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Data updated: Mar 10, 2026

PONVORY

PONESIMOD Sphingosine 1-Phosphate Receptor Modulators
Neurology Approved 2021-03-18

Ponvory (ponesimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. The medication is used to manage various stages of the disease, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It serves as a therapeutic option for adult patients requiring treatment for these specific relapsing forms of MS.

Source: FDA Label • VANDA PHARMS INC • Sphingosine 1-phosphate Receptor Modulator

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.

Source: FDA Label
1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2021-03-18
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: PONESIMOD

PONVORY Approval History

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What PONVORY Treats

3 indications

PONVORY 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
Source: FDA Label

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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

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Indications & Usage

FDA Label (PDF)

PONVORY 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. PONVORY 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.

PONVORY Patents & Exclusivity

Latest Patent: Oct 2042
Exclusivity: Mar 2026

Patents (500 active)

US11951097 Expires Oct 10, 2042
US12336980 Expires Dec 10, 2035
US10220023 Expires Dec 10, 2035
US9062014 Expires May 6, 2032
USRE43728 Expires Nov 16, 2029
+ 490 more patents

Exclusivity

NCE Until Mar 2026
NCE Until Mar 2026
NCE Until Mar 2026
NCE Until Mar 2026
NCE Until Mar 2026
Source: FDA Orange Book

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.