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Ezabenlimab - Boehringer Ingelheim

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Drug Profile

Ezabenlimab - Boehringer Ingelheim

Alternative Names: BI-754091

Latest Information Update: 10 Jul 2025

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At a glance

  • Originator Boehringer Ingelheim
  • Developer Amal Therapeutics; Boehringer Ingelheim; National Health Research Institutes
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Anal cancer; Oesophageal cancer; Solid tumours; Squamous cell cancer
  • Phase I/II Colorectal cancer
  • Phase I Adenocarcinoma; Liver cancer; Neuroendocrine tumours; Non-small cell lung cancer; Small cell lung cancer
  • No development reported Head and neck cancer

Most Recent Events

  • 30 Apr 2025 OSE Immunotherapeutics completes a phase-I trial in Solid tumours in France and Belgium (NCT03990233)
  • 03 Dec 2024 Boehringer Ingelheim completes a phase-II trial in Solid tumours (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in the US, Canada, and the UK (IV) (NCT03697304),
  • 12 Sep 2024 Boehringer Ingelheim completes a phase Ib trial in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in Japan, Hong Kong, Russia, USA, Australia, France, Germany, Hong Kong, South Korea, Poland, Russia, Spain, Taiwan, Ukraine, the United Kingdom (IV) (NCT03468426)

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