NDAORALTABLETPriority Review
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
15
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 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HERNEXEOS (zongertinib) is an oral small-molecule kinase inhibitor targeting HER2/Neu/cerbB2, approved August 2025 by the FDA. It represents a new treatment option in the growing class of HER2-directed therapies for oncology indications. The drug's mechanism targets aberrant HER2 signaling, a well-validated pathway in solid tumors.
Launch15.1 years to LOE
Early-stage launch product with significant growth potential; newly approved oral kinase inhibitor entering a competitive but established market, likely requiring full commercial infrastructure build-out.
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 (15)
A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.
Started Oct 2026
25 enrolled
Advanced Breast CancerHormone Receptor Positive / HER2-negative Breast CancerHER2 Mutation
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 Jun 2026
60 enrolled
Lung Cancer, Non-squamous, Non-small Cell
Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
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
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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.