Prescription medicine

Dordaviprone Brand names: Modeyso

Dordaviprone (Modeyso) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the dordaviprone FDA label on DailyMed (effective January 9, 2026, Jazz Pharmaceuticals, Inc.); the NDA 219876 record on Drugs@FDA; every dordaviprone label on DailyMed.

Highlights of the record

FDA label of January 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

Forms and strengths

125 mg

Capsule.

On the market

Earliest approval on file: August 6, 2025 Modeyso, Chimerix; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: January 30, 2037 Modeyso capsules; 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: 77 through July 30, 2026

What is dordaviprone used for?

From the label: indications and usage
MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). […]

FDA pharmacologic class: Protease Activator.

Source: FDA drug label (MODEYSO), NDA219876 (Chimerix), as published by Jazz Pharmaceuticals, Inc., effective January 9, 2026 (SPL set ad45b43e-fdef-47ad-9c34-055b41bdc576), via openFDA; the full label on DailyMed

Is there a generic for dordaviprone (Modeyso)?

No generic dordaviprone is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 7 patents for Modeyso capsules, the last expiring on January 30, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2025 earliest approval on file
2037 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for dordaviprone?

The FDA Adverse Event Reporting System holds 77 reports that list dordaviprone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 48 are coded as a death and 18 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

Death (an outcome recorded in the report)43
Fatigue (named in the label)8
Neoplasm Progression7
Disease Progression (a use or a product term, not a reaction)6
Nausea (named in the label)6
Asthenia (named in the label)4
Constipation (named in the label)4
Hospice Care4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Dordaviprone side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other