Sevabertinib

Sevabertinib, sold under the brand name Hyrnuo, is an anti-cancer medication used for the treatment of non-small cell lung cancer.^[1] Sevabertinib is a kinase inhibitor.^[1] It is taken by mouth.^[1]

Sevabertinib

Clinical data
Trade names	Hyrnuo
Other names	BAY2927088, sevabertinib hydrate (JAN JP)
License data	US DailyMed: Sevabertinib
Routes of administration	By mouth
Drug class	Antineoplastic
ATC code	None
Legal status
Legal status	US: ℞-only[1]
Identifiers
CAS Number	2521285-05-0
PubChem CID	155234713
DrugBank	DB21667
ChemSpider	129786615
UNII	2A7VPM5RWH
KEGG	D13098
Chemical and physical data
Formula	C24H25ClN4O5
Molar mass	484.94 g·mol−1
3D model (JSmol)	Interactive image
SMILES COC1=C(C=CC=C1Cl)NC2=C(NC3=C2C(=O)NCC3)C4=C(C=NC=C4)OC[C@@H]5COCCO5
InChI InChI=InChI=1S/C24H25ClN4O5/c1-31-23-16(25)3-2-4-18(23)29-22-20-17(6-8-27-24(20)30)28-21(22)15-5-7-26-11-19(15)34-13-14-12-32-9-10-33-14/h2-5,7,11,14,28-29H,6,8-10,12-13H2,1H3,(H,27,30)/t14-/m0/s1 Key:VYQVHWNNPKOJEA-AWEZNQCLSA-N

Sevabertinib was approved for medical use in the United States in November 2025.^[2]

Medical uses

Sevabertinib is indicated for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations.^[1][2]

Adverse effects

The US prescribing information includes warnings and precautions for diarrhea, hepatotoxicity, interstitial lung disease/pneumonitis, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity.^[2]

History

Efficacy was evaluated in people with unresectable or metastatic, non-squamous non-small cell lung cancer with HER2 (ERBB2) tyrosine kinase domain activating mutations who had received prior systemic therapy and received sevabertinib in SOHO-01 (NCT05099172), an open-label, single-arm, multi-center, multi-cohort clinical trial.^[2] HER2 (ERBB2) activating mutations were determined in tumor tissue or plasma by local laboratories prior to enrollment.^[2]

The US Food and Drug Administration granted the application for sevabertinib priority review, breakthrough therapy, and orphan drug designations.^[2]

Society and culture

Legal status

Sevabertinib was approved for medical use in the United States in November 2025.^[3][4]

Names

Sevabertinib is the international nonproprietary name.^[5]

Sevabertinib is sold under the brand name Hyrnuo.^[1][3]