Friday, July 10, 2026

Drug profile · INN

dordaviprone hydrochloride

dordaviprone hydrochloride (MODEYSO) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 5
News articles 0
Drug details — dordaviprone hydrochloride
US status
approved
Class
Route
ORAL
Patents
0
Programs
5
Data quality
0.84

Quick answer

dordaviprone hydrochloride (MODEYSO) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN dordaviprone hydrochloride
Brand MODEYSO
Route ORAL
Formulation CAPSULE

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Dordaviprone (ONC201) Phase 3 · Jazz Pharmaceuticals Ireland · H3 K27M
  2. Dordaviprone (ONC201) Phase 2 · Jazz Pharmaceuticals Ireland · Glioma
  3. Dordaviprone (ONC201) Phase 2 · Jazz Pharmaceuticals Ireland · Endometrial Cancer Recurrent
  4. Dordaviprone (ONC201) Phase 2 · Jazz Pharmaceuticals Ireland · Glioblastoma
  5. Dordaviprone (ONC201) Phase 1 · Jazz Pharmaceuticals Ireland · Diffuse Intrinsic Pontine Glioma

Frequently asked questions

What is dordaviprone hydrochloride?

dordaviprone hydrochloride (MODEYSO) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for dordaviprone hydrochloride?

MODEYSO is a marketed brand name for dordaviprone hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of dordaviprone hydrochloride?

dordaviprone hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.