VORANIGO (vorasidenib) · SERVIER
Voranigo helps patients 12 years and older who have specific types of brain tumors known as Grade 2 astrocytoma or oligodendroglioma. It is used for individuals whose tumors carry a susceptible IDH1 or IDH2 mutation, which is identified through specialized testing. This medication is typically prescribed after a patient has undergone a surgical procedure,
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-08-06
- Patent Cliff
- 2039
- Routes
- ORAL
- Dosage Forms
- TABLET
VORANIGO Approval History
What VORANIGO Treats
2 indicationsVORANIGO is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Astrocytoma
- Oligodendroglioma
VORANIGO Target & Pathway
ProTarget
VORANIGO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VORANIGO
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
SERVIER's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07235774 | S095032-234 | Ph 1 | completed | A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants |
| NCT06478212 | S095032-211 | Ph 1, Ph 2 | active not recruiting | Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma |
| NCT06809322 VIGOR | EORTC -2427-BTG 2024-519404-27-00, CE.10 | Ph 3 | recruiting | Vorasidenib Maintenance for IDH Mutant Astrocytoma |
| NCT05484622 | CL1-95032-005 MK-3475-B39 | Ph 1 | active not recruiting | Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma |
| NCT07235748 | S095032-230 | Ph 1 | completed | Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants |
| NCT06780930 | CL3-95032-016 | Ph 3 | active not recruiting | Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation |
| NCT07286292 | S095032-236 | Ph 2 | not yet recruiting | Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation |
| NCT07215910 | A072301 NCI-2025-04333 | Ph 3 | recruiting | Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer |
| NCT04164901 results posted | AG881-C-004 2019-002481-13, 2024-512961-15-00 | Ph 3 | active not recruiting | Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO) |
| NCT05674474 | PKH-95032-008 | Ph 1 | completed | A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function |
| NCT07629089 VALIENT | HCC 25-076 | Ph 1 | not yet recruiting | VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VORANIGO FDA Label Details
Indications & Usage
FDA Label (PDF)VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, as detected by an FDA-approved test, following surgery including biopsy, sub-total resection, or gross total resection [see Dosage and Administration , Clinical Pharmacology and Clinical Studies ] . VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 year...
VORANIGO Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for VORANIGO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 20 active patents
Trial Analysis
- • 10 total trials
- • Stage: Growth
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment