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Poziotinib - Hanmi Pharmaceutical/Assertio Therapeutics

Drug Profile

Poziotinib - Hanmi Pharmaceutical/Assertio Therapeutics

Alternative Names: HM-781-36; HM-781-36B; HM-781-36B hydrochloride; NOV-1201; NOV-120101; Poziotinib hydrochloride - Hanmi Phamaceutical/Assertio Therapeutics

Latest Information Update: 09 Feb 2024

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At a glance

  • Originator Hanmi Pharmaceutical
  • Developer Assertio Therapeutics; 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
  • Orphan Drug Status

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

  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Non-small cell lung cancer
  • Phase II Colorectal cancer; Gastric cancer; Glioma; Head and neck cancer; HER2 positive breast cancer; Lung cancer; Solid tumours

Most Recent Events

  • 26 Jan 2024 Spectrum Pharmaceuticals terminates the POZITIVE20-1 phase II trial in Non-small cell lung cancer (Late-stage disease, Metastatic disease, First-line therapy, Second-line therapy or greater) in USA, Belgium, Canada, France, Italy, Israel, Netherlands, Spain (PO) due to strategic business decision (NCT03318939) (EudraCT2018-001868-36)
  • 20 Oct 2023 Pharmacodynamics data from a phase II trials in Non-small cell lung cancer presented at the 48th European Society for Medical Oncology Congress (ESMO-2023)
  • 09 Sep 2023 Efficacy and adverse events data from the phase II ZENITH20 trial in Non-small cell lung cancer presented at the 24th World Conference on Lung Cancer (WCLC-2023)
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