NDAORALTABLETPriority Review
Approved
Dec 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
14
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ICLUSIG (ponatinib hydrochloride) is an oral small-molecule tyrosine kinase inhibitor approved by the FDA in December 2012 for treating acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). The drug mechanism of action and specific pharmacologic class data are not available in this profile. ICLUSIG represents a targeted therapy approach for hematologic malignancies with limited therapeutic alternatives.
$0.1BPart D
7.6 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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma
Started Mar 2026
33 enrolled
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1B Lymphoblastic Leukemia/Lymphoma With t(9;22)(q34.1;q11.2); BCR-ABL1Lymphoblastic Lymphoma
A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Started Feb 2021
11 enrolled
Pediatric Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL)Ph+ Mixed Phenotype Acute Leukemia (MPAL)Philadelphia Chromosome-Like ALL (Ph-like ALL)
Genomics Study in CML Patients With Ponatinib Treatment
Started Sep 2020
65 enrolled
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
Started Oct 2018
245 enrolled
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
Iclusig PMS in CML or Ph+ALL Patients
Started Aug 2018
50 enrolled
Chronic Myeloid LeukemiaPhiladelphia Chromosome-positive Acute Lymphoblastic 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.