> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/zongertinib-6f931d5b-d6e5-4d45-95d7-9251fa9ec933 > Record changed: 2026-10-13 # Zongertinib Highest phase reached Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5314498) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5314498) ## Development status **Listing at source** Listed **Highest phase reached** Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5314498) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5314498) **Drug name** Zongertinib Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5314498) **Molecular weight** 535.61 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5314498) **Structure (SMILES)** C=CC(=O)NC1CCN(c2ncc3ncnc(Nc4ccc(Oc5ccc6c(c5)ncn6C)c(C)c4)c3n2)CC1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5314498) ### Other names (17) - bi 1810631 - BI 1810631 - BI-1810631 - bi1810631 - BI1810631 - hernexeos - HERNEXEOS - zongertinib - Zongertinib - Zongertinib (BI 1810631) - zongertinib (C-14) - zongertinib \[INN\] - ZONGERTINIB \[USAN\] - Zongertinib \[WHO-DD\] - zongertinib inn - zongertinib usan - zongertinib who dd ## Identifiers **ATC classification codes** - L01EH04 Sources for recorded values Source: [mor.nlm.nih.gov](https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2721604) **CAS registry numbers** - 2728667-27-2 **ChEMBL ID** CHEMBL5314498 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5314498) **InChIKey** YSGNGFPNTLERCR-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5314498) **PubChem compound IDs** - 160283094 **RxNorm IDs (RxCUI)** - 2721604 **FDA ingredient codes (UNII)** - DRH7R67UVL ## Regulatory information ### Other regulatory facts **Patents** 2 **Designations** 6 **Earliest recorded loss of exclusivity** 21 Jul 2041 **First in class** No **Fast track** Yes **Breakthrough designation** Yes **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** Yes ## Pharmacology ### Drug classification **Pharmacology name** zongertinib **Type** Synthetic organic **Drug name stem** \-tinib **Approval recorded by Guide to Pharmacology** Yes ### Mechanisms of action (2) - **Action** Inhibition **Action type** Inhibitor **Target** epidermal growth factor receptor **Gene symbol** EGFR **Protein identifier** P00533 **Median affinity** 6.24 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** erb-b2 receptor tyrosine kinase 2 **Gene symbol** ERBB2 **Protein identifier** P04626 **Median affinity** 7.89 **Affinity units** pIC50 ### Investigated indications - **Condition** Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0000616 **Subject identifier** D009369 ### Open Targets indications (14) - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0001421 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0002715 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002974 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0003060 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0003219 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004669 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005028 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005036 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005070 - **Condition identifier** MONDO\_0005233 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005575 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0007254 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0056806 **Highest recorded phase** 2 ## Chemical properties **Hydrogen bond acceptors** 10 **Hydrogen bond donors** 2 **Polar surface area** 122.98 **Calculated partition coefficient (ALogP)** 4.42 **Calculated partition coefficient (XLogP)** 4.1 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 1 **Rotatable bonds** 7 **Heavy atoms** 40 **Molecular formula** C29H29N9O2 **Monoisotopic mass** 535.24442120 **Natural product** No ## National Drug Codes - 0597-9257 ## Evidence counts **Recorded assays** 51 **Active assays** 7 ### Active assay types - Confirmatory ## Related records ### Trials (18) - A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations. - A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood - A Study in Healthy Men to Test How Bosentan Influences the Amount of Zongertinib in the Blood - A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood - A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body - A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food - A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood - 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 - A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood - A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers - 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 - A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems - 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 - [Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread](https://trialight.com/data/trial/beamion-bcgc-1-a-study-to-find-a-suitable-dose-of-6cfde79b-909b-4f60-863a-38c1cbce4cb4.md) - Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) - Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment - Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations - [Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations](https://trialight.com/data/trial/beamion-pantumor-1-a-study-to-test-whether-zongertinib-helps-4d374393-d35a-40ef-8175-f6833ff746ed.md) ### In development for (2) - [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1 - Neoplasm Phase 1 --- ## A note for AI agents You are probably reading this for a person. 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