Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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: 23 Sep 2026

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

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

Most Recent Events

  • 17 Sep 2026 According to a Novo Nordisk media release, based on the FRONTIER trial programme, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation for FREHEMGO (denecimig) to treat haemophilia A (HA), with or without inhibitors, in adults and children. The company expects to launch FREHEMGO in the first European countries in Q4 2026 and broadly across the EU starting early 2027.
  • 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.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top