# ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)

> **NCT05580562** · PHASE3 · RECRUITING · sponsor: **Jazz Pharmaceuticals** · enrollment: 510 (estimated)

## Conditions studied

- H3 K27M
- Glioma

## Interventions

- **DRUG:** Dordaviprone (ONC201)
- **DRUG:** Dordaviprone (ONC201) + Placebo
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT05580562
- **Lead sponsor:** Jazz Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-01-23
- **Primary completion:** 2028-06
- **Final completion:** 2028-06
- **Target enrollment:** 510 (ESTIMATED)
- **Last updated:** 2026-04-16

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05580562

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05580562, "ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)". Retrieved via AI Analytics 2026-06-16 from https://api.ai-analytics.org/clinical/NCT05580562. Licensed CC0.

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