NDAORALTABLETPriority Review
Approved
Nov 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
5/8 — Partial
Priority Review
HYRNUO (sevabertinib) by Bayer is 2 (her2). First approved in 2025.
Drug data last refreshed 6h ago · AI intelligence enriched 13h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HYRNUO (sevabertinib) is an oral small-molecule tyrosine kinase inhibitor targeting HER2 and EGFR, designed to treat non-small cell lung cancer (NSCLC) harboring HER2 exon 20 mutations. The drug inhibits HER2 and EGFR phosphorylation and downstream signaling, demonstrating antitumor activity in preclinical models of HER2-mutant NSCLC.
Launch17.1 years to LOE
Newly launched product with zero competitive pressure, positioning Bayer for early market capture in a focused HER2-mutant NSCLC segment with room for commercial team expansion.
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…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Phase 1 Study in Healthy Adults to See How Sevabertinib Changes Metformin Levels in the Body
Started Aug 2026
40 enrolled
Healthy Participants
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
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
A Study to Learn More About How Well Sevabertinib 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
444 enrolled
Advanced Non-small Cell Lung Cancer, HER2 Mutation
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.