NDAORALTABLETPriority Review
Approved
Aug 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
17
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 6m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HERNEXEOS (zongertinib) is an oral small-molecule HER2/Neu antagonist kinase inhibitor approved August 2025 for the treatment of HER2-positive malignancies. It represents a targeted oncology approach designed to inhibit HER2 signaling pathways in cancer cells. The drug addresses unmet needs in patients with HER2-driven tumors seeking oral, convenient dosing.
Growth14.8 years to LOE
Early-stage growth product with significant upside potential; anticipate expanding commercial team investment and field infrastructure buildout over next 18–36 months.
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 (17)
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 People to Test How Zongertinib is Taken up in the Body When Given as Tablets Made by Two Different Manufacturers With or Without Food
Started Sep 2026
56 enrolled
Healthy
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
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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.