Prescription medicine
Ponesimod Brand names: Ponvory
Ponesimod (Ponvory) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ponesimod FDA label on DailyMed (effective December 4, 2025, Vanda Pharmaceuticals Inc.); the NDA 213498 record on Drugs@FDA; every ponesimod label on DailyMed.
Highlights of the record
FDA label of December 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePONVORY 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.
Forms and strengths
- 20 mg
Kit; film-coated tablet.
On the market
- Earliest approval on file
- March 18, 2021 Ponvory, Vanda Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 10, 2042 Ponvory tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 428 through July 30, 2026
What is ponesimod used for?
From the label: indications and usagePONVORY 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.
Conditions named in the indications of ponesimod's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sphingosine 1-phosphate Receptor Modulator.
Source: FDA drug label (PONVORY), Vanda Pharmaceuticals Inc., effective December 4, 2025 (SPL set 0c025ba8-ba51-272e-e063-6294a90ad120), via openFDA; the full label on DailyMed
What does the patient leaflet for ponesimod say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about PONVORY?PONVORY may cause serious side effects, including: Infections. PONVORY can increase your risk of serious infections that can be life-threatening and cause death. PONVORY lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 1 to 2 weeks of stopping treatment. Your healthcare provider should review a recent blood test of your white blood cells before you start taking PONVORY. Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with PONVORY and for 1 to 2 weeks after your last dose of PONVORY: fever tiredness body aches chills nausea vomiting headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine) Your healthcare provider may delay starting or may stop your PONVORY treatment if you have an infection. Slow heart rate (bradycardia or bradyarrhythmia) when you start taking PONVORY. PONVORY can cause your heart rate to slow down, especially after you take your first dose. You should have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose of PONVORY. Only start your treatment with PONVORY using the Starter Pack. You must use the PONVORY Starter Pack to slowly increase the dose over a 14-day period to help reduce the effect of slowing of your heart rate. It is important to follow the recommended dosing instructions. […]
From the patient leaflet: How should I store PONVORY?Store PONVORY at room temperature between 68°F to 77°F (20°C to 25°C). Store PONVORY in the original package. The bottle of PONVORY contains a desiccant sachet to help keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant. Keep PONVORY and all medicines out of the reach of children.
Source: FDA drug label (PONVORY), Vanda Pharmaceuticals Inc., effective December 4, 2025 (SPL set 0c025ba8-ba51-272e-e063-6294a90ad120), via openFDA; the full label on DailyMed
Is there a generic for ponesimod (Ponvory)?
No generic ponesimod is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Ponvory tablets: the compound patent runs to May 6, 2032, and the last listed entry to October 10, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ponesimod label say about other medicines?
The ponesimod label names 10 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alemtuzumab | drug interactions | Because of the characteristics and duration of alemtuzumab immune suppressive effects, initiating treatment with PONVORY after alemtuzumab is not recommended. |
| Amiodarone | drug interactions | Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. |
| Digoxin | drug interactions | … calcium channel blockers (e.g., verapamil, diltiazem), or other drugs that may decrease heart rate (e.g., digoxin) [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.3 )]. |
| Diltiazem | drug interactions | … drugs with known arrhythmogenic properties, heart rate lowering calcium channel blockers (e.g., verapamil, diltiazem), or other drugs that may decrease heart rate (e.g., digoxin) [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.3 )]. |
| Glatiramer | drug interactions | PONVORY can generally be started immediately after discontinuation of beta interferon or glatiramer acetate. |
| Procainamide | drug interactions | Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. |
| Quinidine | drug interactions | Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. |
| Sotalol | drug interactions | Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. |
| Teriflunomide | warnings and precautions | In Study 1, bradycardia at treatment initiation and sinus bradycardia on ECG (defined as heart rate less than 50 bpm) occurred in 5.8% of PONVORY-treated patients compared to 1.6% of patients receiving teriflunomide 14 mg. |
| Verapamil | drug interactions | Because of the potential additive effects on heart rate, treatment with PONVORY should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties, heart rate lowering calcium channel blockers (e.g., verapamil, diltiazem), or other drugs that may … |
Source: FDA drug label (PONVORY), Vanda Pharmaceuticals Inc., effective December 4, 2025 (SPL set 0c025ba8-ba51-272e-e063-6294a90ad120), via openFDA; the full label on DailyMed
What do FAERS reports show for ponesimod?
The FDA Adverse Event Reporting System holds 428 reports that list ponesimod among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 40 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ponesimod?
8 other medicines are given the same way (oral) and in the same FDA class as ponesimod or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fingolimod | Multiple sclerosis | 21 labelers | $1.58 per capsule 0.5 mg capsule | No current entry |
| Siponimod | Multiple sclerosis | none listed | n/a | No current entry |
| Dimethyl fumarate | Multiple sclerosis | 19 labelers | $0.467 per capsule 240 mg capsule | No current entry |
| Teriflunomide | Multiple sclerosis | 15 labelers | $0.233 per tablet 14 mg tablet | No current entry |
| Dalfampridine | Multiple sclerosis | 9 labelers | $0.399 per tablet 10 mg tablet | No current entry |
| Cladribine | Multiple sclerosis | 3 labelers | n/a | No current entry |
| Diroximel fumarate | Multiple sclerosis | none listed | n/a | No current entry |
| Monomethyl fumarate | Multiple sclerosis | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ponesimod
- 8 medicines for the same use
- Other sphingosine 1-phosphate receptor modulators
- the pharmacologic class, with prices and generics
- Ponesimod side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other