NDAORALTABLETPriority Review
Approved
Aug 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
14
Data completeness
5/8 — Partial
Priority Review
VORANIGO (vorasidenib) by R-Pharm US is isocitrate dehydrogenase 1 inhibitors [moa]. Approved for isocitrate dehydrogenase 1 inhibitor [epc]. First approved in 2024.
Drug data last refreshed 3d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VORANIGO (vorasidenib) is an oral isocitrate dehydrogenase 1 (IDH1) inhibitor approved for grade 2 IDH-mutant glioma. It works by inhibiting the mutant IDH1 enzyme, which produces the oncometabolite 2-hydroxyglutarate, thereby slowing tumor growth. This represents a precision medicine approach targeting a specific genetic mutation in a rare CNS malignancy.
Growth12.7 years to LOE
Early-stage launch in a niche oncology market with no current direct competition offers opportunity for foundational brand-building and team expansion.
Mechanism of Action
Isocitrate Dehydrogenase 1 Inhibitors
Pharmacologic Class:
Isocitrate Dehydrogenase 1 Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
Started Mar 2026
10 enrolled
Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants
Started Mar 2026
20 enrolled
Severe Hepatic ImpairmentNormal Hepatic Function
A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants
Started Nov 2025
28 enrolled
Healthy Adult Female Participants
Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer
Started Oct 2025
408 enrolled
Astrocytoma, IDH-Mutant, Grade 3
Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants
Started Oct 2025
28 enrolled
Healthy Adult Participants
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.