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Phase III study of AJG511 in patients with active ulcerative colitis

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Trial Profile

Phase III study of AJG511 in patients with active ulcerative colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 2019

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At a glance

  • Drugs Budesonide (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Sponsors EA Pharma

Most Recent Events

  • 27 Sep 2017 Primary endpoint (Mucosal healing rates) has been met, according to a Kissei Pharmaceutical media release.
  • 27 Sep 2017 According to a Kessei Pharmaceuticals media release, EA Pharma has obtained marketing approval for "RECTABUL 2 mg Rectal Foam 14 Doses" for the treatment of ulcerative colitis in Japan. The approval was based on data from this trial.
  • 28 Oct 2016 Status changed from active, no longer recruiting to completed.

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