REZLIDHIA (olutasidenib)
REZLIDHIA is indicated for the treatment of Acute Myeloid Leukemia.
How REZLIDHIA Works
Olutasidenib is a small-molecule inhibitor of mutated IDH1 enzymes. It specifically inhibits various R132 substitution mutations (including R132H, R132L, R132S, R132G, and R132C) without inhibiting wild-type IDH1 or mutated IDH2 proteins. By blocking these mutant enzymes, the drug reduces the accumulation of the oncometabolite 2-hydroxyglutarate (2-HG), thereby restoring normal cellular differentiation in leukemia cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-12-01
- Patent Cliff
- 2039
- Routes
- ORAL
- Dosage Forms
- CAPSULE
REZLIDHIA Approval History
What REZLIDHIA Treats
1 indicationsREZLIDHIA is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Myeloid Leukemia
REZLIDHIA Boxed Warning
DIFFERENTIATION SYNDROME Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution [see Warnings and Precautions ( 5.1 )] . WARNING: DIFFERENTIATION SYNDROME See full prescribing informat...
WARNING: DIFFERENTIATION SYNDROME Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution [see Warnings and Precautions ( 5.1 )] . WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate corticosteroids and hemodynamic monitoring until symptom resolution. ( 5.1 )
REZLIDHIA Target & Pathway
ProTarget
REZLIDHIA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in REZLIDHIA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications REZLIDHIA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to REZLIDHIA
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05564390 | NCI-2022-07006 NCI-2022-07006, MYELOMATCH | Ph 2 | recruiting | MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) |
| NCT07153497 | NCI-2025-06184 NCI-2025-06184, MM1OA-MDS-A05 | Ph 2 | not yet recruiting | Testing the Use of an IDH1 Inhibitor, Olutasidenib, in Acute Myeloid Leukemia Added to ASTX727 and Venetoclax; in High-Risk MDS Added to ASTX727; and Alone in Low Risk MDS (A MyeloMATCH Treatment Substudy) |
| NCT07411586 | 2025-1468 NCI-2026-01058 | Ph 1 | not yet recruiting | Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia |
| NCT06782542 OLUVENAZA | 20240763 | Ph 2 | recruiting | Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy |
| NCT07032727 | 2025-0520 NCI-2025-04331 | Ph 2 | recruiting | Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations |
| NCT06597734 | 2024-0515 NCI-2024-07758 | Ph 2 | withdrawn | 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 |
| NCT06445959 | 2024-0180 NCI-2024-04807 | Ph 1, Ph 2 | recruiting | Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib |
| NCT07486713 | C-002102-003 | Ph 4 | recruiting | Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies |
| NCT07471841 | HCRN-AML24-687 | Ph 2 | not yet recruiting | Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax |
| NCT07304011 | UCDCC320 NCI-2025-09023, UCDCC320 | Ph 2 | recruiting | Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent |
| NCT06543381 | 23483 NCI-2024-06471, 23483 | Ph 1 | recruiting | Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant |
| NCT06668584 | 2024-0522 NCI-2025-00104 | Ph 2 | recruiting | A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies |
| NCT06566742 | 2024-0509 NCI-2024-07045 | Ph 2 | recruiting | A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REZLIDHIA FDA Label Details
Indications & Usage
FDA Label (PDF)REZLIDHIA is indicated for the treatment of Acute Myeloid Leukemia.
WARNING: DIFFERENTIATION SYNDROME Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold R...
REZLIDHIA Patents & Exclusivity
Patents (14 active)
Exclusivity
Pro Intelligence Preview
Deep insights for REZLIDHIA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 14 active patents
Trial Analysis
- • 13 total trials
- • Stage: Growth
Competitive Landscape
- • 18 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment