PONVORY (ponesimod)
PONVORY is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.
How PONVORY Works
Ponesimod functions as a sphingosine 1-phosphate (S1P) receptor 1 modulator that binds with high affinity to its target receptor. This binding action blocks the capacity of lymphocytes to egress from the lymph nodes, which reduces the total number of lymphocytes circulating in the peripheral blood. While the exact mechanism is unknown, the drug's therapeutic effect in MS may involve the reduction of lymphocyte migration into the central nervous system.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-03-18
- Patent Cliff
- 2042
- Routes
- ORAL
- Dosage Forms
- TABLET
PONVORY Approval History
What PONVORY Treats
3 indicationsPONVORY is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
PONVORY 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 PONVORY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PONVORY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PONVORY
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07362017 | VP-VSP-128-3102 | Ph 3 | not yet recruiting | Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis |
| NCT03232073 OPTIMUM-LT results posted | AC-058B303 AC-058B303, 2016-004719-10 | Ph 3 | completed | Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis |
| NCT05552196 | CR109254 2022-000502-97, 67896153MSC1001 | Ph 1 | completed | A Study of Ponesimod in Healthy Adult Participants |
| NCT02425644 OPTIMUM results posted | AC-058B301 2012-000540-10 | Ph 3 | completed | Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis |
| NCT02461134 results posted | AC-058C202 | Ph 2 | terminated | Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD |
| NCT02907177 POINT results posted | AC-058B302 | Ph 3 | terminated | Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) |
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.
PONVORY FDA Label Details
Indications & Usage
FDA Label (PDF)PONVORY is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.
PONVORY Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for PONVORY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 500 active patents
Trial Analysis
- • 6 total trials
- • Stage: Declining
Competitive Landscape
- • 13 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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