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Voranigo FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 7, 2024.

FDA Approved: Yes (First approved August 6, 2024)
Brand name: Voranigo
Generic name: vorasidenib
Dosage form: Tablets
Company: Servier Pharmaceuticals
Treatment for: Malignant Glioma

Voranigo (vorasidenib) is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor for the treatment of Grade 2 IDH-mutant glioma.

Development timeline for Voranigo

DateArticle
Aug  6, 2024Approval FDA Approves Voranigo (vorasidenib) for the Treatment of Grade 2 IDH-Mutant Glioma
Feb 20, 2024FDA and EMA Accept Vorasidenib Regulatory Submissions for the Treatment of IDH-mutant diffuse glioma
Nov 18, 2023New Analyses from Pivotal Phase 3 INDIGO Study Reinforce Vorasidenib's Potential to Change the Treatment Paradigm for IDH-Mutant Diffuse Glioma
Jun  4, 2023Servier Presents Transformational Data from Pivotal Phase 3 INDIGO Trial of Vorasidenib in Recurrent or Residual Grade 2 IDH-Mutant Diffuse Glioma

Further information

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