NDAORALCAPSULE
Approved
Dec 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9
Data completeness
5/8 — Partial
REZLIDHIA (olutasidenib) by Rigel Pharmaceuticals. Approved for acute myeloid leukemia, myelodysplastic syndrome. First approved in 2022.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REZLIDHIA (olutasidenib) is an oral capsule medication approved by the FDA on December 1, 2022, manufactured by Rigel Pharmaceuticals. Data regarding its mechanism of action, pharmacologic class, and specific indications are not available in this dataset. The product is currently in the peak lifecycle stage, indicating it has recently launched and is in active commercial development.
$0.0BPart D
13.5 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (2)
Clinical Trials (9)
Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
Started May 2026
25 enrolled
IDH1 MutationRelapsed / Refractory AML
Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy
Started Mar 2026
16 enrolled
Acute Myeloid LeukemiaIDH1 Mutation
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
Started Feb 2026
16 enrolled
AML (Acute Myeloid Leukemia)GliomaCholangiocarcinoma+1 more
Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation
Started Feb 2026
15 enrolled
Acute Myeloid Leukemia
Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations
Started Sep 2025
68 enrolled
Targeted TherapyIDH1-Mutated MalignanciesMutations
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.