Ivosidenib · Tibsovo, AG-120

What is Ivosidenib?

Ivosidenib (AG-120) is an orally available small-molecule inhibitor of mutant isocitrate dehydrogenase 1 (IDH1), particularly the R132H and R132C substitutions. By inhibiting the mutant enzyme it lowers production of the oncometabolite 2-hydroxyglutarate and promotes myeloid differentiation. It is studied in acute myeloid leukemia, chondrosarcoma and IDH1-mutated conditions.

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

At a glance

Also known as

Tibsovo, AG-120

Drug type

Small molecule

Targets

isocitrate dehydrogenase 1 (mutant IDH1) (IDH1)

Mechanism

Inhibitor of isocitrate dehydrogenase 1 (mutant IDH1) (IDH1)

Pathways

2-hydroxyglutarate (2-HG) production, myeloid differentiation, cell proliferation

Therapy area

Oncology

Developer

Servier

In trials of

AGIO, SNDX

FDA status

Approved as Tibsovo (July 20, 2018), NDA211192 · FDA label

UNII

Q2PCN8MAM6

✅ FDA-approved uses

• Newly Diagnosed Acute Myeloid Leukemia
• Relapsed or Refractory Acute Myeloid Leukemia
• Relapsed or Refractory Myelodysplastic Syndromes
• Locally Advanced or Metastatic Cholangiocarcinoma

From the indications section of the FDA label (version of Dec 22, 2025). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

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

Conditions studied

ChondrosarcomaChondrosarcoma, Grade 2Chondrosarcoma, Grade 3IDH1 Gene Mutation

Other drugs acting on IDH1

Sources

• FDA label (DailyMed)
• FDA label Tibsovo (2025-12-22), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT03013998
• ClinicalTrials.gov NCT04278781

Updated Oct 11, 2026.