Voranigo

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

GliomaBrain CancerAstrocytomaOligodendrogliomaIDH1-Mutant GliomaAstrocytoma, IDH-Mutant, Grade 3

394 competitors in Glioma

#DrugCompanyPhaseTrials

1

Paraplatin

AAvyxa

Phase 3

152

Tepadina

Alnylam Pharmaceuticals

Phase 3

13

Bicnu

MMelissa K Accordino

Phase 3

74

Voranigo

SServier

Phase 3

45

Vepesid

AAvyxa

Phase 3

46

Photofrin

PPinnacle Biologics Inc.

Phase 3

27

Ifex

BBaxter Healthcare Corporation

Phase 3

18

Accutane

CConrado Roberto Hoffmann Filho

Phase 3

19

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

110

Velban

EEastern Cooperative Oncology Group

Phase 3

1Show 27 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Glioma4 trials

Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

Recruiting·IiOMEDICO AG··NCT07240662·150 enrolled

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

Active, not recruiting·Institut de Recherches Internationales Servier·Phase 1·NCT05484622·60 enrolled

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

Active, not recruiting·SServier·Phase 3·NCT06780930·57 enrolled

Show 1 more trial

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

Active, not recruiting·Institut de Recherches Internationales Servier·Phase 3·NCT04164901·331 enrolled

Interaction2 trials

Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants

Completed·IInstitut de Recherches Internationales Servier (I.R.I.S.)·Phase 1·NCT07235748·28 enrolled

A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants

Recruiting·IInstitut de Recherches Internationales Servier (I.R.I.S.)·Phase 1·NCT07235774·28 enrolled

Oligodendroglioma2 trials

Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation

Not yet recruiting·IInstitut de Recherches Internationales Servier (I.R.I.S.)·Phase 2·NCT07286292·10 enrolled

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·SServier (Tianjin) Pharmaceutical Co. LTD.··NCT06969352·60 enrolled

ART1 trial

Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants

Not yet recruiting·IInstitut de Recherches Internationales Servier (I.R.I.S.)·Phase 1·NCT07250633·20 enrolled

Ciprofloxacin1 trial

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

Completed·SServier Bio-Innovation LLC·Phase 1·NCT05843708·64 enrolled

5 more indications

ESS1 trial

Vorasidenib Expanded Access Program

Approved for marketing·SServier··NCT05592743

Hepatic Impairment1 trial

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

Completed·Institut de Recherches Internationales Servier·Phase 1·NCT05674474·16 enrolled

Astrocytoma1 trial

Vorasidenib Maintenance for IDH Mutant Astrocytoma

Recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT06809322·468 enrolled

IDH1-mutant Glioma1 trial

A Phase 1b/2, Multicenter Study of Vorasidenib in Combination With Temozolomide (TMZ) in Participants With IDH1- or IDH2-mutant Glioma

Active, not recruiting·Institut de Recherches Internationales Servier·Preclinical·NCT06478212·51 enrolled

Astrocytoma, IDH-Mutant, Grade 31 trial

Phase III Trial of Radiotherapy Followed by Adjuvant Temozolomide in Combination With the IDH Inhibitor Vorasidenib vs Placebo in IDH-Mutated Newly-Diagnosed Grade 3 Astrocytomas

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 3·NCT07215910·408 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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