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Modeyso (DORDAVIPRONE)
Modeyso works by binding to dopamine receptors in the brain, which helps to slow the growth of cancer cells.
At a glance
| Generic name | DORDAVIPRONE |
|---|---|
| Sponsor | Chimerix |
| Drug class | Protease Activator [EPC] |
| Target | Dopamine |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Dordaviprone is a protease activator of the mitochondrial caseinolytic protease P (ClpP). Dordaviprone also inhibits the dopamine D2 receptor. Diffuse midline gliomas harboring an H3 K27M mutation are associated with the loss of H3 K27 trimethylation. In-vitro, dordaviprone activated the integrated stress response, induced apoptosis, and altered mitochondrial metabolism leading to restored histone H3 K27 trimethylation in H3 K27M-mutant diffuse glioma models. Dordaviprone exhibited antitumor activity in cell-based assays and in vivo models of H3 K27M-mutant diffuse glioma.
Approved indications
- diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy
- diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy
Common side effects
- Fatigue
- Headache
- Vomiting
- Nausea
- Musculoskeletal pain
- Gait disturbance
- Cranial nerve disorders
- Hemiparesis
- Dysarthria
- Dizziness
- Ataxia
- Muscular weakness
Drug interactions
- CYP3A4 Inhibitors
- CYP3A4 Inducers
- Drugs Known to Prolong QTc Interval
- Strong and Moderate CYP3A4 Inhibitors
- Strong and Moderate CYP3A4 Inducers
- Products that Prolong QTc Interval
- CYP3A4 Inhibitors
- CYP3A4 Inducers
- Drugs Known to Prolong QTc Interval
- Strong and Moderate CYP3A4 Inhibitors
- Strong and Moderate CYP3A4 Inducers
- Products that Prolong QTc Interval
Key clinical trials
- Expanded Access Use of ONC201 in a Patient With Diffuse Intrinsic Pontine Gliomas
- Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline High Grade Gliomas
- Testing for Safety and Colorectal Cancer Preventive Effects of ONC201 (PHASE1)
- Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 (PHASE3)
- A Study of ONC201 for Refractory Meningioma (PHASE2)
- ONC-201 Maintenance Therapy in Acute Myeloid Leukemia and Myelodysplastic Syndrome After Stem Cell Transplant (PHASE1)
- ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study) (PHASE3)
- Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Modeyso CI brief — competitive landscape report
- Modeyso updates RSS · CI watch RSS
- Chimerix portfolio CI