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Ensartinib - Betta Pharmaceuticals/Xcovery

Drug Profile

Ensartinib - Betta Pharmaceuticals/Xcovery

Alternative Names: Ensacove; Ensartinib Hydrochloride; X-396

Latest Information Update: 04 Jan 2023

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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

  • 30 Dec 2022 National Cancer Institute re-initiates the phase II Pediatric MATCH trial in Solid tumours, Non-Hodgkin's lymphoma and CNS cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater, In infants, In children, In adolescents, In adults) in USA and Puerto Rico (PO) (NCT03213652)
  • 27 Dec 2022 Xcovery Holding Company plans a phase I trial for Non Small Cell Lung Cancer (In healthy volunteers) (PO) (NCT05665283; XCV-X396-ONC-103)
  • 02 Nov 2022 National Cancer Institute suspends the phase II MATCH trial in Solid tumours, Non-Hodgkin's lymphoma and CNS cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater, In infants, In children, In adolescents, In adults) in USA and Puerto Rico due to drug supply issues (PO) (NCT03213652)
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