olutasidenib
olutasidenib: developed by 1 company · 9 clinical trials tracked · 1 FDA decision.
olutasidenib evidence translation
What we can confirm
1 FDA record · 9 tracked trials
What it means
What to watch
Prepared research question
How could olutasidenib → RIGL affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence7 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| RIGEL PHARMACEUTICALS INC (RIGL) relapsed or refractory (R/R) acute myeloid leukemia (AML) wi… | Approved |
Clinical Trials (9)
Pilot Single Arm Phase 2 Study of Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
Primary endpoint: Composite complete remission rate
Single-Arm Phase 2 Study of Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Who Are Eligible for Intensive Induction Chemotherapy
Primary endpoint: Number of Participants Experiencing Excessive Toxicity
A Multi-Center, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Olutasidenib on the Pharmacokinetics of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates in Patients With IDH1 Mutation-Positive Malignancies Being Treated With Olutasidenib
Primary endpoint: Area Under the Plasma Concentration-Time Curve (AUC) of Probe Drugs
Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations
Primary endpoint: Safety and adverse events (AEs)
A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm
Primary endpoint: Safety and adverse events (AEs)
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
Primary endpoint: Safety and adverse events (AEs)
Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib
Primary endpoint: Safety and adverse events (AEs)
Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials
Primary endpoint: Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment
A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation
Primary endpoint: Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
FDA Decisions1 records
Frequently asked questions
Who is developing olutasidenib?
olutasidenib is being developed by RIGEL PHARMACEUTICALS INC.
How many clinical trials involve olutasidenib?
BioSniper tracks 9 clinical trials involving olutasidenib.
What is olutasidenib's latest FDA decision?
The most recent tracked FDA decision for olutasidenib is Approval for 1 INDICATIONS AND USAGE Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )] . REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with , dated December 1, 2022.