ZEPOSIA (ozanimod hydrochloride)
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-03-25
- Patent Cliff
- 2038
- Revenue
- $157M (Q4-2025)
- 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
ZEPOSIA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZEPOSIA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZEPOSIA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZEPOSIA
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
Indications & Usage
FDA Label (PDF)ZEPOSIA is indicated for the treatment of Relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease); Moderately to severely active ulcerative colitis.
ZEPOSIA Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ZEPOSIA
Revenue Insights
- • Q4-2025: $157M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 54 active patents
Trial Analysis
- • 28 total trials
- • Stage: Declining
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment