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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: 19 Feb 2026

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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

  • 04 Feb 2026 Discontinued - Phase-II for Pancreatic cancer (Combination therapy, First-line therapy, Metastatic disease) in USA, Brazil, Spain, Ireland, Japan, Taiwan, Australia, France, Italy, South Korea, Turkey, China and Mexico due to lack of efficacy (IV) (Astellas Pharma, February 2026)
  • 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)

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