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Open-label, Long-term Safety and Efficacy Study of Mim8 in Participants With Haemophilia A With or Without Inhibitors

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Trial Profile

Open-label, Long-term Safety and Efficacy Study of Mim8 in Participants With Haemophilia A With or Without Inhibitors

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Feb 2026

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At a glance

  • Drugs Denecimig (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; Registrational
  • Acronyms FRONTIER 4
  • Sponsors Novo Nordisk

Most Recent Events

  • 02 Oct 2025 Planned End Date changed from 31 Dec 2030 to 30 Jun 2028.
  • 02 Oct 2025 Planned primary completion date changed from 31 Dec 2030 to 30 Jun 2028.
  • 29 Sep 2025 According to Novo Nordisk media release, based on the data from the trial company submitted for review to the US Food and Drug Administration (FDA) through a Biologics License Application (BLA).

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