NDAORALTABLETPriority Review
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
16
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 6h ago · AI intelligence enriched 1mo 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.
Launch15.0 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 (16)
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
A Study in Healthy Men to Test How Bosentan Influences the Amount of Zongertinib in the Blood
Started Jun 2026
16 enrolled
Healthy
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
Worked on HERNEXEOS at Boehringer Ingelheim? Share your interview experience or compensation data (+7 days Pro)
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.