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

Highest Development Phases

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

Most Recent Events

  • 22 May 2025 Astellas Pharma initiates phase-III LUCERNA trial for Adenocarcinoma (First line therapy, Combination therapy, Unresectable/Inoperable, Late stage disease, Metastatic disease) in positive and programmed death-ligand 1 (PD-L1) positive (NCT06901531; 8951-CL-0305; 2024-519773-19; jRCT2031250021) The randomised, double blind trial intends to enrol 500 participants in Australia, Belgium, China, France, Germany, Italy, Japan, Lithuania, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Taiwan, United Kingdom, USA (IV, Infusion) (NCT06901531) (EudraCT2024-519773-19)
  • 03 Apr 2025 Astellas Pharma plans a phase III LUCERNA trial for Adenocarcinoma (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)

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