Olutasidenib
Olutasidenib is an oral targeted therapy that inhibits mutated isocitrate dehydrogenase-1 (IDH1), an enzyme that when altered promotes cancer growth. It is approved for treating adults with relapsed or refractory acute myeloid leukemia (AML) who have a susceptible IDH1 mutation, helping to reduce 2-hydroxyglutarate levels and promote normal blood cell maturation.
Olutasidenib is a targeted therapy for AML patients with IDH1 mutations, working by inhibiting the mutated enzyme to restore normal blood cell development.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01XM03
- RxNorm
- 2623641
- Generic
- Olutasidenib
- Class
- atc-l01
- Brands
- Rezlidhia
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- capsule
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Olutasidenib is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a susceptible IDH1 mutation as detected by an FDA-approved test.
As an IDH1 inhibitor, olutasidenib targets and blocks the mutated form of the IDH1 enzyme. This mutation leads to elevated 2-hydroxyglutarate (2-HG) levels, which interferes with normal blood cell differentiation. By inhibiting the mutated enzyme, olutasidenib reduces 2-HG levels and helps leukemia cells mature into normal blood cells.
IDH1 mutation testing is required before starting treatment. Common side effects may include nausea, fatigue, and liver enzyme elevations. Differentiation syndrome, a potentially serious condition, has been reported and requires prompt medical attention. Use during pregnancy is not recommended.
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy