Wednesday, July 8, 2026

Drug profile · INN

olutasidenib

olutasidenib (REZLIDHIA) is a isocitrate dehydrogenase [nadp] cytoplasmic inhibitor. Associated with RIGEL PHARMACEUTICALS INC. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 20
Pipeline programs 9
News articles 0
Drug details — olutasidenib
US status
approved
Class
Route
ORAL
Patents
20
Programs
9
Data quality
0.89

Quick answer

olutasidenib (REZLIDHIA) is a isocitrate dehydrogenase [nadp] cytoplasmic inhibitor. Associated with RIGEL PHARMACEUTICALS INC. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN olutasidenib
Brand REZLIDHIA
Mechanism Isocitrate dehydrogenase [NADP] cytoplasmic inhibitor
Target Isocitrate dehydrogenase [NADP] cytoplasmic
Route ORAL
Formulation CAPSULE

Mechanism of action

Isocitrate dehydrogenase [NADP] cytoplasmic inhibitor

Primary target: Isocitrate dehydrogenase [NADP] cytoplasmic

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Olutasidenib Phase 2 · Atrium Therapeutics · IDH1 Mutation
  2. Olutasidenib Phase 2 · RIGEL PHARMACEUTICALS · Myelodysplastic Syndromes
  3. Olutasidenib Phase 2 · RIGEL PHARMACEUTICALS · Targeted Therapy
  4. Olutasidenib Phase 2 · RIGEL PHARMACEUTICALS · Acute Myeloid Leukemia
  5. Olutasidenib Phase 2 · RIGEL PHARMACEUTICALS · Chronic Myelomonocytic Leukemia
  6. Olutasidenib Phase 2 · RIGEL PHARMACEUTICALS · Mutant IDH1 Inhibitor Olutasidenib
  7. Olutasidenib + TMZ Phase 2 · RIGEL PHARMACEUTICALS · High Grade Glioma
  8. Olutasidenib Investigational Agent Administration Phase 1 · RIGEL PHARMACEUTICALS · Acute Myeloid Leukemia

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Frequently asked questions

What is olutasidenib?

olutasidenib (REZLIDHIA) is a isocitrate dehydrogenase [nadp] cytoplasmic inhibitor. Associated with RIGEL PHARMACEUTICALS INC. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for olutasidenib?

REZLIDHIA is a marketed brand name for olutasidenib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of olutasidenib?

olutasidenib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.