Trial Profile

A Multinational, Open-label, Randomised, Controlled Study to Investigate Efficacy and Safety of NNC0365-3769 (Mim8) in Adults and Adolescents With Haemophilia A With or Without Inhibitors

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 08 May 2026

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At a glance

Drugs Denecimig (Primary)
Indications Haemophilia A
Focus Registrational; Therapeutic Use
Acronyms FRONTIER 2
Sponsors Novo Nordisk

Most Recent Events

29 Apr 2026 According to Novo Nordisk media release, the results from the trial were published in the New England Journal of Medicine (NEJM).
29 Apr 2026 Results presented in the Novo Nordisk media release.
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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