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Ensartinib - Betta Pharmaceuticals/Xcovery

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Drug Profile

Ensartinib - Betta Pharmaceuticals/Xcovery

Alternative Names: Ensacove; Ensartinib Hydrochloride; X-396

Latest Information Update: 18 Mar 2024

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At a glance

  • Originator Xcovery
  • Developer AstraZeneca; Betta Pharmaceuticals Co Ltd; Cancer Research Institute; Ludwig Institute for Cancer Research; Memorial Sloan-Kettering Cancer Center; National Cancer Institute (USA); Xcovery Holdings
  • Class Antineoplastics; Piperazines; Pyridazines; Small molecules
  • Mechanism of Action Anaplastic lymphoma kinase inhibitors; EphA2 receptor antagonists; Proto-oncogene protein c-met inhibitors; ROS1 protein inhibitors; TrkA receptor antagonists; TrkC receptor antagonists
  • 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

  • Marketed Non-small cell lung cancer
  • Phase II CNS cancer; Malignant melanoma; Non-Hodgkin's lymphoma; Solid tumours

Most Recent Events

  • 14 Mar 2024 US FDA accepts NDA for ensartinib for ALK-positive non-small cell lung cancer (NSCLC) for review
  • 13 Mar 2024 FDA assigns PDUFA action date of 28/12/2024 for ensartinib for metastatic ALK-positive non-small cell lung cancer
  • 12 Dec 2023 Phase-II clinical trials in Non-small cell lung cancer (Metastatic disease, Late-stage disease, Recurrent, Second-line therapy or greater) (PO) (NCT03753685)
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