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Zongertinib - Boehringer Ingelheim

Drug Profile

Zongertinib - Boehringer Ingelheim

Alternative Names: BI 1810631; Hernexeos

Latest Information Update: 17 Nov 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

  • 07 Nov 2025 Preregistration for Non-small cell lung cancer (First-line therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA (PO)
  • 07 Nov 2025 Zongertinib receives Commissioner's National Priority Voucher for Non-small cell lung cancer (First-line therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA
  • 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

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