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Clinical trials
catalyst calendar across sponsors →Studies where ARDX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
29 interventional · 13 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-CNCT05905926Safety Measure Assessment (Adverse Event)Open-label · Health services research | Phase 3 | Enrolling by invitation | Drug: Tenapanor | Irritable Bowel Syndrome With Constipation (IBS-C) | 150 | Jul 2031 | ≤ 1,807 d | 2026-06-04 |
| A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in AdultsNCT07382167Durable complete spontaneous bowel movements (CSBM) responseRandomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Tenapanor 5 mg BID, Tenapanor 25 mg BID, Tenapanor 50 mg BID, Placebo | Chronic Idiopathic Constipation (CIC) | 692 | 2027-02-26 | in 191 d | 2026-06-04 |
| Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 YearsNCT056435346/12-week APS (abdominal pain and SBM) +2 responseRandomized · Double-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Tenapanor 50 MG, Tenapanor 25 mg bid, Placebo | Irritable Bowel Syndrome With Constipation (IBS-C) | 180 | 2026-09-01 | in 13 d | 2026-06-04 |
| 4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 YrsNCT06553547Average weekly SBM (week 4)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Tenapanor, Placebo | Irritable Bowel Syndrome With Constipation (IBS-C) | 72 | 2026-07-07actual | — | 2026-08-19 |
| An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating FemalesNCT06203444Concentration of tenapanor and its major metabolite in breast milkOpen-label · Treatment | Phase 1 | Completed | Drug: Tenapanor | Lactation | 7 | 2024-05-30actual | — | 2024-07-11 |
| A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of HyperkalemiaNCT04780841Change in serum potassium; Part ARandomized · Single-masked · Treatment | Phase 2 | Completed | Drug: RDX013, Placebo | Hyperkalemia | 109 | 2021-12-28actual | — | 2022-05-04 |
| Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of HyperphosphatemiaNCT04549597results2023-03-29Effect of Tenapanor to Achieve Target s-P Levels of Less Than or Equal to 5.5 mg/dLRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Tenapanor | Chronic Kidney Disease Requiring Chronic Dialysis, Hyperphosphatemia | 333 | 2021-10-13actual | — | 2023-03-29 |
| A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HPNCT03988920results2023-03-29Achieving Normal Serum Phosphorus LevelNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Tenapanor, Sevelamer Carbonate | Hyperphosphatemia, End Stage Renal Disease | 172 | 2021-06-26actual | — | 2023-03-29 |
| A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on DialysisNCT03427125results2023-06-29Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the Responder PopulationRandomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tenapanor, Placebo, Sevelamer Carbonate | Hyperphosphatemia | 1,559 | 2019-11-15actual | — | 2023-06-29 |
| Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder TherapyNCT03824587results2023-03-06Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.Randomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: Tenapanor, Placebo, Phosphate Binder Agents | Hyperphosphatemia | 236 | 2019-07-17actual | — | 2023-03-06 |
| A Long-Term Safety Study of Tenapanor for the Treatment of IBS-CNCT02727751results2020-04-24Adverse Events in >2% PatientsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tenapanor | Constipation Predominant Irritable Bowel Syndrome | 312 | Oct 2017actual | — | 2020-09-09 |
| A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-CNCT02686138results2020-04-13Percentage of Subjects With Overall Response for 6 Out of 12 WeeksRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tenapanor, Placebo | Constipation Predominant Irritable Bowel Syndrome | 593 | Aug 2017actual | — | 2020-04-22 |
| A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of HyperkalemiaNCT03018067Exponential Rate of Change in Serum Potassium from BaselineRandomized · Single-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Sponsor stopped program\] | Drug: RDX227675, Placebo | Hyperkalemia | 60 | May 2017actual | — | 2019-12-26 |
| A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-CNCT02621892results2020-04-216 of 12 Week Overall Responder RateRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tenapanor, Placebo | Constipation Predominant Irritable Bowel Syndrome | 606 | Mar 2017actual | — | 2020-04-21 |
| An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)NCT02675998results2020-08-10Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor ArmsRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Tenapanor, Placebo | Hyperphosphatemia | 219 | Dec 2016actual | — | 2020-08-10 |
