Clinical Trials

Numerous clinical trials evaluate vorasidenib across Phase I to Phase III studies for IDH-mutant grade II and III astrocytomas, oligodendrogliomas, residual or recurrent low-grade gliomas, healthy volunteers, and subjects with hepatic impairment. Sponsored by pharmaceutical companies such as Servier and Agios alongside academic and cooperative groups like Duke University and the EORTC, these protocols encompass various recruitment statuses, including recruiting, active not recruiting, completed, and approved for marketing.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06809322 RECRUITING
IDH-mutant Grade 2 or 3 Astrocytoma
European Organisation for Research and Treatment of Cancer - EORTC
 2026-01-16 PHASE3
NCT07215910 RECRUITING
Astrocytoma, IDH-Mutant, Grade 3
Alliance for Clinical Trials in Oncology
 2026-06-24 PHASE3
NCT07286292 RECRUITING
Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
Institut de Recherches Internationales Servier (I.R.I.S.)
 2026-07-23 PHASE2
NCT07703436 NOT_YET_RECRUITING
Grade 2 IDH1-mutant Glioma; Grade 3 IDH1-mutant Glioma; Glioma; IDH1-mutant Glioma; Oligodendroglioma; Oligodendroglioma IDH-1 Mutant and 1/p19q-codeleted; Astrocytoma IDH Mutant Grade 3; Astrocytoma IDH Mutant Grade 2
Nuvation Bio Inc.
 2027-03 PHASE2
NCT07629089 NOT_YET_RECRUITING
Brain Cancer
Megan Mantica
 2026-06-30 PHASE1
NCT06969352 ACTIVE_NOT_RECRUITING
Gliomas
Servier (Tianjin) Pharmaceutical Co. LTD.
 2025-09-02
NCT06478212 ACTIVE_NOT_RECRUITING
IDH1-mutant Glioma; IDH2-mutant Glioma
Institut de Recherches Internationales Servier
 2025-01-22 PHASE1; PHASE2
NCT05609994 RECRUITING
Low Grade Glioma of Brain
Katy Peters, MD, PhD
 2025-07-15 PHASE1
NCT07469735 NOT_YET_RECRUITING
Glioma; Diffuse Glioma; Recurrent Gliomas
Huashan Hospital
 2026-04-01
NCT07250633 RECRUITING
Severe Hepatic Impairment; Normal Hepatic Function
Institut de Recherches Internationales Servier (I.R.I.S.)
 2026-04-23 PHASE1
NCT06780930 ACTIVE_NOT_RECRUITING
Residual or Recurrent Grade 2 IDH Mutant Glioma
Servier
 2024-10-18 PHASE3
NCT07235774 COMPLETED
Healthy Adult Female Participants
Institut de Recherches Internationales Servier (I.R.I.S.)
 2025-11-05 PHASE1
NCT05484622 ACTIVE_NOT_RECRUITING
Astrocytoma; Oligodendroglioma
Institut de Recherches Internationales Servier
 2023-01-20 PHASE1
NCT07235748 COMPLETED
Healthy Adult Participants
Institut de Recherches Internationales Servier (I.R.I.S.)
 2025-10-07 PHASE1
NCT05609994 Not yet recruiting
Low Grade Glioma of Brain
Katy Peters MD PhD|Servier|Duke University
 2024-06 Phase 1
NCT05843708 COMPLETED
Healthy Subjects
Servier Bio-Innovation LLC
 2023-04-14 PHASE1
NCT05674474 COMPLETED
Hepatic Impairment
Institut de Recherches Internationales Servier
 2023-03-14 PHASE1
NCT05674474 Completed
Hepatic Impairment
Institut de Recherches Internationales Servier|Servier
 2023-03-14 Phase 1
NCT05484622 Recruiting
Astrocytoma
Institut de Recherches Internationales Servier|Merck Sharp & Dohme LLC|Servier
 2023-01-20 Phase 1
NCT02481154 COMPLETED
Glioma
Institut de Recherches Internationales Servier
 2015-06 PHASE1
NCT04164901 ACTIVE_NOT_RECRUITING
Grade 2 Glioma; Residual Glioma; Recurrent Glioma
Institut de Recherches Internationales Servier
 2020-01-05 PHASE3
NCT04128787 COMPLETED
Healthy Volunteers
Agios Pharmaceuticals, Inc.
 2019-09-30 PHASE1
NCT04145128 COMPLETED
Healthy Volunteers
Agios Pharmaceuticals, Inc.
 2019-10-02 PHASE1
NCT04015687 COMPLETED
Healthy Participants
Agios Pharmaceuticals, Inc.
 2019-07-15 PHASE1
NCT04145128 Completed
Healthy Volunteers
Agios Pharmaceuticals Inc.
 2019-10-02 Phase 1
NCT03960502 COMPLETED
Healthy Male Participants
Agios Pharmaceuticals, Inc.
 2019-05-16 PHASE1
NCT03343197 COMPLETED
Glioma
Institut de Recherches Internationales Servier
 2018-03-20 PHASE1
NCT02492737 COMPLETED
Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome; Hematologic Malignancies
Agios Pharmaceuticals, Inc.
 2015-08-07 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-20)

Check the Vorasidenib (AG-881) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vorasidenib is a dual inhibitor that selectively binds to mutant forms of isocitrate dehydrogenase 1 (IDH1) and 2 (IDH2), blocking the aberrant conversion of alpha-ketoglutarate to the oncometabolite 2-hydroxyglutarate (2-HG) to restore cell differentiation. By decreasing intracellular 2-HG accumulation, vorasidenib suppresses oncogenic signaling and tumor growth, providing therapeutic activity in IDH-mutant low-grade gliomas, astrocytomas, and oligodendrogliomas.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.