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Ponesimod

Ponesimod (Ponvory) is an oral medication used to treat relapsing forms of multiple sclerosis in adults.

Brand name Ponvory
Drug class Sphingosine 1-phosphate Receptor Modulator
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026
Ponesimod at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Ponvory (ponesimod) is a once-daily tablet for relapsing forms of multiple sclerosis in adults that keeps immune cells called lymphocytes in the lymph nodes, so fewer reach the brain and spinal cord. It is a newer specialist drug, on the U.S. market since about 2021. Most people tolerate it reasonably well, and what they notice most are colds and other upper respiratory infections, plus dizziness or a cough in some. Watch above all for infection: call promptly about fever or an infection that lingers, and get urgent help for new weakness, confusion or vision changes, which can signal a rare brain infection called PML.

Clinical pearls

  • Do not skip doses during the 14-day step-up, because the gradual start is what protects your heart from slowing too much.
  • Tell every prescriber you take it, since beta-blockers, verapamil, diltiazem and digoxin can slow your heart rate further.
  • Avoid live vaccines during treatment and for 1 to 2 weeks after stopping, and tell anyone vaccinating you that you take it.
  • Expect regular liver tests and blood pressure checks, and report any blurry or changed vision, which can mean fluid in the eye.
How you get itPrescription only
Comes asTablet
Earliest FDA record2021
Companies listing it with the FDA2
FDA label last updatedDec 4, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Ponesimod, written from its FDA label.

What Ponesimod is used for

▾

Ponesimod is used to treat relapsing forms of multiple sclerosis (MS) in adults.

  • Ponvory (oral tablet) is approved for relapsing-remitting MS — the most common form, marked by flare-ups followed by recovery periods
  • Ponvory is also approved for clinically isolated syndrome (CIS) — a first episode of neurological symptoms that may signal MS
  • Ponvory is approved for active secondary progressive MS — a later stage of the disease where disability gradually worsens but relapses are still occurring

How Ponesimod works

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Ponesimod binds tightly to a receptor on immune cells called the sphingosine 1-phosphate receptor 1 (S1P1). By activating this receptor, it traps lymphocytes (a type of white blood cell) inside lymph nodes, preventing them from circulating freely in the blood. With fewer lymphocytes able to travel to the brain and spinal cord, there is less immune-driven inflammation — which is what causes MS relapses and nerve damage. The exact reason this reduces MS activity isn't fully understood, but reducing immune cell migration into the central nervous system is believed to play a key role.

Ponesimod dosage

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Ponvory tablets are taken once daily by mouth and can be taken with or without food — food does not meaningfully affect how the medication works. Treatment must always begin with a 14-day gradual titration (step-up) schedule using a starter pack; skipping this step can cause significant drops in heart rate. After the titration is complete, the maintenance dose continues once daily from Day 15 onward.

  • Swallow the tablet whole
  • If you miss fewer than 4 doses in a row during titration, resume at the dose you missed and continue the schedule; if you miss 4 or more doses, you must restart the full titration with a new starter pack
  • Do not stop Ponvory suddenly without talking to your prescriber — MS symptoms can worsen significantly after stopping

