Drug Profile

Zongertinib - Boehringer Ingelheim

Alternative Names: BI 1810631; HER2 exon 20 inhibitor

Latest Information Update: 07 May 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

28 Apr 2025 Efficacy and adverse events data from a phase Ib Beamion LUNG-1 trial in Non-small cell lung cancer released by Boehringer Ingelheim
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)

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