Product Description
Vorasidenib, an investigational, oral, selective, brain-penetrant inhibitor of mutant IDH1 and IDH2 enzymes, is currently being evaluated in the registration-enabling Phase 3 INDIGO study as a potential treatment for patients with residual or recurrent Grade 2 non-enhancing glioma. (Sourced from: https://investor.agios.com/news-releases/news-release-details/agios-presents-updated-data-phase-1-dose-escalation-study)
Mechanisms of Action: IDH Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Agios
Company Location: CAMBRIDGE MA 02139
Company CEO: Jacqualyn A. Fouse
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, United States
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Glioma
Phase 1: Astrocytoma|Healthy Volunteers|Oligodendroglioma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| ViCToRy | P1 |
Not yet recruiting |
Glioma |
2027-08-01 |
|
| CL3-95032-016 | P3 |
Recruiting |
Glioma |
2026-06-30 |
|
| CL1-95032-005 | P1 |
Recruiting |
Astrocytoma|Oligodendroglioma |
2025-03-31 |
|
| PKH-95032-009 | P1 |
Completed |
Healthy Volunteers |
2023-07-28 |