Drug Profile

Ponatinib - Incyte Corporation/Otsuka Pharmaceutical/Takeda

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

Latest Information Update: 15 Apr 2026

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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

27 Mar 2026 Preregistration for Precursor cell lymphoblastic leukaemia-lymphoma (First-line therapy, In adults) in Japan (PO)
06 Dec 2025 Adverse events and efficacy data from a phase II trial in Chronic myeloid leukemia presented at the 67th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2025)
25 Apr 2025 Efficacy and adverse events data from phase III PhALLCON trial in Acute lymphoblastic leukaemia presented at the 116th Annual Meeting of the American Association for Cancer Research (AACR-2025)

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