Product Description
Oral ponatinib (Iclusig(®)) is a novel kinase inhibitor structurally designed with a carbon-carbon triple bond to accommodate the T315I mutation in the ABL kinase domain. It has demonstrated inhibitory activity against native BCR-ABL tyrosine kinase and a variety of BCR-ABL mutants, including T315I. Ponatinib is approved for the treatment of adults with T315I-positive chronic-, accelerated- or blast-phase chronic myeloid leukaemia (CML), or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukaemia (ALL) [in the EU and the USA], as well as those with chronic-, accelerated- or blast-phase CML, or Ph+ ALL who are resistant or intolerant to prior tyrosine kinase inhibitor therapy (EU) or for whom no other tyrosine kinase inhibitor therapy is indicated (USA). (Sourced from: https://pubmed.ncbi.nlm.nih.gov/24807266/)
Mechanisms of Action: FGFR1 Inhibitor,TK Inhibitor,Bcr-Abl Inhibitor,PGFR Antagonist,VEGFR Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: Acute Leukemia | Acute Lymphoid Leukemia | Acute Myeloid Leukemia | Chronic Leukemia | Chronic Lymphoid Leukemia | Chronic Myeloid Leukemia | Leukemia | Lymphoid Leukemia | Myeloid Leukemia | Myeloid, Accelerated Leukemia
Known Adverse Events: Hypertension | Abdominal Pain | Headache | Labor Pain | Pain Unspecified | Pancreatitis | Anemia | Arthralgia | Skin Abnormalities | Constipation | Edema
Company: Takeda
Company Location: TOKYO M0 103-8668
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Romania, Russia, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 22
Highest Development Phases
Phase 3: Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma
Phase 2: Acute Myeloid Leukemia|Blast Crisis|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|Gastrointestinal Stromal Tumors|Leukemia|Lymphoma|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Myeloid, Accelerated Leukemia
Phase 1: Depressive Disorder
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
2019-002549-39 | P2 |
Unknown status |
Acute Lymphoid Leukemia |
2027-12-07 |
|
jRCT2031210230 | P3 |
Recruiting |
Acute Lymphoid Leukemia |
2027-07-31 |
|
TIPI | P2 |
Active, not recruiting |
Chronic Myeloid Leukemia |
2027-07-09 |
|
ALL2820 | P3 |
Active, not recruiting |
Acute Lymphoid Leukemia |
2027-07-07 |