Voranigo

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

ARTGliomaInteractionOligodendrogliomaIDH1-Mutant GliomaGliomas

91 competitors in ART

#DrugCompanyPhaseTrials

1

Belamaf

GSK

Phase 3

32

Venclexta

AbbVie

Phase 3

23

Rituxan

Roche

Phase 3

14

Voranigo

SServier

Phase 3

15

Toradol

JJavelin Pharmaceuticals

Phase 3

16

Brukinsa

BBeOne Medicines

Phase 3

17

Treanda

AAzurity Pharmaceuticals

Phase 3

18

Attruby

NNavire Pharma Inc., a BridgeBio company

Phase 3

19

Cysteine Hydrochloride

Novartis

Phase 2

110

Noradrenaline

IInstitute of Liver and Biliary Sciences, India

Phase 3

1Show 34 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Glioma5 trials

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

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

Show 2 more trials

Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

Recruiting·IiOMEDICO AG··NCT07240662·150 enrolled

The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma or for Participants in Japan With Diffuse Glioma With IDH1 or IDH2 Mutations Who Have Undergone Surgery as Their Only Treatment

Approved for marketing·SServier··NCT05592743

Interaction2 trials

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

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

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

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

7 more indications

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

Recurrent Glioma1 trial

VALIENT: Phase 1 Clinical Trial of VorAsidenib in Combination With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations

Not yet recruiting·MMegan Mantica·Phase 1·NCT07629089·36 enrolled

Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 41 trial

A Multicenter Safety and Immunogenicity Window-of-opportunity Phase 1 Interventional Trial Assessing the Combination of IDH1 Vaccine (IDH1-vac) and Vorasidenib in Adult Patients With Recurrent IDH1R132H-mutant Astrocytoma, Grade 2 - 4 (iVOCAL)

Not yet recruiting·HHeidelberg University·Phase 1·NCT07877415·45 enrolled

Astrocytoma1 trial

Vorasidenib as Maintenance Treatment After First-line Chemoradiotherapy in IDH-mutant Grade 2 or 3 Astrocytoma: a Placebo-controlled, Triple-blind, Randomized Phase III Study (VIGOR)

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

Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation1 trial

A Phase 2, Single Arm, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Vorasidenib in Pediatric Participants Aged 12 to < 18 Years Old With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation

Recruiting·IInstitut de Recherches Internationales Servier (I.R.I.S.)·Phase 2·NCT07286292·10 enrolled

Gliomas1 trial

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)

Active, not recruiting·SServier (Tianjin) Pharmaceutical Co. LTD.·Preclinical·NCT06969352·62 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

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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