MODEYSO (dordaviprone hydrochloride)
MODEYSO is indicated for the treatment of Diffuse Midline Glioma.
How MODEYSO Works
Dordaviprone is a small-molecule protease activator of mitochondrial caseinolytic protease P (ClpP) and an antagonist of the dopamine D2 receptor. In H3 K27M-mutant diffuse glioma models, dordaviprone activates the integrated stress response, induces apoptosis, and alters mitochondrial metabolism. These actions lead to the restoration of histone H3 K27 trimethylation, which is typically lost in this specific mutation, thereby exerting antitumor activity.
Details
- Status
- Prescription
- First Approved
- 2025-08-06
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- CAPSULE
MODEYSO Approval History
What MODEYSO Treats
1 indicationsMODEYSO is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diffuse Midline Glioma
MODEYSO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05630794 | NCI-2022-09737 NCI-2022-09737, UMCC 2022.038 | Ph 1 | recruiting | Testing for Safety and Colorectal Cancer Preventive Effects of ONC201 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MODEYSO FDA Label Details
Indications & Usage
FDA Label (PDF)MODEYSO is indicated for the treatment of Diffuse Midline Glioma.
MODEYSO Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for MODEYSO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 7 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.