Tenapanor History and Updates

70 events · 2015 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: August 13, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-08Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Tenapanor since 2015, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completionSep 1, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05643534

Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06460038

Tenapanor in Synucleinopathy-Related Constipation

Primary completionFeb 26, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT07382167

A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults

Primary completionJul 31, 2031· ClinicalTrials.gov

Phase 3 primary completion: NCT05905926

Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Past events

2026

Primary completionJul 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06553547

4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06810167

Assessing Tenapanor as a Treatment of CF-related Constipation.

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06553547

4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

Primary completionJun 1, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05643534

Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Trial registeredFeb 2, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07382167

A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults

Trial startedJan 13, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07382167

A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults

2025

Primary completionDec 17, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT05995899

Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation

Primary completionSep 14, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT06481150

A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

FDA approval (supplemental)Jun 16, 2025· FDA

FDA approved supplemental application for Xphozah 10 Mg (tenapanor) — Labeling (NDA 213931 S-5)

Sponsor: ARDELYX INC. Class: Labeling.

Trial startedJun 1, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06810167

Assessing Tenapanor as a Treatment of CF-related Constipation.

FDA approval (supplemental)May 20, 2025· FDA

FDA approved supplemental application for Ibsrela (tenapanor hydrochloride) — Labeling (NDA 211801 S-14)

Sponsor: ARDELYX INC. Class: Labeling.

FDA approval (supplemental)Mar 21, 2025· FDA

FDA approved supplemental application for Xphozah 10 Mg (tenapanor) — Labeling (NDA 213931 S-2)

Sponsor: ARDELYX INC. Class: Labeling.

Trial registeredFeb 5, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06810167

Assessing Tenapanor as a Treatment of CF-related Constipation.

FDA approval (supplemental)Jan 10, 2025· FDA

FDA approved supplemental application for Ibsrela (tenapanor hydrochloride) — Labeling (NDA 211801 S-12)

Sponsor: ARDELYX INC. Class: Labeling.

Trial startedJan 1, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06460038

Tenapanor in Synucleinopathy-Related Constipation

2024

Trial registeredAug 14, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06553547

4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

Trial startedJul 24, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06553547

4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

Trial registeredJul 1, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06481150

A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Trial startedJul 1, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06481150

A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Trial registeredJun 14, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06460038

Tenapanor in Synucleinopathy-Related Constipation

Primary completionMay 30, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT06203444

An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

Trial startedFeb 6, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT05995899

Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation

Trial registeredJan 12, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06203444

An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

2023

Trial startedNov 27, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT06203444

An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

FDA approvalOct 17, 2023· FDA

FDA approved Xphozah 10 Mg (tenapanor) (NDA 213931)

Sponsor: ARDELYX INC. Class: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated.

Trial registeredAug 16, 2023· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05995899

Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation

Results postedJun 29, 2023· ClinicalTrials.gov

Trial results posted: NCT03427125

A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

Trial registeredJun 15, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05905926

Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Results postedMar 29, 2023· ClinicalTrials.gov

Trial results posted: NCT03988920

A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP

Results postedMar 29, 2023· ClinicalTrials.gov

Trial results posted: NCT04549597

Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia

Results postedMar 6, 2023· ClinicalTrials.gov

Trial results posted: NCT03824587

Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

Trial startedFeb 17, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05905926

Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

2022

Trial registeredDec 8, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05643534

Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Trial startedNov 15, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05643534

Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

FDA approval (supplemental)Apr 5, 2022· FDA

FDA approved supplemental application for Ibsrela (tenapanor hydrochloride) — Labeling (NDA 211801 S-4)

Sponsor: ARDELYX INC. Class: Labeling.

2021

Primary completionOct 13, 2021· ClinicalTrials.gov

Phase 4 primary completion: NCT04549597

Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia

Primary completionJun 26, 2021· ClinicalTrials.gov

Phase 4 primary completion: NCT03988920

A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP

FDA approval (supplemental)May 19, 2021· FDA

FDA approved supplemental application for Ibsrela (tenapanor hydrochloride) — Labeling (NDA 211801 S-3)

Sponsor: ARDELYX INC. Class: Labeling.

FDA approval (supplemental)Mar 5, 2021· FDA

FDA approved supplemental application for Ibsrela (tenapanor hydrochloride) — Labeling (NDA 211801 S-2)

Sponsor: ARDELYX INC. Class: Labeling.

2020

Trial startedNov 20, 2020· ClinicalTrials.gov

Phase 4 trial started: NCT04549597

Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia

Trial registeredSep 16, 2020· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04549597

Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia

Results postedAug 10, 2020· ClinicalTrials.gov

Trial results posted: NCT02675998

An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

Results postedApr 24, 2020· ClinicalTrials.gov

Trial results posted: NCT02727751

A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

Results postedApr 21, 2020· ClinicalTrials.gov

Trial results posted: NCT02621892

A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C

Results postedApr 13, 2020· ClinicalTrials.gov

Trial results posted: NCT02686138

A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C

2019

Primary completionNov 15, 2019· ClinicalTrials.gov

Phase 3 primary completion: NCT03427125

A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

FDA approvalSep 12, 2019· FDA

FDA approved Ibsrela (tenapanor hydrochloride) (NDA 211801)

Sponsor: ARDELYX INC. Class: Type 1 - New Molecular Entity.

Primary completionJul 17, 2019· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT03824587

Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

Trial registeredJun 18, 2019· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT03988920

A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP

Trial startedJun 15, 2019· ClinicalTrials.gov

Phase 4 trial started: NCT03988920

A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP

Trial startedFeb 28, 2019· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT03824587

Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

Trial registeredJan 31, 2019· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT03824587

Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

2018

Trial registeredFeb 9, 2018· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03427125

A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

Trial startedJan 8, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03427125

A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

2017

Primary completionOct 31, 2017· ClinicalTrials.gov

Phase 3 primary completion: NCT02727751

A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

Primary completionAug 31, 2017· ClinicalTrials.gov

Phase 3 primary completion: NCT02686138

A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C

Primary completionMar 31, 2017· ClinicalTrials.gov

Phase 3 primary completion: NCT02621892

A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C

2016

Primary completionDec 31, 2016· ClinicalTrials.gov

Phase 3 primary completion: NCT02675998

An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

Trial registeredApr 5, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02727751

A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

Trial startedMar 31, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02727751

A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C

Trial registeredFeb 19, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02686138

A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C

Trial registeredFeb 5, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02675998

An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

Trial startedJan 31, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02675998

An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

2015

Trial startedDec 31, 2015· ClinicalTrials.gov

Phase 3 trial started: NCT02686138

A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C

Trial registeredDec 4, 2015· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02621892

A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C

Trial startedOct 31, 2015· ClinicalTrials.gov

Phase 3 trial started: NCT02621892

A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.