Drugs / Tenapanor
Tenapanor
also known as
AZD1722 · KHK7791 · RDX5791 · AZD-1722 HYDROCHLORIDE · Ibsrela · TENAPANOR COMPONENT OF RDX-013 · Tenapanor dihydrochloride · TENAPANOR FREE BASE · +2 more
Small molecule targets SLC9A3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | IBSRELA | — | 2019-09-12 | fda.gov ↗ |
Trials 35 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT06203444 | Nov 2023 → May 2024 | lactation disease | Ardelyx | Completed | No outcome recorded |
| Phase 1 | NCT02140268 | May → Aug 2014 | — | Ardelyx | Completed | No outcome recorded |
| Phase 1 | NCT02140281 | May → Aug 2014 | — | Ardelyx | Completed | No outcome recorded |
| Phase 1 | NCT02063386 | Apr → May 2014 | — | Ardelyx | Completed | No outcome recorded |
| