Product Description
ONC201 is the founding member of the imipridone class of anti-cancer small molecules which selectively targets Dopamine Receptor D2 (DRD2) and ClpP. ONC201-mediated cell death occurs via induction of the integrated stress response and upregulation of apoptotic factors, such as tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL). It is dosed orally and has been well-tolerated and shown clinical activity in Phase I and II trials for specific advanced cancers. (Sourced from: https://www.chimerix.com/our-pipeline/imipridones/onc201/)
Mechanisms of Action: D2 Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Chimerix
Company Location: DURHAM NC 27713
Company CEO: Michael A. Sherman
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Brazil, Canada, Denmark, France, Germany, Hong Kong, Israel, Italy, Netherlands, Singapore, South Korea, Spain, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 13
Highest Development Phases
Phase 3: Glioma
Phase 2: Meningioma
Phase 1: Brain Cancer|Endometrial Cancer|Healthy Volunteers|Obesity|Oncology Unspecified|Urogenital Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| BIOMEDE 2 | P3 |
Recruiting |
Glioma |
2028-09-01 |
|
| PNOC022 | P2 |
Active, not recruiting |
Glioma |
2027-11-20 |
|
| ONC201-108 | P3 |
Unknown Status |
Glioma |
2026-12-15 |
|
| jRCT2051240141 | P3 |
Not yet recruiting |
Glioma |
2026-09-30 |