Dosing details from the FDA-approved label

From the Ponesimod prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Treatment initiation (14-day titration using a starter pack)
    • Days 1 and 2: 2 mg
    • Days 3 and 4: 3 mg
    • Days 5 and 6: 4 mg
    • Day 7: 5 mg
    • Day 8: 6 mg
    • Day 9: 7 mg
    • Day 10: 8 mg
    • Day 11: 9 mg
    • Days 12, 13, and 14: 10 mg
    • Each taken orally once daily
    • Swallow the tablet whole; can be taken with or without food
  • Maintenance dosage
    • 20 mg taken orally once daily starting on Day 15
    • Swallow the tablet whole; can be taken with or without food
  • Patients with sinus bradycardia (heart rate less than 55 bpm), first- or second-degree [Mobitz type I] AV block, or a history of myocardial infarction or heart failure occurring more than 6 months prior to treatment initiation and in stable condition
    • First-dose 4-hour monitoring is recommended: monitor for 4 hours after the first dose with a minimum of hourly pulse and blood pressure measurements
    • Obtain an ECG prior to dosing and at the end of the 4-hour observation period
    • Administer the first dose in a setting where resources to manage symptomatic bradycardia are available
  • Fewer than 4 consecutive doses missed
    • During titration: resume treatment with the first missed titration dose and resume the titration schedule at that dose and titration day
    • During maintenance: resume treatment with the maintenance dosage
  • 4 or more consecutive doses missed during titration or maintenance
    • Reinitiate treatment with Day 1 of the titration regimen (new starter pack)
    • Complete first-dose monitoring in patients for whom it is recommended
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Assessments are required prior to initiating PONVORY ( 2.1 ) Titration is required for treatment initiation ( 2.2 ) The recommended maintenance dosage is 20 mg taken orally once daily ( 2.2 ) First-dose monitoring is recommended for patients with sinus bradycardia, first- or second-degree [Mobitz type I] atrioventricular (AV) block, or a history of myocardial infarction or heart failure ( 2.3 ) 2.1 Assessments Prior to First Dose of PONVORY Before initiation of treatment with PONVORY, assess the following: Cardiac Evaluation Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present. In patients with certain preexisting conditions, advice from a cardiologist should be sought and first-dose monitoring is recommended [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.2 )] . Complete Blood Count Obtain a recent (i.e., within the last 6 months or after discontinuation of prior MS therapy) complete blood count (CBC), including lymphocyte count [see Warnings and Precautions ( 5.1 )] . Determine whether patients are taking drugs that could slow heart rate or atrioventricular (AV) conduction [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.2 , 7.3 )] . Liver Function Tests Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels [see Warnings and Precautions ( 5.4 )] . Ophthalmic Evaluation Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with PONVORY [see Warnings and Precautions ( 5.8 )] . Skin Examination Obtain a baseline skin examination prior to or shortly after initiation of PONVORY. If a suspicious skin lesion is observed, it should be promptly evaluated [see Warnings and Precautions ( 5.6 )] . Current or Prior Medications with Immune System Effects If patients are taking anti-neoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment with PONVORY [see Warnings and Precautions ( 5.1 , 5.10 ) and Drug Interactions ( 7.1 )] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Ponesimod side effects

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The most common side effects of Ponvory include:

Common side effects

  • Upper respiratory tract infections (colds, bronchitis, pharyngitis)
  • Elevated liver enzymes (seen on blood tests)
  • High blood pressure (hypertension)
  • Urinary tract infection
  • Shortness of breath (dyspnea)
  • Dizziness
  • Cough
  • Somnolence (drowsiness)

When to get medical help

  • Call your doctor right away if you notice signs of infection — fever, chills, unusual fatigue, or any infection that won't go away
  • Seek emergency help for slow or irregular heartbeat, chest pain, or feeling faint, especially when starting treatment
  • Tell your doctor immediately about any changes in vision, which could signal macular edema (fluid in the eye)
  • Report any new or worsening shortness of breath or difficulty breathing
  • Call your doctor about yellowing skin or eyes, dark urine, or severe fatigue — these can signal liver injury
  • Get help urgently for unusual neurological symptoms (weakness, vision changes, confusion), which could suggest a serious brain infection
  • Tell your doctor about any new or changing skin lesions or moles — a baseline skin exam is recommended before starting

More serious reactions — including severe infections, slow or irregular heartbeat, liver injury, vision changes from macular edema, and lung function decline — require prompt medical attention. Do not ignore new or worsening symptoms, especially during the first weeks of treatment.

Ponesimod warnings and precautions

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  • Infections: Ponvory lowers your white blood cell (lymphocyte) count, raising your risk for serious infections — including herpes viruses, cryptococcal meningitis, and a rare but life-threatening brain infection called PML (progressive multifocal leukoencephalopathy). Watch for any signs of infection during treatment and for 1–2 weeks after stopping.
  • Heart rate slowing: Ponvory can transiently slow your heart rate and delay electrical conduction in the heart when you first start it. A step-up dosing schedule is required, and some patients need in-office monitoring after the first dose.
  • Liver injury: Liver enzyme elevations are common; significant liver damage can occur. Liver function tests are needed before starting.
  • Macular edema: Fluid buildup in the eye can affect vision. A baseline eye exam is recommended, with ongoing monitoring. Risk is higher in people with diabetes or a history of uveitis.
  • Lung effects: Ponvory can reduce lung function (FEV1 and FVC) in a dose-dependent way. Tell your doctor about any new breathing difficulties.
  • Skin cancers: Cases of basal cell carcinoma and melanoma have been reported. Get a baseline skin exam and have any suspicious lesions checked promptly.
  • Fetal risk: Ponvory can cause serious harm to an unborn baby. Effective contraception is essential during treatment and for 1 week after the last dose.
  • Stopping Ponvory: Do not discontinue suddenly — MS can worsen severely. Talk to your doctor before making any changes.

