NDA 219876, held by Chimerix. Dordaviprone Hydrochloride.
As of Nov 14, 2026, NDA 219876 (Modeyso), held by Chimerix, was first approved by FDA on Aug 6, 2025, with 0 approved supplements and 0 published complete response letters.
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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2025 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ModeysoEQ 125MG BASE · capsule;oral | Dordaviprone Hydrochloride | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
