An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 07 Nov 2017
At a glance
- Drugs Tenapanor (Primary)
- Indications Irritable bowel syndrome
- Focus Adverse reactions; Registrational
- Acronyms T3MPO-3
- Sponsors Ardelyx
- 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.
- 11 Oct 2017 According to an Ardelyx media release, the results of the trial will be included in the NDA submission for tenapanor for the treatment of patients with IBS-C.