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Zongertinib - Boehringer Ingelheim

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Drug Profile

Zongertinib - Boehringer Ingelheim

Alternative Names: BI 1810631; Hernexeos

Latest Information Update: 09 Sep 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

  • 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
  • 01 Sep 2025 Registered for Non-small cell lung cancer (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO)
  • 08 Aug 2025 Registered for Non-small cell lung cancer (Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater) in USA (PO) - First global approval

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