Dashboard PDUFA PDUFA History Dilution Watch Downside Radar Missed Milestones Earnings Big Movers Blog

🎤 Upcoming Biotech Conferences

Loading conferences...
Free to browse, no account needed Follow the companies behind these drugs with free AI briefings, catalyst countdowns and dilution alerts.

Vorasidenib · Voranigo, AG-881

Small molecule · Inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) · developed by Servier

Approved FDA, Aug 2024
3 Registered trials

What is Vorasidenib?

Vorasidenib is a small molecule inhibitor of mutant isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2). It decreases production of the oncometabolite 2-hydroxyglutarate and restores cellular differentiation in tumors with IDH mutations.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Voranigo, AG-881, AGI 23088, AGI 0023088
Drug type
Small molecule
Targets
isocitrate dehydrogenase-1 (IDH1), isocitrate dehydrogenase-2 (IDH2)
Mechanism
Inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2)
Pathways
2-hydroxyglutarate production, cellular differentiation, cellular proliferation
Therapy area
Oncology
Developer
Servier
In trials of
AGIO
FDA status
Approved as Voranigo (August 6, 2024), NDA218784 · FDA label
UNII
789Q85GA8P

✅ FDA-approved uses

From the indications section of the FDA label (version of Jun 19, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT04145128 Phase 1 Healthy Volunteers Completed AGIO
NCT04128787 Phase 1 Healthy Volunteers Completed AGIO
NCT03960502 Phase 1 Healthy Male Participants Completed AGIO

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Healthy Male ParticipantsHealthy Volunteers

Other drugs acting on IDH1 / IDH2

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.