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Ibsrela FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 8, 2019.

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 timeline for Ibsrela

Sep 12, 2019Approval FDA Approves Ibsrela (tenapanor) for the Treatment of Irritable Bowel Syndrome with Constipation
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

Further information

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