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Zenocutuzumab - Merus

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Drug Profile

Zenocutuzumab - Merus

Alternative Names: BIZENGRI; HER3 x HER2 Biclonics®; MCLA-128; Zeno; Zenocutuzomab - Merus; zenocutuzumab-zbco - Merus

Latest Information Update: 04 Nov 2025

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At a glance

  • Originator Merus
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; ERBB 2 receptor antagonists; ERBB-3 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.

    Yes - Pancreatic cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Adenocarcinoma; Non-small cell lung cancer
  • Phase II HER2 positive breast cancer; Prostate cancer
  • Phase I/II Solid tumours
  • Preclinical Cancer

Most Recent Events

  • 04 Nov 2025 Zenocutuzumab - Merus receives Breakthrough Therapy status for Cholangiocarcinoma (Late-stage disease, Inoperable/Unresectable, Metastatic disease) in USA
  • 23 Oct 2025 Partner Therapeutics plans to submit supplemental Biologics License Application (sBLA) to FDA in 2026
  • 23 Oct 2025 Updated efficacy, adverse events and pharmacokinetic data from the phase I/II eNRGy trial in Solid tumours released by Merus

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