Vorasidenib

Generic Name: Vorasidenib

Drug Type: Small Molecule

Chemical Formula: C_₁₄H_₁₃ClF_₆N_₆

CAS Number: 1644545-52-7

Unique Ingredient Identifier: 789Q85GA8P

Clinical Trials

A Multicentre, Retrospective-prospective Real-world Study: to Evaluate the Effectiveness and Safety of Vorasidenib in Patients With Isocitrate Dehydrogenase IDH1/2 Mutant Grade 2 Astrocytoma or Oligodendroglioma (VICTORIA Study)

Not yet recruiting

Conditions: Gliomas

Interventions: Drug: Vorasidenib

First Posted Date: 2025-05-13

Last Posted Date: 2025-05-13

Lead Sponsor: Servier (Tianjin) Pharmaceutical Co. LTD.

Target Recruit Count: 60

Registration Number: NCT06969352

Locations: 🇨🇳
West China Hospital Sichuan University, Chengdu, Sichuan, China
🇨🇳
Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China
🇨🇳
West China Lecheng Hospital Sichuan University, Qionghai, Hainan, China

Vorasidenib Maintenance for IDH Mutant Astrocytoma

Phase 3

Not yet recruiting

Conditions: IDH-mutant Grade 2 or 3 Astrocytoma

Interventions: Drug: Vorasidenib
Drug: Vorasidenib Placebo

First Posted Date: 2025-02-05

Last Posted Date: 2025-05-01

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 468

Registration Number: NCT06809322

Locations: 🇬🇧
Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom
🇦🇹
Kepler University Hospital - Neuromed campus, Linz, Austria
🇧🇪
U.Z. Leuven - Campus Gasthuisberg, Leuven, Belgium

and more 30 locations

Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation

Phase 3

Recruiting

Conditions: Residual or Recurrent Grade 2 IDH Mutant Glioma

Interventions: Drug: Vorasidenib
Drug: Placebo

First Posted Date: 2025-01-17

Last Posted Date: 2025-05-06

Lead Sponsor: Servier

Target Recruit Count: 58

Registration Number: NCT06780930

Locations: 🇨🇳
Tiantan Hospital, Beijing, China
🇨🇳
The Second People's Hospital of Shenzhen, Shenzhen, Guangdong, China
🇨🇳
West China Hospital Sichuan University, Chendu, Sichuan, China

and more 14 locations

Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma

Phase 1

Recruiting

Conditions: IDH2-mutant Glioma
IDH1-mutant Glioma

Interventions: Drug: Vorasidenib
Drug: Temozolomide (TMZ)

First Posted Date: 2024-06-27

Last Posted Date: 2025-04-08

Lead Sponsor: Institut de Recherches Internationales Servier

Target Recruit Count: 42

Registration Number: NCT06478212

Locations: 🇺🇸
University of California, San Francisco (UCSF) School of Medicine, San Francisco, California, United States
🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸
University of California Los Angeles, Los Angeles, California, United States

and more 29 locations

A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: Vorasidenib 40 mg Oral Tablet
Drug: Vorasidenib 10 mg Oral Tablet
Drug: Ciprofloxacin 500 mg Oral Tablet

First Posted Date: 2023-05-06

Last Posted Date: 2025-02-14

Lead Sponsor: Servier Bio-Innovation LLC

Target Recruit Count: 64

Registration Number: NCT05843708

Locations: 🇺🇸
PPD Development, Austin, Texas, United States

A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function

Phase 1

Completed

Conditions: Hepatic Impairment

Interventions: Drug: Vorasidenib

First Posted Date: 2023-01-06

Last Posted Date: 2024-02-08

Lead Sponsor: Institut de Recherches Internationales Servier

Target Recruit Count: 16

Registration Number: NCT05674474

Locations: 🇺🇸
American Research Corporation, San Antonio, Texas, United States

Vorasidenib Expanded Access Program

Conditions: Glioma
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

First Posted Date: 2022-10-25

Last Posted Date: 2024-11-05

Lead Sponsor: Servier

Registration Number: NCT05592743

Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma

Phase 1

Recruiting

Conditions: Astrocytoma
Oligodendroglioma

Interventions: Drug: Vorasidenib
Drug: Pembrolizumab

First Posted Date: 2022-08-02

Last Posted Date: 2025-01-14

Lead Sponsor: Institut de Recherches Internationales Servier

Target Recruit Count: 72

Registration Number: NCT05484622

Locations: 🇺🇸
Northwestern University (Site: 840123), Chicago, Illinois, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Mayo Clinic Florida, Cleveland, Ohio, United States

and more 13 locations

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

Phase 3

Active, not recruiting

Conditions: Grade 2 Glioma
Residual Glioma
Recurrent Glioma

Interventions: Drug: Vorasidenib
Drug: Matching Placebo

First Posted Date: 2019-11-15

Last Posted Date: 2025-04-03

Lead Sponsor: Institut de Recherches Internationales Servier

Target Recruit Count: 331

Registration Number: NCT04164901

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
University of California San Diego, La Jolla, California, United States

and more 81 locations

A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: AG881

First Posted Date: 2019-10-30

Last Posted Date: 2020-04-02

Lead Sponsor: Agios Pharmaceuticals, Inc.

Target Recruit Count: 32

Registration Number: NCT04145128

Locations: 🇺🇸
WCCT GLobal, Cypress, California, United States

Drug Development Updates

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