Drug Profile

Ponatinib - Incyte Corporation/Otsuka Pharmaceutical/Takeda

Alternative Names: AP-24534; AP24534 HCl; AP24534 hydrochloride; AP24534-HCL; Iclusig; Ponatinib hydrochloride

Latest Information Update: 16 May 2025

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At a glance

Originator ARIAD Pharmaceuticals
Developer Fundacion CRIS de Investigacion para Vencer el Cancer; Incyte Biosciences International; Incyte Corporation; Otsuka Beijing Research Institute; Otsuka Pharmaceutical; Takeda; University of Birmingham
Class Antineoplastics; Benzamides; Imidazoles; Piperazines; Pyridazines; Small molecules
Mechanism of Action Bcr-Abl tyrosine kinase inhibitors; Fibroblast growth factor receptor antagonists; Fms-like tyrosine kinase 3 inhibitors; Platelet-derived growth factor alpha receptor antagonists; Proto-oncogene protein c-kit inhibitors; Proto-oncogene protein c-ret inhibitors; Vascular endothelial growth factor receptor antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Precursor cell lymphoblastic leukaemia-lymphoma; Chronic myeloid leukaemia
New Molecular Entity Yes

Marketed Chronic myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
Phase I/II Acute myeloid leukaemia; Haematological malignancies; Solid tumours
Discontinued Gastrointestinal stromal tumours

25 Apr 2025 Takeda completes the phase II OPTIC trial in Chronic myeloid leukaemia (Second-line therapy or greater) in Argentina, Australia, Belgium, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Italy, Poland, Portugal, South Korea, Russia, Singapore, Spain, Sweden, Switzerland, Taiwan, US, UK (NCT02467270)
15 Jan 2025 Takeda terminates a phase-I/II clinical trials in Precursor cell lymphoblastic leukaemia-lymphoma (In adults, In children, In infants, In adolescents, Second-line therapy or greater) in United Kingdom, in the US, Argentina, Australia, Brazil, China, Czech Republic, France, Italy, South Korea, Mexico, Spain, Poland, Portugal and the Netherlands (PO) due to dose-limiting toxicities (NCT04501614) (EudraCT2019-002549-39)
03 Dec 2024 The FDA label for ponatinib carries a black box warning concerning incidences of vascular occlusion, venous thromboembolism, heart failure and hepatotoxicity with its use

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