Drugs / Vorasidenib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diffuse astrocytoma 1 milestone | |||||
| Filed | US (FDA) | — | diffuse astrocytoma | 2024-05-02 | “Servier announced FDA filing acceptance and priority review for a new drug application (NDA) for vorasidenib for the treatment of IDH-mutant diffuse glioma.” agios.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Voranigo | — | 2025-09-17 | europa.eu ↗ |
| Approved | US (FDA) | VORANIGO | — | 2024-08-06 | fda.gov ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials | ||||||
| Phase 1 | NCT07629089 | Jun 2026 → Jun 2030 expected | brain cancer | Megan Mantica | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07250633 | Apr → Nov 2026 expected | liver disease, severe congenital | Servier | Recruiting | No outcome recorded |
| Phase 1 | NCT07235774 | Nov 2025 → Mar 2026 | — | Servier | Completed | No outcome recorded |
| Phase 1 | NCT07235748 | Oct → Dec 2025 | — | Servier | Completed | No outcome recorded |
| Phase 1 | NCT05609994 | Jul 2025 → Aug 2027 expected | low grade glioma | Katy Peters, MD, PhD | Recruiting | No outcome recorded |
| Phase 1 | NCT05843708 | Apr → Jul 2023 | — | Servier Bio-Innovation LLC | Completed | No outcome recorded |
| Phase 1 | NCT05674474 | Mar → Jul 2023 | — | Servier | Completed | No outcome recorded |
| Phase 1 | NCT05484622 | Jan 2023 → Feb 2026 overdue | astrocytoma (excluding glioblastoma), oligodendroglioma | Servier | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04145128 | Oct → Dec 2019 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04128787 | Sep → Dec 2019 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04015687 | Jul → Oct 2019 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03960502 | May → Sep 2019 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03343197 | Mar 2018 → Aug 2019 | low grade glioma | Servier | Completed | No outcome recorded |
| Phase 1 | NCT02492737 | Aug 2015 → Mar 2018 | acute myeloid leukemia, myelodysplastic syndrome | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02481154 | Jun 2015 → Oct 2022 | glioma | Servier | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06478212 | Jan 2025 → Nov 2027 expected | glioma | Servier | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07286292 | Jul 2026 → May 2033 expected | grade II glioma | Servier | Recruiting | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT07215910 | Jun 2026 → May 2033 expected | astrocytoma, IDH-mutant, grade 3 | Alliance for Clinical Trials in Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT06809322 | Jan 2026 → Apr 2035 expected | astrocytoma (excluding glioblastoma) | European Organisation for Research and Treatment of Cancer - EORTC | Recruiting | No outcome recorded |
| Phase 3 | NCT06780930 | Oct 2024 → May 2026 overdue | grade II glioma | Servier | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04164901 | Jan 2020 → Sep 2022 overdue | grade II glioma | Servier | Active not recruiting | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT07469735 | Apr 2026 → Jun 2027 expected | glioma | Huashan Hospital | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05592743 | — | glioma | Servier | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2020-05-29 | Agios Pharmaceuticals, Inc. | Results Agios Presents Updated Data from the Phase 1 Dose-escalation Study of Vorasidenib in Patients with IDH-mutant Non-enhancing Glioma agios.com ↗
Vorasidenib Demonstrated Prolonged Disease Control and Encouraging Preliminary Activity with Median Progression-free Survival of 31.4 Months |
| 2019-11-22 | Agios Pharmaceuticals, Inc. | Results Agios Presents New Pharmacodynamic and Response Data from Both Cohorts of the Perioperative Study of Vorasidenib and TIBSOVO® (ivosidenib) in Patients with IDH1 Mutant Positive Low-Grade Glioma agios.com ↗
Preliminary Efficacy Data Show 31% Overall Response Rate for Both Vorasidenib and TIBSOVO ® with Postoperative Treatment |
| 2018-11-16 | Agios Pharmaceuticals, Inc. | Results Agios Presents Updated Data from Phase 1 Dose-Escalation Study of AG-881 in Patients with IDH Mutant Positive Advanced Glioma agios.com ↗
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today presented updated data from the ongoing Phase 1 study evaluating single agent AG-881 in advanced glioma. |
| 2018-06-01 | Agios Pharmaceuticals, Inc. | Results Agios Presents Data from Phase 1 Dose-Escalation Study of AG-881 in Patients with IDH Mutant Positive Advanced Glioma and Other Solid Tumors agios.com ↗
The AG-881 Phase 1 dose-escalation data are encouraging, as they demonstrate a favorable safety profile at lower dose levels and show signals of clinical activity that support further evaluation of the role of inhibiting mutant IDH in low-grade glioma. |
All press releases naming this drug 9 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | vorasidenib | “Vorasidenib (AG-881) is a first-in-class, brain-penetrant, dual inhibitor of the mutant IDH1 and mutant IDH2 enzymes.” PMID 34078652 ↗ Jun 2021 |
| Known as | AG-881 | “Vorasidenib (AG-881) is a first-in-class, brain-penetrant, dual inhibitor of the mutant IDH1 and mutant IDH2 enzymes.” PMID 34078652 ↗ Jun 20219“AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle prior to surgery.” NCT03343197 ↗ “Vorasidenib (AG881) is an orally available brain-penetrant dual inhibitor of mutant IDH1 and IDH2 proteins.” NCT06809322 ↗ “single oral doses of 10 mg and 50 mg of AG-881.” NCT04145128 ↗ |
| Known as | AG-881 citrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4279047 ↗ |
| Known as | vorasidenib citrate | “Vorasidenib citrate blocks the proteins made by the mutated IDH1 and IDH2 genes, which may help keep tumor cells from growing.” NCT07215910 ↗ |
| Action | Inhibit | “dual inhibitor of the mutant IDH1 and mutant IDH2 enzymes” PMID 34078652 ↗ Jun 2021 |
| Modality | Small molecule | — CHEMBL4279047 ↗ |
| Route | Oral | “Vorasidenib was administered orally” PMID 34078652 ↗ Jun 2021 |
| Target | IDH1 | “dual inhibitor of the mutant IDH1 and mutant IDH2 enzymes” PMID 34078652 ↗ Jun 2021 |
| Target | IDH2 | “dual inhibitor of the mutant IDH1 and mutant IDH2 enzymes” PMID 34078652 ↗ Jun 2021 |