Modeyso

Pronunciation: moh-DAY-soh
Generic name: dordaviprone
Dosage form: capsule (125mg)

Medically reviewed by Melisa Puckey, BPharm. Last updated on Aug 10, 2025.

What is Modeyso?

Modeyso (dordaviprone) is used to treat diffuse H3 K27M-Mutant diffuse midline glioma, a rare, aggressive brain tumor. Modeyso is a protease activator that helps to slow cancer growth and causes cancer cells to die. Modeyso can be used by adults and pediatric patients 1 year and older if their disease has progressed after therapy.

Modeyso works (mechanism of action) by activating an enzyme called ClpP (mitochondrial caseinolytic protease P) and inhibiting the dopamine D2 receptor. 

Modeyso is administered as an oral capsule taken once a week, swallowed whole on an empty stomach (at least 1 hour before or 3 hours after food intake). For patients unable to swallow capsules, the capsule may be opened and the contents mixed with approximately 15 to 30 mL of liquid before administration. 

Modeyso FDA approval 

Modeyso's FDA approval was granted on August 6, 2025, and is the first and only treatment option approved for diffuse midline glioma harboring an H3 K27M mutation. The FDA accelerated approval was based on positive results from the clinical trials ONC006, ONC013, ONC014, ONC016, and ONC018. 

Modeyso clinical trial results demonstrated an:

• Overall response rate (ORR): 22%
• Median duration of response (DOR): 10.3 months
• Of those with objective responses, 73% response duration of ≥6 months, and 27% response duration of ≥12 months.

Modeyso side effects

Common Modeyso side effects are tiredness (fatigue), headache, vomiting, nausea, and muscle and joint pain.

Modeyso may cause changes in laboratory results, including low white blood cells, decreased red blood cells, decreased calcium, and high liver enzymes.

Serious side effects

Pediatric Modeyso dose

Modeyso may cause serious side effects, including allergic reactions and heart rhythm problems (QTc interval prolongation).

This medication may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

Allergic reactions. Modeyso may cause allergic reactions, which can be severe. Stop taking this medicine and get immediate emergency medical help right away if you get any signs or symptoms of allergic reactions, including: 

• rash 
• hives 
• feeling faint or dizzy 
• wheezing or trouble breathing
• swelling of the face or throat

Heart rhythm problems (QTc interval prolongation). This medicine can cause changes in the electrical activity of your heart and can increase your chance of getting a type of abnormal heart rhythm that can lead to sudden death called torsades de pointes. Your healthcare provider will check your heart using an electrocardiograph (ECG) and check your blood levels of salts called electrolytes before you start treatment and during treatment as needed. Get emergency medical help right away if you get any signs or symptoms of abnormal heart rhythm, including: 

• feeling lightheaded or faint 
• dizziness
• fast heartbeat
• heart palpitations
• shortness of breath.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking this medicine

Before taking this medicine, tell your healthcare provider about all your medical conditions, including if you: 

• have heart failure or heart rhythm problems, including QT prolongation and long QT syndrome.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. This medicine can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment

• You will be required to do a pregnancy test before treatment to confirm that you are not pregnant.
• Females who are able to become pregnant should use effective birth control (contraception) during treatment with Modeyso and for 1 month after your last dose. 
• Males with partners who are able to become pregnant should use effective contraception during treatment with this medicine and for 1 month after their last dose. 

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

Do not breastfeed during treatment with Modeyso and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Fertility

Modeyso may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

How should I take Modeyso?

Take Modeyso 1 time each week on the same day of the week. 

Swallow Modeyso capsule whole, on an empty stomach, at least 1 hour before or 3 hours after eating food.

If you can not swallow capsules, the capsule may be opened and the contents mixed with approximately 15 to 30 mL of liquid (sports drink, apple juice, lemonade, or water) before administration. See the detailed Instructions for Use for how to prepare and take or give as a liquid.

If you vomit after taking Modeyso, do not take another dose; take the next dose on the next regularly scheduled weekly day of the week. 

Take this medicine exactly as your healthcare provider tells you. Do not change your dose or stop taking it without talking to your healthcare provider. 

Your healthcare provider may change your dose, temporarily stop, or completely stop treatment if you develop certain side effects. 

What happens if I miss a dose?

If you miss a weekly dose by 2 days or less, then you should take the missed dose as soon as you remember. Then take the next dose of Modeyso on the next regularly scheduled day of the week. If you miss your weekly dose by more than 2 days, then skip the missed dose and take the next dose on the next regularly scheduled day of the week.

Dosing information 

Adult Modeyso dose

The recommended adult dose is 625mg once weekly

Pediatric Modeyso dose

The recommended pediatric dose in patients aged 1 to <17 years who weigh at least 10 kg is based on body weight.

Dose modifications

Dose modifications are required due to adverse reactions or medication interactions.

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Modeyso and other medicines may affect the way each other work and may cause serious side effects. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start or stop taking any new medicines without first talking to your healthcare provider. 

CYP3A4 Inhibitors: Avoid using Modeyso with strong and moderate CYP3A4 inhibitors. If using these medicines together cannot be avoided for adults and pediatric patients who weigh at least 52.5 kg, reduce the dose of MODEYSO as recommended.

CYP3A4 Inducers: Avoid using Modeyso with the strong and moderate CYP3A4 inducers.

Drugs Known to Prolong QTc Interval: Avoid using Modeyso with products known to prolong the QTc interval. If concomitant use cannot be avoided, separate administration of Modeyso and the QT-prolonging product.

This list is not complete. Many other drugs may interact with this medicine, and not all possible interactions are listed in this document.

Modeyso Package Insert

HCPs and patients often use the Modeyso Package Insert for more detailed information about this medicine. The Modeyso PI contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not replace the need to discuss your treatment with your doctor.

Package Insert is sometimes Modeyso Prescribing Information (PI) or FDA label.

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C). • The MODEYSO bottle has a child-resistant closure.

Ingredients

Active ingredient: dordaviprone 

Inactive ingredients: magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell contains hypromellose and titanium dioxide. The black printing ink contains alcohol, D&C yellow #10, FD&C blue #1, FD&C blue #2, FD&C red #40, ferrosoferric oxide, methyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze (20% esterified).

Company

Modeyso Jazz Pharmaceuticals, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer