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| Trade names | Hernexeos |
| Other names | BI-1810631, BI1810631 |
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| Routes of administration | By mouth |
| Drug class | Antineoplastic,epidermal growth factor receptor 2 (HER2) inhibitor |
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| Formula | C29H29N9O2 |
| Molar mass | 535.612 g·mol−1 |
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Zongertinib, sold under the brand nameHernexeos, is ananti-cancer medication used for the treatment ofnon-small cell lung cancer.[1][2] Zongertinib is a kinase inhibitor of humanepidermal growth factor receptor 2 (HER2).[1][3][4] It is takenby mouth.[1]
Zongertinib was approved for medical use in the United States in August 2025.[5]
Zongertinib isindicated for the treatment of adults with unresectable or metastatic non-squamousnon-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.[1][5]
The USFood and Drug Administration prescribing information includes warnings and precautions for hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.[1][5]
Efficacy was evaluated in participants with unresectable or metastatic, non-squamous non-small cell lung cancer with HER2 (ERBB2) TKD mutations who had received prior systemic therapy and received zongertinib in Beamion LUNG-1 (NCT04886804), an open-label, multi-center, multi-cohort trial.[5] The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) determined by blinded independent central review per RECIST v1.1.[5]
The USFood and Drug Administration granted the application for zongertinibpriority review,breakthrough therapy, andfast track designations.[5]
Zongertinib was approved for medical use in the United States in August 2025.[2][6]
Zongertinib is theinternational nonproprietary name[7] and theUnited States Adopted Name.[8]
Zongertinib is sold under the brand name Hernexeos.[2][6]
This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain.