Numerous clinical trials spanning Phase 1 through Phase 4 evaluate tenapanor for indications including irritable bowel syndrome with constipation (IBS-C), chronic idiopathic constipation, and hyperphosphatemia in chronic kidney disease. Sponsored by pharmaceutical entities such as Ardelyx alongside academic centers including Massachusetts General Hospital and the University of Texas Southwestern Medical Center, these studies range from Phase 1 pharmacokinetic evaluations to Phase 3 trials. Current recruitment statuses across this clinical pipeline vary from active and recruiting to completed.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05905926 | ENROLLING_BY_INVITATION | Irritable Bowel Syndrome With Constipation (IBS-C) |
Ardelyx |
2023-02-17 | PHASE3 |
| NCT07382167 | RECRUITING | Chronic Idiopathic Constipation (CIC) |
Ardelyx |
2026-01-13 | PHASE3 |
| NCT06460038 | RECRUITING | Synucleinopathy; Parkinson's Disease |
Cedar Valley Digestive Health Center |
2025-01-01 | PHASE2 |
| NCT05643534 | ACTIVE_NOT_RECRUITING | Irritable Bowel Syndrome With Constipation (IBS-C) |
Ardelyx |
2022-11-15 | PHASE3 |
| NCT06553547 | COMPLETED | Irritable Bowel Syndrome With Constipation (IBS-C) |
Ardelyx |
2024-07-24 | PHASE2 |
| NCT06810167 | ACTIVE_NOT_RECRUITING | Cystic Fibrosis; Constipation |
Massachusetts General Hospital |
2025-06-01 | PHASE3 |
| NCT05995899 | COMPLETED | IBS; IBS - Irritable Bowel Syndrome |
Kyle Staller, MD, MPH |
2024-02-06 | PHASE4 |
| NCT06481150 | COMPLETED | Hyperoxaluria |
University of Texas Southwestern Medical Center |
2024-07-01 | PHASE4 |
| NCT06203444 | COMPLETED | Lactation |
Ardelyx |
2023-11-27 | PHASE1 |
| NCT04549597 | COMPLETED | Chronic Kidney Disease Requiring Chronic Dialysis; Hyperphosphatemia |
Ardelyx |
2020-11-20 | PHASE4 |
| NCT03988920 | COMPLETED | Hyperphosphatemia; End Stage Renal Disease |
Ardelyx |
2019-06-15 | PHASE4 |
| NCT03427125 | COMPLETED | Hyperphosphatemia |
Ardelyx |
2018-01-08 | PHASE3 |
| NCT03824587 | COMPLETED | Hyperphosphatemia |
Ardelyx |
2019-02-28 | PHASE2; PHASE3 |
| NCT02727751 | COMPLETED | Constipation Predominant Irritable Bowel Syndrome |
Ardelyx |
2016-03 | PHASE3 |
| NCT02686138 | COMPLETED | Constipation Predominant Irritable Bowel Syndrome |
Ardelyx |
2015-12 | PHASE3 |
| NCT02621892 | COMPLETED | Constipation Predominant Irritable Bowel Syndrome |
Ardelyx |
2015-10 | PHASE3 |
| NCT02675998 | COMPLETED | Hyperphosphatemia |
Ardelyx |
2016-01 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-06-04)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).