| A Study in CKD Patients With Type 2 Diabetes Mellitus and AlbuminuriaNCT01847092results2020-05-27Changes in Urine Albumin to Creatinine Ratio (UACR)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: AZD1722, Placebo | Chronic Kidney Disease, Type 2 Diabetes Mellitus | 154 | Mar 2015actual | — | 2020-05-27 |
| Dose Finding Study to Treat High Phosphate Levels in the Blood.NCT02081534results2020-09-14Change in Serum Phosphate LevelsRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: AZD1722, Placebo | Hyperphosphatemia | 162 | Nov 2014actual | — | 2020-09-14 |
| The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C)NCT01923428results2020-01-10Percent Complete Spontaneous Bowel Movement Responders vs PlaceboRandomized · Quadruple-masked · Treatment | Phase 2/3 | Completed | Drug: AZD1722, Placebo | Constipation Predominant Irritable Bowel Syndrome | 356 | Oct 2014actual | — | 2020-04-08 |
| To Evaluate the Effect of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy VolunteersNCT02140268To evaluate the pharmacokinetics of midazolam when administered after AZD1722 by assessment of area under the concentration-time curve (AUC) and maximal plasma concentration (Cmax) of midazolamNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Midazolam, AZD1722, AZD1722 and Midazolam | Healthy Volunteers | 65 | Aug 2014actual | — | 2015-09-22 |
| To Assess the Effect of AZD1722 on the Pharmacokinetics of Cefadroxil in Healthy VolunteersNCT02140281To evaluate the pharmacokinetics of cefadroxil when administered after AZD1722 by assessment of area under the concentration-time curve (AUC) and maximal plasma concentration (Cmax) of cefadroxilRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: Treatment A (cefadroxil alone), Treatment B - AZD1722 followed by cefadroxil | Healthy Volunteers | 71 | Aug 2014actual | — | 2015-09-22 |
| AZD1722 Open Label, Absorption Distribution Metabolism and Excretion StudyNCT02063386Percentage of radioactive dose recovered in urine and fecesNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: AZD1722 | Healthy Volunteers | 26 | May 2014actual | — | 2015-09-22 |
| Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese SubjectsNCT02176252Number of patients with adverse eventsQuadruple-masked · Treatment | Phase 1 | Completed | Drug: AZD1722, Placebo | Healthy Volunteer | 83 | Dec 2013actual | — | 2014-06-27 |
| Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on HemodialysisNCT01764854results2020-08-10Change in Mean Weekly Interdialytic Weight Gain (IDWG)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: AZD1722 (in-patient), Placebo (in-patient), AZD1722 (out-patient), Placebo | End Stage Renal Disease, Chronic Kidney Disease Stage 5, ESRD | 88 | Oct 2013actual | — | 2020-08-10 |
| D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy SubjectsNCT02226783Pharmacodynamic:- To evaluate the effect of intake of food in comparison to fasting condition on PD of AZD1722 following a twice-daily administration of AZD1722 tablet formulationRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: AZD1722 salt tablet, AZD1722 free base tablet, AZD1722 free base tablet + Omeprazole | Healthy Volunteers Food Interaction Study | 37 | Oct 2013actual | — | 2015-09-22 |
| A Phase 1 Study to Examine the Effect of Renvela on the Pharmacodynamics of AZD1722NCT02346890Sodium levels in stool and urineRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: AZD1722, Renvela | Healthy | 16 | Apr 2013actual | — | 2015-01-27 |
| A Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 FormulationsNCT02249936Number of patients with adverse eventsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: AZD1722, Omeprazole | Healthy | 18 | Feb 2013actual | — | 2014-09-26 |
| A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)NCT01340053results2019-10-15Complete Spontaneous Bowel Movement (CSBM) Frequency Change From BaselineRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: RDX5791 | Constipation Predominant Irritable Bowel Syndrome | 186 | Dec 2011actual | — | 2019-10-15 |
| Safety, Tolerability, and Pharmacodynamics of RDX5791 in Healthy VolunteersNCT02796131Safety of different dosing regimens of RDX5791Randomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: RDX5791, Placebo | Healthy | 105 | Oct 2011actual | — | 2016-06-10 |
| Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RDX5791 in Healthy VolunteersNCT02819687Adverse eventsNon-randomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: RDX5791, Placebo | Healthy | 80 | Mar 2011actual | — | 2016-06-30 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19