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Zongertinib - Boehringer Ingelheim

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Drug Profile

Zongertinib - Boehringer Ingelheim

Alternative Names: BI 1810631; Hernexeos

Latest Information Update: 27 Oct 2025

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At a glance

  • Originator Boehringer Ingelheim
  • Class Amides; Antineoplastics; Benzimidazoles; Piperidines; Pyrimidines; Small molecules
  • Mechanism of Action ERBB 2 receptor antagonists
  • Orphan Drug Status

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

    Yes - Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 17 Oct 2025 Updated efficacy and adverse events data from the phase Ib Beamion LUNG-1 trial in Non-small cell lung cancer released by Boehringer Ingelheim
  • 29 Sep 2025 Boehringer Ingelheim plans a phase III Beamion LUNG-3 trial for Non-small cell lung cancer (Early stage disease, Adjuvant therapy) in the US, Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Romania, South Korea, Spain, Sweden, Taiwan, and Turkey in December 2025 (NCT07195695).
  • 03 Sep 2025 Zongertinib - Boehringer Ingelheim receives Breakthrough Therapy status for Non-small cell lung cancer (First-line therapy, Metastatic disease, Inoperable/Unresectable, In adults) in USA

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