A pivotal Phase III trial of GALE-401 in patients with essential thrombocythemia

Trial Profile

A pivotal Phase III trial of GALE-401 in patients with essential thrombocythemia

Planning
Phase of Trial: Phase III

Latest Information Update: 11 Sep 2017

At a glance

  • Drugs Anagrelide (Primary)
  • Indications Essential thrombocythaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Galena Biopharma
  • Most Recent Events

    • 11 Sep 2017 According to a Galena Biopharma and BioVascular media release, both Galena Biopharma and BioVascular are responsible for the further development of GALE-401 (Phase 3-ready asset) drug for essential thrombocythemia.
    • 15 Mar 2017 According to a Galena Biopharma media release, after the meeting US FDA confirmed that the GALE-401 development program is appropriate for a NDA filing using the 505(b)(2) regulatory pathway in patients with essential thrombocythemia who are intolerant or resistant to hydroxyurea.
    • 09 Nov 2016 According to a Galena Biopharma media release, company expects to initiate this trial in the second quarter of 2017.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top