# Olutasidenib

Source: https://onco.cc/drugs/olutasidenib/  
OnCo record `olutasidenib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Olutasidenib is a second IDH1 inhibitor for relapsed AML, with a higher response rate in its pivotal cohort than ivosidenib had in its own.

## Summary

Olutasidenib is a selective, allosteric inhibitor of mutant IDH1 that lowers the oncometabolite 2-hydroxyglutarate and lets blocked myeloid cells differentiate. It was approved on 1 December 2022 for relapsed or refractory IDH1-mutated AML, taken twice daily for a minimum of 6 months. In the pivotal cohort (n=147) the CR plus CRh rate was 35% with a median duration of 25.9 months, higher than ivosidenib achieved in its own pivotal cohort, although the two were not compared directly. Differentiation syndrome (16%) carries a boxed warning, and liver enzymes and QT are monitored. Forma Therapeutics developed it and licensed it to Rigel, and combination trials with azacitidine and venetoclax, and a frontline study, are ongoing. It is a second pill for the same genetic subtype of AML, working by switching differentiation back on rather than killing cells.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Rezlidhia
- Modality: Small-molecule IDH1 inhibitor
- Mechanism: Selective, allosteric mutant-IDH1 inhibitor lowering 2-HG.
- Approvals: US 2022: Relapsed/refractory IDH1-mutated AML
- Dosing: Oral; 150 mg twice daily on an empty stomach, until progression (minimum 6 months)

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Olutasidenib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Olutasidenib

## Connected records

- biomarkers: [IDH1 R132 mutation](https://onco.cc/biomarkers/idh1-r132/)
- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Astrocytoma, IDH-mutant (grades 2 to 4)](https://onco.cc/cancers/idh-mutant-astrocytoma/), [IDH1- and IDH2-mutated acute myeloid leukaemia](https://onco.cc/cancers/aml-idh/)
- technologies: [Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)](https://onco.cc/technologies/epigenetic-drugs/), [IDH inhibitors](https://onco.cc/technologies/idh-inhibitors/)
- targets: [IDH1 / IDH2](https://onco.cc/targets/idh/)
- companies: [Rigel Pharmaceuticals](https://onco.cc/companies/rigel-pharmaceuticals/)
- terms: [Differentiation syndrome](https://onco.cc/terms/differentiation-syndrome/), [Pivotal (registrational) trial](https://onco.cc/terms/pivotal-trial/)
- trials: [Study of Olutasidenib and Temozolomide in HGG](https://onco.cc/trials/nct06161974/)
- pathways: [Mutant IDH / 2-hydroxyglutarate](https://onco.cc/pathways/idh-2hg/)
- roadmaps: [Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome](https://onco.cc/roadmaps/epigenetics-roadmap/)

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