIDE FDA Label Details
ProIndications & Usage
Fingolimod capsules are 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. Fingolimod hydrochloride 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.