NDAORALTABLETPriority Review
Approved
Dec 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ICLUSIG (ponatinib hydrochloride) is an oral small-molecule tyrosine kinase inhibitor approved in 2012 for chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It targets BCR-ABL1 and multiple other kinases, designed to overcome resistance to prior TKI therapy in patients with resistant or intolerant disease.
$123MPart D
PeakStable
7.5 years to LOEICLUSIG remains in peak commercial phase with $123M in Part D spending (2023) and 5,760 claims, indicating sustained market presence with established team structure.
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 (5)
Iclusig PMS in CML or Ph+ALL Patients
Started Aug 2018
50 enrolled
Chronic Myeloid LeukemiaPhiladelphia Chromosome-positive Acute Lymphoblastic Leukemia
An Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With ICLUSIG®
Started Mar 2018
3 enrolled
Myeloid Leukemia, Chronic-Phase, Accelerated-Phase, Blast-Phase, Ph+ALL
Observational Study on CML Patients in Any Phase of the Disease Treated With Ponatinib (Iclusig®)
Started Feb 2018
120 enrolled
Chronic Myeloid Leukemia
Iclusig® (Ponatinib) in Clinical Practice for the Treatment of Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium
Started Feb 2017
80 enrolled
Chronic Myeloid LeukemiaCMLPhiladelphia Chromosome-positive Acute Lymphoblastic Leukemia+1 more
A Phase 2 Trial of Ponatinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor
Started Jun 2013
45 enrolled
GIST
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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.