ICLUSIG

Peak

ponatinib hydrochloride

NDAORALTABLETPriority Review
Approved
Dec 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
13

Mechanism of Action

inhibitor. Ponatinib inhibited the in vitro tyrosine kinase activity of ABL and T315I mutant ABL with IC 50 concentrations of 0.4 nM and 2.0 nM, respectively. Ponatinib inhibited the in vitro activity of additional kinases with IC 50 concentrations between 0.1 nM and 20 nM, including members of the…

Clinical Trials (5)

NCT07224100Phase 2Recruiting

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
NCT04501614Phase 1/2Terminated

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)
NCT06945146N/ACompleted

Genomics Study in CML Patients With Ponatinib Treatment

Started Sep 2020
65 enrolled
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
NCT03589326Phase 3Active Not Recruiting

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)
NCT03709017N/AUnknown

Iclusig PMS in CML or Ph+ALL Patients

Started Aug 2018
50 enrolled
Chronic Myeloid LeukemiaPhiladelphia Chromosome-positive Acute Lymphoblastic Leukemia

Loss of Exclusivity

LOE Date
Dec 12, 2033
94 months away
Patent Expiry
Dec 12, 2033
Exclusivity Expiry
Mar 19, 2031

Patent Records (5)

Patent #ExpiryTypeUse Code
9029533
Dec 22, 2026
U-1699
8114874
Jan 24, 2027
SubstanceProduct
11192895
Dec 12, 2033
U-1948
11192897
Dec 12, 2033
Substance
U-1948
11384086
Dec 12, 2033
SubstanceProduct
U-1700