Friday, July 10, 2026

Drug profile · INN

sevabertinib

sevabertinib (HYRNUO) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 1
Drug details — sevabertinib

Quick answer

sevabertinib (HYRNUO) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN sevabertinib
Brand HYRNUO
Route ORAL
Formulation TABLET

Approval history

Authority Status Date
FDA approved

Recent coverage

Pipeline programs

  1. Sevabertinib Phase 3 · Bayer HealthCare Animal · Advanced Non-small Cell Lung Cancer

Frequently asked questions

What is sevabertinib?

sevabertinib (HYRNUO) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for sevabertinib?

HYRNUO is a marketed brand name for sevabertinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of sevabertinib?

sevabertinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.