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Zolbetuximab - Astellas Pharma

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Drug Profile

Zolbetuximab - Astellas Pharma

Alternative Names: Anti-claudin 18.2 antibody - Astellas Pharma; Chimeric monoclonal antibody against claudin-18 splice variant 2 - Astellas Pharma; Claudiximab - Astellas Pharma; IMAB-362; VYLOY

Latest Information Update: 03 Apr 2025

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At a glance

  • Originator Ganymed Pharmaceuticals
  • Developer Astellas Pharma; Ganymed Pharmaceuticals
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity
  • Orphan Drug Status

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

    Yes - Pancreatic cancer; Gastric cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Gastric cancer
  • Registered Oesophageal cancer
  • Preregistration Pancreatic cancer

Most Recent Events

  • 03 Apr 2025 Astellas Pharma plans a phase III LUCERNA trial for Gastric cancer and Esophageal cancer (First line therapy, Combination therapy, Unresectable/Inoperable, Late stage disease, Metastatic disease) in (IV, Infusion) in April 2025 (NCT06901531) (EudraCT2024-519773-19)
  • 05 Jan 2025 Registered for Gastric cancer (First-line therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in China (IV)
  • 05 Jan 2025 Registered for Oesophageal cancer (Metastatic disease, Late-stage disease, Inoperable/Unresectable, First-line therapy) in China (IV)

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