Ponatinib hydrochloride is under clinical development by Takeda Pharmaceutical and currently in Phase II for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia). According to GlobalData, Phase II drugs for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Ponatinib hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Ponatinib hydrochloride overview

Ponatinib (Iclusig) is an antimetabolite agent. It is formulated as film coated tablets  and coated tablets for oral route of administration. Iclusig is indicated for the treatment of adult patients with T315I-positive chronic myeloid leukemia  (CML) (chronic phase, accelerated  phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated. Iclusig is indicated for the treatment of adult patients with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. 

The drug candidate is under development for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia, pulmonary tumor thrombtic microangiopathy, acute myelocytic leukemia (AML, acute myeloblastic leukemia), acute lymphocytic leukemia (ALL), advanced biliary cancer, lung cancer, second-line patients with chronic-phase chronic myeloid leukemia, and pediatric patients with chronic myeloid leukemia (second line), acute myeloid leukemia (second line), acute lymphocytic leukemia (second line and third line), lymphoma (second line), solid tumors including central nervous system (second line) tumors. It was also under development for medullary thyroid cancer, myelodysplastic syndrome, refractory metastatic unresectable gastrointestinal stromal tumors (GIST) and refractory glioblastoma.

Takeda Pharmaceutical overview

Takeda Pharmaceutical (Takeda) is a research-based pharmaceutical company, which focuses on the discovery, development, manufacturing, marketing, commercialization, import and export of drugs. It provides treatment for inflammatory bowel disease, acid-related diseases, motility disorders and liver diseases; hemophilia and hereditary bleeding disorders; primary immunodeficiency and multifocal motor neuropathy; major depressive disorder and attention-deficit hyperactivity disorder; and its cancer treatment encompasses multiple myeloma, mantle cell lymphoma, non-small cell lung cancer and chronic myeloid leukemia. It markets products directly and through a network of wholesale distributors, retail chains and other purchasing groups worldwide. Takeda has partnership with academic institutions, small biotech, and large pharmaceutical companies. It has presence in the Americas, Europe, and Asia, among others. Takeda is headquartered in Tokyo, Japan.

For a complete picture of Ponatinib hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 May 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.