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Poziotinib - Hanmi Pharmaceutical

Drug Profile

Poziotinib - Hanmi Pharmaceutical

Alternative Names: 14C-labeled poziotinib; HM-781-36B; NOV-120101

Latest Information Update: 01 Feb 2019

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At a glance

  • Originator Hanmi Pharmaceutical
  • Developer Chonnam National University Hospital; Chungnam National University; Hanmi Pharmaceutical; Konkuk University Medical Center; Korean Association for the Study of Targeted Therapys; Kosin University Gospel Hospital; Kyungpook National University Medical School; Spectrum Pharmaceuticals; University of Texas M. D. Anderson Cancer Center; Yonsei University Health System
  • Class Anilinouracils; Antineoplastics; Piperidines; Quinazolines; Small molecules
  • Mechanism of Action Epidermal growth factor receptor antagonists; ERBB 2 receptor antagonists; ERBB 4 receptor antagonists; Protein tyrosine kinase inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Breast cancer; Gastric cancer; Head and neck cancer; Lung cancer; Non-small cell lung cancer
  • No development reported Colorectal cancer

Most Recent Events

  • 01 Feb 2019 Spectrum Pharmaceuticals plans a phase I trial for Solid tumours in March 2019 (NCT03804515)
  • 02 Jan 2019 Phase-II clinical trials in Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in Canada (PO) before January 2019
  • 19 Dec 2018 Poziotinib did not receive Breakthrough therapy designation from US FDA for Non-small cell lung cancer
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