Efficacy and safety trial of AJG533 in patients with chronic constipation (Phase 3 study)

Trial Profile

Efficacy and safety trial of AJG533 in patients with chronic constipation (Phase 3 study)

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jan 2018

At a glance

  • Drugs Elobixibat (Primary)
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Sponsors Albireo AB; EA Pharma
  • Most Recent Events

    • 19 Jan 2018 According to an Eisai Co media release, EA Pharma has obtained new drug approval for bile acid transporter inhibitor GOOFICE 5mg Tablet (nonproprietary name: elobixibat hydrate; development code: AJG533) for chronic constipation (excluding structural disease-induced constipation) in Japan. The approval was mainly based on the results from this trial.
    • 01 Feb 2017 According to Albireo Pharma media release, based on data from this trial EA Pharma Co. Ltd has submitted a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for elobixibat for the treatment of chronic constipation in Japan.
    • 03 Oct 2016 Results published in an Albireo media release.
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