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Ibsrela Approval History

FDA Approved: Yes (First approved September 12, 2019)
Brand name: Ibsrela
Generic name: tenapanor
Dosage form: Tablets
Company: Ardelyx, Inc
Treatment for: Irritable Bowel Syndrome

Ibsrela (tenapanor) is a first-in-class, sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

Development History and FDA Approval Process for Ibsrela

DateArticle
Sep 12, 2019Approval FDA Approves Ibsrela (tenapanor) for the Treatment of Irritable Bowel Syndrome with Constipation
Sep  3, 2019Ardelyx Announces Positive Results from the Pivotal Phase 3 AMPLIFY Study Evaluating Tenapanor in Dialysis Patients Who Have Uncontrolled Hyperphosphatemia Despite Phosphate Binder Treatment
Nov 13, 2018Ardelyx Announces FDA Acceptance of the Filing of its New Drug Application for Tenapanor for the Treatment of Patients with IBS-C
Sep 13, 2018Ardelyx Submits New Drug Application for Tenapanor for IBS-C
Jan  3, 2018Ardelyx Successfully Completes T3MPO-3 Safety Extension Study of Tenapanor for IBS-C
Oct 16, 2017Ardelyx Announces Tenapanor Reduces Pain Caused by IBS-C Through Inhibition of TRPV-1 Signaling
Oct 11, 2017Ardelyx's Pivotal Phase 3 Study of Tenapanor for IBS-C Hits Primary and All Secondary Endpoints to Support NDA Submission in 2018
May 19, 2015Ardelyx Presents Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C
May  5, 2015Ardelyx Reports Results from Phase 2a Clinical Trial Evaluating Tenapanor
Oct  1, 2014Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor

Further information

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