27 completed, 2 recruiting, 1 active not recruiting, 1 enrolling by invitation. 11 Phase 3, 10 Phase 1, 10 Phase 2, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 11 | Completed 8, Active not recruiting 1, Enrolling by invitation 1, Recruiting 1 |
| Phase 1 | 10 | Completed 10 |
| Phase 2 | 10 | Completed 8, Recruiting 1, Terminated 1 |
| Phase 4 | 3 | Completed 3 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults Tenapanor 5 mg BID, Tenapanor 25 mg BID, Tenapanor 50 mg BID - Chronic Idiopathic Constipation (CIC) | Phase 3 | Recruiting | Ardelyx | 692 | 2026-01-13 | 2026-06-04 |
| Assessing Tenapanor as a Treatment of CF-related Constipation. Tenapanor - Cystic Fibrosis, Constipation | Phase 3 | Active not recruiting | Massachusetts General Hospital | 25 | 2025-06-01 | 2026-08-21 |
| Tenapanor in Synucleinopathy-Related Constipation Tenapanor, Placebo - Synucleinopathy, Parkinson's Disease | Phase 2 | Recruiting | Cedar Valley Digestive Health Center | 30 | 2025-01-01 | 2025-02-10 |
| 4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs Tenapanor, Placebo - Irritable Bowel Syndrome With Constipation (IBS-C) | Phase 2 | Completed | Ardelyx | 72 | 2024-07-24 | 2026-08-19 |
| Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation Tenapanor - IBS, IBS - Irritable Bowel Syndrome | Phase 4 | Completed | Kyle Staller, MD, MPH | 36 | 2024-02-06 | 2026-03-12 |
| An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females Tenapanor - Lactation | Phase 1 | Completed | Ardelyx | 7 | 2023-11-27 | 2024-07-11 |
| Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C Tenapanor - Irritable Bowel Syndrome With Constipation (IBS-C) | Phase 3 | Enrolling by invitation | Ardelyx | 150 | 2023-02-17 | 2026-06-04 |
| Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years Tenapanor 50 MG, Tenapanor 25 mg bid, Placebo - Irritable Bowel Syndrome With Constipation (IBS-C) | Phase 3 | Completed | Ardelyx | 180 | 2022-11-15 | 2026-09-22 |
| A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia RDX013, Placebo - Hyperkalemia | Phase 2 | Completed | Ardelyx | 109 | 2021-01-11 | 2022-05-04 |
| Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia Tenapanor - Chronic Kidney Disease Requiring Chronic Dialysis, Hyperphosphatemia | Phase 4 | Completed | Ardelyx | 333 | 2020-11-20 | 2023-03-29 |
| A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP Tenapanor, Sevelamer Carbonate - Hyperphosphatemia, End Stage Renal Disease | Phase 4 | Completed | Ardelyx | 172 | 2019-06-15 | 2023-03-29 |
| Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy Tenapanor, Placebo, Phosphate Binder Agents - Hyperphosphatemia | Phase 2 / Phase 3 | Completed | Ardelyx | 236 | 2019-02-28 | 2023-03-06 |
| A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis Tenapanor, Placebo, Sevelamer Carbonate - Hyperphosphatemia | Phase 3 | Completed | Ardelyx | 1559 | 2018-01-08 | 2023-06-29 |
| A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia RDX227675, Placebo - Hyperkalemia | Phase 2 | Terminated | Ardelyx | 60 | 2017-01-01 | 2019-12-26 |
| A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C Tenapanor - Constipation Predominant Irritable Bowel Syndrome | Phase 3 | Completed | Ardelyx | 312 | 2016-03-01 | 2020-09-09 |
| An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD) Tenapanor, Placebo - Hyperphosphatemia | Phase 3 | Completed | Ardelyx | 219 | 2016-01-01 | 2020-08-10 |
| A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C Tenapanor, Placebo - Constipation Predominant Irritable Bowel Syndrome | Phase 3 | Completed | Ardelyx | 593 | 2015-12-01 | 2020-04-22 |
| 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 Tenapanor, Placebo - Constipation Predominant Irritable Bowel Syndrome | Phase 3 | Completed | Ardelyx | 606 | 2015-10-01 | 2020-04-21 |
| To Evaluate the Effect of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers Midazolam, AZD1722, AZD1722 and Midazolam - Healthy Volunteers | Phase 1 | Completed | Ardelyx | 65 | 2014-05-01 | 2015-09-22 |
| To Assess the Effect of AZD1722 on the Pharmacokinetics of Cefadroxil in Healthy Volunteers Treatment A (cefadroxil alone), Treatment B - AZD1722 followed by cefadroxil - Healthy Volunteers | Phase 1 | Completed | Ardelyx | 71 | 2014-05-01 | 2015-09-22 |
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Hyperphosphatemia (6) · Kidney Failure, Chronic (3) · Constipation (2) · Hyperkalemia (2) · Renal Insufficiency, Chronic (2) · Albuminuria (1) · Breast Feeding (1) · Cystic Fibrosis (1) · Diabetes Mellitus, Type 2 (1) · Irritable Bowel Syndrome (1) · Parkinson Disease (1) · Synucleinopathies (1)
tenapanor (28) · Sevelamer (4) · BID protein, human (2) · Omeprazole (2) · Calcium Carbonate (1) · Cefadroxil (1) · Midazolam (1) · calcium acetate (1) · ferric citrate (1) · sucroferric oxyhydroxide (1)
United States (29) · United Kingdom (2) · Poland (1) · Slovakia (1)
David P Rosenbaum, Ph.D. (10) · David P Rosenbaum, PhD (4) · Jocelyn Tabora (3) · David P. Rosenbaum, Ph.D (2) · Brian Quach (1) · Christoher D Velez, MD (1) · David Mathews, MD (1) · Eleanor Lisbon, MD (1) · Geoffrey A Block, MD (1) · Harichandana Punukula, PharmD, MS (1) · Ravindra Mallavarapu, MD (1) · Richard A. Manfready, MD, AM, FACP (1) · Susan Edelstein, PhD (1)
PMID 38323855, PMID 37853560, PMID 33337659, PMID 37668173, PMID 41601848, PMID 29363027, PMID 27368672, PMID 29617976, PMID 31934897, PMID 33766811, PMID 35372979, PMID 40576086