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Voranigo (VORASIDENIB)
Voranigo works by blocking the activity of an enzyme called isocitrate dehydrogenase 1.
Voranigo (vorasidenib) is a small molecule isocitrate dehydrogenase 1 inhibitor developed by Servier. It is approved for the treatment of Grade 2 astrocytoma and Grade 2 oligodendroglioma. Voranigo is a patented medication with a 10-day half-life. It is not yet off-patent and has no generic manufacturers. The FDA approved Voranigo in 2025.
At a glance
| Generic name | VORASIDENIB |
|---|---|
| Sponsor | Servier |
| Drug class | Isocitrate Dehydrogenase 1 Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Vorasidenib is a small molecule inhibitor that targets isocitrate dehydrogenase-1 and 2 (IDH1 and IDH2) enzymes. In vitro, vorasidenib inhibited the IDH1 wild type and mutant variants, including R132H and the IDH2 wild type and mutant variants. In cell-based and in vivo tumor models expressing IDH1 or IDH2 mutated proteins, vorasidenib decreased production of 2-hydroxyglutarate (2-HG) and partially restored cellular differentiation.
Approved indications
- Grade 2 astrocytoma
- Grade 2 oligodendroglioma
Common side effects
- Fatigue
- COVID-19
- Musculoskeletal pain
- Diarrhea
- Seizure
- Headache
- Nausea
- ALT increased
- AST increased
- GGT increased
- Neutrophils decreased
Serious adverse events
- Seizure
- ALT increased
Drug interactions
- CYP1A2 Inhibitors
- CYP1A2 Inhibitors
- CYP1A2 Inducers
- CYP3A Substrates
- Hormonal Contraception
- CYP1A2 Inhibitors
- CYP1A2 Inducers
- CYP3A Substrates
- Smoking Tobacco
- CYP1A2 Inducers
- CYP3A Substrates
- Hormonal Contraception
Key clinical trials
- A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants (PHASE1)
- Vorasidenib Guided by AGX PET in Recurrent/Low-grade Glioma (NA)
- Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma (PHASE1,PHASE2)
- Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma (PHASE1)
- Vorasidenib Maintenance for IDH Mutant Astrocytoma (PHASE3)
- Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants (PHASE1)
- Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma
- Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Voranigo CI brief — competitive landscape report
- Voranigo updates RSS · CI watch RSS
- Servier portfolio CI