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zongertinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tyrosine kinase inhibitors | 5781 | 2728667-27-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Zongertinib is a kinase inhibitor that selectively inhibits human epidermal growth factor receptor 2 (HER2). In vitro, zongertinib inhibited phosphorylation of HER2, downstream signaling of HER2 (phosphorylation of ERK), and proliferation of lung cancer cells harboring HER2 tyrosine kinase domain activating mutations. In vivo, zongertinib demonstrated anti-tumor activity in mouse xenograft models of NSCLC harboring HER2 tyrosine kinase domain activating mutations.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 8, 2025 | FDA | Boehringer Ingelheim | |
| Sept. 19, 2025 | PMDA | Nippon Boehringer Ingelheim Co., Ltd. |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01EH04 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors |
| FDA MoA | N0000020008 | HER2/Neu/cerbB2 Antagonists |
| MeSH PA | D000092004 | Tyrosine Kinase Inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D047428 | Protein Kinase Inhibitors |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Related Drugs by ATC class:
L01EH Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Non-squamous non-small cell lung cancer (NSCLC) | indication | 254637007 | DOID:3908 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 60MG | HERNEXEOS | BOEHRINGER INGELHEIM | N219042 | Aug. 8, 2025 | RX | TABLET | ORAL | 11608343 | July 21, 2041 | USE OF ZONGERTINIB FOR TREATING NON-SMALL CELL LUNG CANCER (NSCLC) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 60MG | HERNEXEOS | BOEHRINGER INGELHEIM | N219042 | Aug. 8, 2025 | RX | TABLET | ORAL | Aug. 8, 2030 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Receptor tyrosine-protein kinase erbB-2 | Kinase | INHIBITOR | IC50 | 8.15 | DRUG LABEL | DRUG LABEL | |||
| Epidermal growth factor receptor | Kinase | INHIBITOR | IC50 | 6.24 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| CHEMBL5314498 | ChEMBL_ID |
| C000731876 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4044179 | VANDF |
| C5855302 | UMLSCUI |
| CHEBI:759202 | CHEBI |
| 12474 | INN_ID |
| D12879 | KEGG_DRUG |
| 160283094 | PUBCHEM_CID |
| 396984 | MMSL |
| 42769 | MMSL |
| d10182 | MMSL |
| 020191 | NDDF |
| 12387 | IUPHAR_LIGAND_ID |
| DRH7R67UVL | UNII |
| 2721604 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| HERNEXEOS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0597-9257 | TABLET, FILM COATED | 60 mg | ORAL | NDA | 31 sections |