An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Trial Profile

An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2018

At a glance

  • Drugs Tenapanor (Primary)
  • Indications Irritable bowel syndrome
  • Focus Adverse reactions; Registrational
  • Acronyms T3MPO-3
  • Sponsors Ardelyx
  • Most Recent Events

    • 03 Jan 2018 Status changed from active, no longer recruiting to completed according to an Ardelyx media release.
    • 07 Nov 2017 According to an Ardelyx media release, the company expects to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the second half of 2018 seeking marketing authorization for tenapanor in IBS-C.
    • 07 Nov 2017 According to an Ardelyx media release, the company is on track to conclude this trial by the end of 2017.
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