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Silmitasertib - Senhwa Biosciences

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Drug Profile

Silmitasertib - Senhwa Biosciences

Alternative Names: CX 4945

Latest Information Update: 23 Aug 2024

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At a glance

  • Originator Cylene Pharmaceuticals
  • Developer Cylene Pharmaceuticals; Penn State College of Medicine; Senhwa Biosciences; Stanford University School of Medicine
  • Class 3-ring heterocyclic compounds; Antineoplastics; Antivirals; Carboxylic acids; Naphthyridines; Small molecules
  • Mechanism of Action Casein kinase II inhibitors
  • Orphan Drug Status

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

    Yes - Cholangiocarcinoma; Biliary cancer; Medulloblastoma
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Community-acquired pneumonia; COVID 2019 infections
  • Phase I/II Cholangiocarcinoma; Medulloblastoma
  • Phase I Basal cell cancer
  • Preclinical Acute myeloid leukaemia; Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor T-cell lymphoblastic leukaemia-lymphoma
  • No development reported Giant lymph node hyperplasia; Multiple myeloma; Solid tumours

Most Recent Events

  • 09 Aug 2024 Senhwa Biosciences plans a phase I/II trial in Solid tumors (Second-line therapy, Children, Adolescents, Adults, Combination therapy) (PO) in September 2024 (NCT06541262)
  • 06 Aug 2024 Senhwa Biosciences receives "Study May Proceed" letter from the US FDA for the phase I/II trial in Solid tumors
  • 11 Jul 2024 Senhwa Biosciences announces intention to apply for Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPD) for Silmitasertib for Neuroblastoma

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