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Zongertinib - Boehringer Ingelheim

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Drug Profile

Zongertinib - Boehringer Ingelheim

Alternative Names: BI 1810631; HER2 exon 20 inhibitor

Latest Information Update: 16 Apr 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Non-small cell lung cancer
  • Phase II Solid tumours
  • Phase I/II Gastric cancer; HER2 positive breast cancer; Oesophageal cancer

Most Recent Events

  • 02 Apr 2025 Boehringer Ingelheim plans to launch zongertinib in the US, in second half of 2025
  • 19 Feb 2025 Preregistration for Non-small cell lung cancer (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (PO)
  • 19 Feb 2025 FDA assigns PDUFA action date of third quarter of 2025 for zongertinib for Non-small cell lung cancer

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