ZEPOSIA
ZEPOSIA (ozanimod hydrochloride) is a sphingosine 1-phosphate receptor modulator indicated for use in adult patients. It is approved for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The medication is also used to treat adults with moderately to severely active ulcerative colitis.
How ZEPOSIA Works
Ozanimod binds with high affinity to sphingosine 1-phosphate (S1P) receptors 1 and 5. This action blocks the capacity of lymphocytes to egress from lymph nodes, which reduces the total number of lymphocytes circulating in the peripheral blood. The therapeutic effect in multiple sclerosis and ulcerative colitis may involve the reduction of lymphocyte migration into the central nervous system and the intestine.
Details
- Status
- Prescription
- First Approved
- 2020-03-25
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ZEPOSIA Approval History
What ZEPOSIA Treats
2 indicationsZEPOSIA is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease)
- Moderately to severely active ulcerative colitis
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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.
ZEPOSIA FDA Label Details
ProIndications & Usage
FDA Label (PDF)ZEPOSIA 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 adults. • moderately to severely active ulcerative colitis (UC) in adults. ZEPOSIA 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 adults. • Moderately to severely active ulcerative colitis (UC) in adult...
ZEPOSIA Patents & Exclusivity
Patents (54 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.