NDAORALCAPSULE
Approved
Dec 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
4/8 — Partial
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REZLIDHIA (olutasidenib) is an oral capsule small molecule approved in December 2022 by Rigel Pharmaceuticals. The specific indication and mechanism of action are not detailed in available data, but the product is positioned in the peak lifecycle stage. Patient population and therapeutic mechanism require additional clinical documentation for complete assessment.
$7MPart D
Peak13.4 years to LOEEarly commercial traction with modest Medicare utilization (229 claims, $7M spend in 2023) suggests small specialty market; brand team likely lean but growing as indication awareness increases.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia
Started Jun 2026
3 enrolled
Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia
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
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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.