🇺🇸 Hernexeos in United States

FDA authorised Hernexeos on 8 August 2025

Marketing authorisations

FDA — authorised 8 August 2025

  • Application: NDA219042
  • Marketing authorisation holder: BOEHRINGER INGELHEIM
  • Local brand name: HERNEXEOS
  • Indication: TABLET — ORAL
  • Status: approved

The FDA approved Hernexeos, a drug developed by Boehringer Ingelheim, for its approved indication on 26 February 2026. The application number for this approval is NDA219042. Hernexeos was granted marketing authorisation through the standard expedited pathway.

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FDA

  • Marketing authorisation holder: BOEHRINGER INGELHEIM
  • Status: approved

Hernexeos in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Hernexeos approved in United States?

Yes. FDA authorised it on 8 August 2025; FDA has authorised it.

Who is the marketing authorisation holder for Hernexeos in United States?

BOEHRINGER INGELHEIM holds the US marketing authorisation.