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Ponatinib

Alternative Names: ponatinib, iclusig
Latest Update: 2024-12-12
Latest Update Note: Clinical Trial Update

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

Map of Global Clinical Trials for Ponatinib

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

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