Back to discover
Drug

Vorasidenib

Approved · FDA / EMA
Late-stage development

Also known as Voranigo.

RxNorm2690647ChEMBLCHEMBL4279047UNII789Q85GA8P
9
Active clinical trials
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-07-08Results expected Q4 2027 · ClinicalTrials.gov

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

Clinical trial2026-07-02Results expected Q2 2033 · ClinicalTrials.gov

Label change: VORASIDENIB (NDA218784)

Regulatory2026-06-10FDA

A Phase 1, Open-Label, Non-randomized, Single Dose, Safety, Tolerability, and Pharmacokinetic Study of Vorasidenib Administered to Participants With Severe Hepatic Impairment and Matched-Participants With Normal Hepatic Function

Clinical trial2026-06-05Results expected Q4 2026 · ClinicalTrials.gov

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

Clinical trial2026-06-05Results expected Q2 2030 · ClinicalTrials.gov

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)

Clinical trial2026-05-22Results expected Q2 2035 · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Double-blind, Placebo- Controlled Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

Clinical trial2026-05-07Primary completion · ClinicalTrials.gov

A Phase 1, Open-label, Single-sequence, 2-period Study to Determine the Effects of Repeated Oral Dosing of Vorasidenib on the Pharmacokinetics, Safety and Tolerability of a Combined Oral Contraceptive in Healthy Female Participants.

Clinical trial2026-03-13Completed · ClinicalTrials.gov

A Phase 1, Safety Lead-In and Randomized, Open-label, Perioperative Study of Vorasidenib in Combination With Pembrolizumab in Subjects With Recurrent or Progressive IDH-1 Mutant Glioma

Clinical trial2026-02-12Primary completion · ClinicalTrials.gov

Approval: Voranigo (EMA)

Regulatory2025-09-17EMA

Label change: VORASIDENIB (NDA218784)

Regulatory2025-04-08FDA

Approval: VORASIDENIB (NDA218784)

Regulatory2024-08-06FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Vorasidenib
Aliases & brands
Voranigo
RxNorm CUI
2690647
ChEMBL ID
CHEMBL4279047
UNII
789Q85GA8P
Regulatory jurisdictions
emafda

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2024-08-06 → 2025-09-17)
Earliest approval
2024-08-06
Latest approval
2025-09-17
Authorities
FDA · EMA
Total events
4
fdaU.S. Food and Drug Administration· 3 events
2026-06-10Label change
Label change: VORASIDENIB (NDA218784)
Evidence ↗
2025-04-08Label change
Label change: VORASIDENIB (NDA218784)
Evidence ↗
2024-08-06ApprovalMulti-authority
Approval: VORASIDENIB (NDA218784)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2025-09-17ApprovalMulti-authority
Approval: Voranigo (EMA)
Indication: Voranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in… Show full indication

Voranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

13 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
13
registered trials across all phases
LATEST COMPLETION 2026
9
Active studies
5
Recruiting
4
Late-stage (III+)
4
Completed
PHASE DISTRIBUTIONn = 13
Phase 17Phase 1 / 21Phase 21Phase 34

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

RecruitingPH IIIAlliance for Clinical Trials in Oncologyn=4082040

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)

RecruitingPH IIIEuropean Organisation for Research and Treatment of Cancer - EORTCn=4682037

A Phase 3, Multicenter, Randomized, Double-blind, Placebo- Controlled Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

Active, not recruitingPH IIIServiern=572030

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

Active, not recruitingPH IIIInstitut de Recherches Internationales Serviern=3312028

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Open-label, Single-sequence, 2-period Study to Determine the Effects of Repeated Oral Dosing of Vorasidenib on the Pharmacokinetics, Safety and Tolerability of a Combined Oral Contraceptive in Healthy Female Participants.

CompletedPH IInstitut de Recherches Internationales Servier (I.R.I.S.)n=282026

A Phase 1, Open-label, Single-sequence, 2-period Study to Evaluate the Effect of Multiple Doses of Vorasidenib on the Pharmacokinetics of a Single Dose of Sensitive Index Substrates of Cytochrome P450 2B6, 2C8, 2C9, 2C19, 3A4, and Breast Cancer Resistance Protein in Healthy Adult Participants

CompletedPH IInstitut de Recherches Internationales Servier (I.R.I.S.)n=282025

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

CompletedPH IServier Bio-Innovation LLCn=642023

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a 20-mg Dose of Vorasidenib in Subjects With Moderate or Mild Hepatic Impairment and Matched Subjects With Normal Hepatic Function

CompletedPH IInstitut de Recherches Internationales Serviern=162023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.