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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 - Gastric cancer; Pancreatic cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Gastric cancer; 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)
  • 08 Jan 2026 Updated efficacy and adverse events data from a phase II ILUSTRO trial in Oesophageal cancer presented at the 2026 Gastrointestinal Cancers Symposium (ASCO-GI-2026)
  • 08 Dec 2025 Launched for Gastric cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, First-line therapy) in Austria (IV)

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