NDAORALTABLETPriority Review
Approved
Aug 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
15
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 6h 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 in August 2024 by the FDA. It targets IDH1-mutant tumors by inhibiting the production of the oncometabolite 2-hydroxyglutarate. This mechanism addresses a molecularly defined patient population with dysregulated cellular metabolism driven by IDH1 mutations.
Growth12.6 years to LOE
Early-stage commercial launch with significant growth potential; brand team likely ramping up field presence and market development resources.
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 (15)
VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations
Started Jun 2026
24 enrolled
Brain Cancer
Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants
Started Apr 2026
20 enrolled
Severe Hepatic ImpairmentNormal Hepatic Function
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
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
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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.