Ponesimod interactions

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Ponvory interacts with several types of medications that affect the heart, immune system, or liver enzymes:

  • Beta-blockers (e.g., propranolol) — add to Ponvory's heart-rate-lowering effect; temporary interruption of the beta-blocker may be needed before starting Ponvory
  • Heart-rate-slowing calcium channel blockers (e.g., verapamil, diltiazem) — increase risk of dangerously slow heart rate; cardiology guidance required
  • Digoxin — may further slow the heart rate in combination with Ponvory
  • Class Ia and Class III anti-arrhythmic drugs (e.g., amiodarone, sotalol, quinidine) — increase risk of serious heart rhythm problems, including Torsades de Pointes
  • Strong CYP3A4 and UGT1A1 inducers (e.g., rifampin, phenytoin, carbamazepine) — may lower Ponvory levels in the blood, reducing its effectiveness; combination is not recommended
  • Immunosuppressive or immune-modulating therapies — combining with Ponvory increases infection risk; alemtuzumab combination is not recommended
  • Live attenuated vaccines — should be avoided during Ponvory treatment and for 1–2 weeks after stopping; all vaccines may be less effective during treatment

Interactions listed in the FDA-approved label

From the Ponesimod prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Anti-neoplastic, immune-modulating, or immunosuppressive therapies: Not studied in combination; there is a risk of additive immune effects during such therapy and in the weeks following administration. Use caution during concomitant administration; consider the half-life and mode of action when switching from drugs with prolonged immune effects.
  • Alemtuzumab: Because of the characteristics and duration of alemtuzumab immune suppressive effects, initiating PONVORY after alemtuzumab is not recommended. Initiating treatment with PONVORY after alemtuzumab is not recommended.
  • Beta interferon or glatiramer acetate: No restriction stated on switching to PONVORY. PONVORY can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.
  • Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs: Associated with cases of Torsades de Pointes in patients with bradycardia. If treatment with PONVORY is considered, advice from a cardiologist should be sought.
  • QT prolonging 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): Potential additive effects on heart rate; PONVORY has not been studied in patients taking QT prolonging drugs. Treatment with PONVORY should generally not be initiated in these patients; if considered, seek advice from a cardiologist.
  • Beta-blockers: Additive effects on lowering heart rate when PONVORY is initiated. Apply caution; temporary interruption of the beta-blocker may be needed prior to initiation of PONVORY. Beta-blocker treatment can be initiated in patients on stable doses of PONVORY.
  • Vaccines (live attenuated): Vaccinations may be less effective during, and for up to 1 to 2 weeks after discontinuation of, PONVORY treatment; live attenuated vaccines may carry the risk of infection. Avoid live attenuated vaccines during PONVORY treatment and for 1 to 2 weeks after discontinuation.
  • Strong CYP3A4 and UGT1A1 inducers (e.g., rifampin, phenytoin, carbamazepine): May decrease the systemic exposure of ponesimod; it is unclear whether this would be of clinical relevance. Coadministration with PONVORY is not recommended.
Read the label’s full interactions text

7 DRUG INTERACTIONS Vaccines : Avoid live attenuated vaccines during and for up to 1–2 weeks after treatment with PONVORY. ( 7.4 ) Strong CYP3A4 and UGT1A1 Inducers : Coadministration with PONVORY is not recommended. ( 7.5 ) 7.1 Anti-Neoplastic, Immune-Modulating, or Immunosuppressive Therapies PONVORY has not been studied in combination with anti-neoplastic, immune-modulating, or immunosuppressive therapies. Caution should be used during concomitant administration because of the risk of additive immune effects during such therapy and in the weeks following administration [see Warnings and Precautions (5.1) ] . When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered in order to avoid unintended additive effects on the immune system [see Warnings and Precautions (5.10) ] . Because of the characteristics and duration of alemtuzumab immune suppressive effects, initiating treatment with PONVORY after alemtuzumab is not recommended. PONVORY can generally be started immediately after discontinuation of beta interferon or glatiramer acetate. 7.2 Anti-Arrhythmic Drugs, QT Prolonging Drugs, Drugs that may Decrease Heart Rate PONVORY has not been studied in patients taking QT prolonging drugs. 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. If treatment with PONVORY is considered, advice from a cardiologist should be sought. 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 decrease heart rate (e.g., digoxin) [see Warnings and Precautions (5.2) and Drug Interactions (7.3) ] .

