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Also known as Dordaviprone (ONC201)
Dordaviprone · 1 trial · 2 indications
Overall Survival is defined as the time from randomization to death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Dordaviprone Twice Weekly Group | EXPERIMENTAL | - |
| Dordaviprone Once Weekly Group | EXPERIMENTAL | - |
| Placebo Group | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Dordaviprone (ONC201) | DRUG | Participants ≥ 52.5 kg will receive 625 mg of dordaviprone (5 × 125-mg capsules) dosing days; participants \< 52.5 kg will receive a dose (and corresponding number of capsules) scaled by body weight and rounded to 125-mg increments. |
| Dordaviprone (ONC201) + Placebo | DRUG | Participants ≥ 52.5 kg will receive 625 mg of dordaviprone (5 × 125-mg capsules) or matching placebo on dosing days; participants \< 52.5 kg will receive a dose (and corresponding number of capsules) scaled by body weight and rounded to 125-mg increments |
| Placebo | OTHER | Participants will receive placebo (same number of capsules as the dordaviprone dose) on dosing days |
Inclusion Criteria: 1. Able to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable. 2. Body weight ≥ 10 kg at time of randomization. 3. Histologically diagnosed ...
Dordaviprone is an investigational small molecule being studied for the treatment of H3 K27M-mutant diffuse glioma, a type of brain tumor. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Dordaviprone targets ClpP, a mitochondrial protease, and DRD2, a dopamine receptor. By interacting with these molecular targets, the drug is being evaluated for its potential therapeutic effects in H3 K27M-mutant diffuse glioma.
Dordaviprone is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol JAZZ. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Dordaviprone is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory bodies, and its safety and efficacy are still being evaluated in clinical trials.
Dordaviprone is being studied in the ACTION Study, a Phase 3 clinical trial with the identifier NCT05580562. This randomized, double-blind, placebo-controlled trial is recruiting 510 participants with H3 K27M-mutant diffuse glioma following radiotherapy, across multiple countries.
Yes, Dordaviprone is also known as ONC201. Both names refer to the same investigational drug being developed by Jazz Pharmaceuticals for the treatment of H3 K27M-mutant diffuse glioma.