Efficacy and safety trial of AJG533 in patients with chronic constipation (Phase 3 study)
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History