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Ponesimod

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  • Do not take Ponvory if you had a heart attack, unstable angina, stroke, TIA, or were hospitalized for heart failure in the past 6 months
  • Do not take Ponvory if you have Mobitz type II second-degree or third-degree AV block, sick sinus syndrome, or sino-atrial block — unless you have a functioning pacemaker
  • Tell your doctor about any current infections — Ponvory should not be started until they are resolved
  • Women who can become pregnant must use effective contraception during treatment and for 1 week after stopping — animal studies showed serious fetal harm
  • Discuss breastfeeding with your doctor — it is not known whether Ponvory passes into human breast milk
  • Ponvory is not approved for use in children — safety and effectiveness in pediatric patients have not been established
  • Older adults (65+) should use Ponvory with extra caution due to a higher likelihood of heart, liver, and kidney issues
  • Ponvory is not recommended if you have moderate or severe liver impairment (Child-Pugh class B or C)
  • Tell your doctor if you have or have had diabetes or uveitis — these increase your risk of macular edema on Ponvory
  • A VZV (chickenpox) antibody test is recommended before starting; if negative, vaccination is advised at least 4 weeks before beginning Ponvory

Ponesimod overdose

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If too much Ponvory is taken — especially at the start of treatment — the main concern is an unsafe drop in heart rate and heart conduction problems (AV blocks). Monitoring with pulse checks, blood pressure measurements, and an ECG is required. There is no specific antidote, and the medication cannot be removed by dialysis. If overdose is suspected, stop the medication, seek supportive medical care, and contact a poison control center immediately.

What Ponesimod does in the body

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Ponvory causes a dose-dependent reduction in circulating lymphocytes (white blood cells) by trapping them in lymphoid tissues — within 6 hours of a dose, lymphocyte counts can fall to roughly a quarter of their starting level. It also transiently slows the heart rate and delays electrical conduction through the heart (AV conduction) starting within the first hour of dosing, peaking at 2–4 hours, and generally resolving within 4–5 hours after the first dose. Additionally, it can modestly reduce lung function (FEV1 and FVC) in a dose-dependent way. After stopping treatment, lymphocyte counts typically return to normal within 1–2 weeks.

How your body processes Ponesimod

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Ponesimod is well absorbed when taken by mouth, reaching peak blood levels about 2–4 hours after a dose, and food does not meaningfully change this. It is extensively bound to proteins in the blood (over 99%) and has a half-life of approximately 33 hours, meaning it takes about a day and a half to clear half the drug from the body. The drug is broken down in the liver through multiple enzyme pathways (including CYP3A4 and UGT enzymes), and most is eliminated in the feces. No dose adjustment is needed for kidney impairment, but Ponvory is not recommended in moderate or severe liver impairment because the drug's exposure in the body can increase significantly.

How to store Ponesimod

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Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) . Store in the original package. Protect from moisture.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

146

Supplements & herbs that interact with Ponesimod

146 supplements and herbal products have documented interactions with Ponesimod in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 8
  • Moderate · 98
  • Minor · 40
Every supplement checked against Ponesimod — ranked by severity The full interaction hub: 8 major · 98 moderate · 40 minor · every one linked to its full report. Check Ponesimod against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Ponesimod: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Ponesimod — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Ponvory supposed to do for my MS?

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Ponvory is designed to reduce the number of relapses (flare-ups) you experience and slow the progression of disability from your MS. It works by keeping certain immune cells — called lymphocytes — from reaching your brain and spinal cord, where they cause the inflammation that drives MS symptoms. It's taken every day to keep this effect going consistently.

Why do I have to do a dose step-up schedule instead of just starting at the full dose?

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Starting Ponvory can temporarily slow your heart rate, which can cause dizziness or, in some cases, more serious heart effects. The 14-day step-up schedule lets your heart gradually adjust to the medication so that the full maintenance dose is much better tolerated. Skipping or rushing this titration is not safe — if you miss 4 or more days in a row, you may need to restart the whole process from Day 1.

What side effects should I just watch for versus which ones mean I need to call someone right away?

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Common things like cold symptoms, mild dizziness, or a cough can happen and are often not serious. But you should call your doctor promptly for any signs of infection that don't improve, changes in your vision, new shortness of breath, or yellowing of your skin or eyes. If you feel your heart beating very slowly, feel faint, or have chest discomfort — especially early in treatment — get medical help right away.

Is it safe to get vaccines while I'm on Ponvory?

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Live vaccines — like certain flu shots, shingles vaccines, or MMR — should be avoided while you're on Ponvory and for 1 to 2 weeks after you stop, because the medication lowers your immune response and a live vaccine could cause an infection. Non-live vaccines can be given, but they may not work as well during treatment. Before you start Ponvory, your doctor should check whether you're immune to chickenpox and vaccinate you if you're not — at least 4 weeks before you begin the medication.

Can I take Ponvory if I'm trying to get pregnant or am already pregnant?

