NDAORALTABLETPriority Review
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
14
Data completeness
6/8 — Strong
Priority Review
HERNEXEOS (zongertinib) by Boehringer Ingelheim is her2/neu/cerbb2 antagonists [moa]. Approved for kinase inhibitor [epc]. First approved in 2025.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HERNEXEOS (zongertinib) is an oral small-molecule HER2/Neu kinase inhibitor approved in August 2025 for non-small cell lung cancer (NSCLC). It represents a targeted therapy approach for patients whose tumors express HER2 mutations or alterations. The drug works by antagonizing HER2 signaling, a key driver of cancer cell proliferation in susceptible NSCLC populations.
Growth15.2 years to LOE
As a newly launched product in an underserved HER2-NSCLC segment, HERNEXEOS will require significant commercial investment in market education, HCP engagement, and patient identification during its first 18–24 months post-approval.
Mechanism of Action
HER2/Neu/cerbB2 Antagonists
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab
Started May 2026
60 enrolled
Lung Cancer, Non-squamous, Non-small Cell
Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
Started Jan 2026
400 enrolled
Non-small Cell Lung Cancer
A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems
Started Jan 2025
29 enrolled
Liver DiseasesHealthy
Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
Started Oct 2024
430 enrolled
Solid Tumours
A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood
Started Aug 2024
32 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.