NDAORALTABLETPriority Review
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
13
Mechanism of Action
HER2/Neu/cerbB2 Antagonists
Pharmacologic Class:
Kinase Inhibitor
Clinical Trials (5)
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
A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body
Started Jul 2024
16 enrolled
Healthy
Loss of Exclusivity
LOE Date
Jul 21, 2041
187 months away
Patent Expiry
Jul 21, 2041
Exclusivity Expiry
Aug 8, 2030