▾
No — Ponvory is not safe during pregnancy. Animal studies showed it can cause serious birth defects and pregnancy loss. You'll need to use effective birth control the entire time you're on Ponvory and for at least 1 week after your last dose. If you're planning a pregnancy, talk to your neurologist well in advance so you can plan a safe transition.

What happens if I just stop taking Ponvory?

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Do not stop Ponvory suddenly without talking to your doctor first. When some people stop this type of MS medication, MS activity can return — sometimes severely, causing significant worsening of symptoms. Also, your immune function takes 1 to 2 weeks to return to normal after stopping, so you'll still need to watch for signs of infection during that window. Always work with your prescriber on a plan before making any changes.

Is Ponesimod available over the counter?

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No. Ponesimod is a prescription medicine: every Ponesimod product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Ponesimod first available?

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The earliest FDA record we hold for Ponesimod is from 2021: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Ponesimod was first used.

Who makes Ponesimod?

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2 companies currently list Ponesimod products in the FDA's NDC Directory, including Janssen Pharmaceuticals, Inc, Vanda Pharmaceuticals Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Ponesimod on HelloPharmacist

Detailed data & references for Ponesimod Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ponesimod forms and strengths (how it comes)

Ponesimod is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Ponesimod inactive ingredients by manufacturer.

Tablet

By mouth
Brands Ponvory
How this form is used
What it may be used for
  • Ponvory is used to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS
Important instructions
  • Ponvory tablets are taken by mouth once daily, with or without food
  • Ponvory must be started with a 14-day step-up titration schedule using a starter pack before reaching the maintenance dose
  • Swallow the Ponvory tablet whole — do not crush or chew
  • If 4 or more consecutive Ponvory doses are missed during titration or maintenance, restart the full titration from Day 1 using a new starter pack
Available strengths 10 strengths
Show 4 more strengths Show fewer strengths
13 FDA-listed product records ⓘ

Ponesimod on the U.S. market: products, makers and brands

How Ponesimod appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2 companies list 4 Ponesimod product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2021. Brand names on the directory include Ponvory; the rest are generics.

1
Dose forms ⓘ
2
Labelers (makers, repackagers, distributors)
1
Brand names
4
FDA-listed product records ⓘ
2021
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Kit (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Janssen Pharmaceuticals, Inc50%
Vanda Pharmaceuticals Inc.50%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Compare Ponesimod products

A representative set of FDA-listed product records for Ponesimod — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
20 mg Oral Janssen Pharmaceuticals, Inc NDA View NDC →
20 mg Oral Vanda Pharmaceuticals Inc. NDA View NDC →
💊Kits
— — Janssen Pharmaceuticals, Inc NDA View NDC →
— — Vanda Pharmaceuticals Inc. NDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Ponesimod NDCs →

Ponesimod recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Ponesimod recalls since July 2021.

✅No Ponesimod recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ponesimod RxCUI 2532300 1 dose form · 10 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 2532304 In current FDA listings
    Clinical drug / strength (SCD) 2 MG RxCUI 2532314 3 MG RxCUI 2532322 4 MG RxCUI 2532327 5 MG RxCUI 2532331 6 MG RxCUI 2532335 7 MG RxCUI 2532339 8 MG RxCUI 2532343 9 MG RxCUI 2532347 10 MG RxCUI 2532305 20 MG RxCUI 2532318

Look up RxCUI 2532300 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Ponesimod brand names

Ponesimod is sold under one brand name in the FDA directory — Ponvory. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Ponvory

Who makes Ponesimod: manufacturers and labelers

2 companies list Ponesimod products with the FDA. By number of product records, the largest are Janssen Pharmaceuticals, Inc, Vanda Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Janssen Pharmaceuticals, Inc 2 Vanda Pharmaceuticals Inc. 2

Ponesimod drug class (RxNorm)

Ponesimod belongs to the Sphingosine 1-phosphate Receptor Modulator class.

Pharmacologic class Sphingosine 1-phosphate Receptor Modulator
Drug family (ATC) Sphingosine-1-phosphate (S1P) receptor modulators
How it works Sphingosine 1-Phosphate Receptor Modulators

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Ponesimod page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 4, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ponesimod.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ponesimod after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
4
Companies listing them (makers, repackagers, distributors)
2
FDA labeler codes behind them ⓘ
2
Linked representative label ⓘ
Vanda Pharmaceuticals Inc.
Linked label effective
Dec 4, 2025
Composite sections available
23
Linked SPL Set ID
0c025ba8-ba51-272e-e063-6294a90ad120
Linked SPL Document ID
5280b437-62d4-417f-bd65-eb8944a85166
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Vanda Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →