HYRNUO

LaunchSM

sevabertinib

NDAORALTABLETPriority Review
Approved
Nov 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
4

Mechanism of Action

2 (HER2). It also exhibits activity against epidermal growth factor receptor (EGFR). In vitro, sevabertinib inhibited the phosphorylation of HER2 and downstream signaling in cancer cells with HER2 alterations and proliferation of cancer cells overexpressing wild-type HER2 or harboring HER2…

Clinical Trials (4)

NCT07102095Phase 1Completed

A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose

Started Jul 2025
18 enrolled
Hepatic InsufficiencyLiver DiseasesPharmacokinetics+1 more
NCT06760819Phase 2Recruiting

A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Started Feb 2025
111 enrolled
Advanced Solid TumorsHER2 Mutation
NCT06452277Phase 3Recruiting

A Study to Learn More About How Well Sevabertinib (BAY 2927088) Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Started Aug 2024
278 enrolled
Advanced Non-small Cell Lung CancerHER2 Mutation
NCT06761976N/AAvailable

Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation

Advanced Non-small Cell Lung CancerCancer

Loss of Exclusivity

LOE Date
Oct 10, 2035
116 months away
Patent Expiry
Oct 10, 2035
Exclusivity Expiry
Nov 19, 2030

Patent Records (1)

Patent #ExpiryTypeUse Code
10428063
Oct 10, 2035
SubstanceProduct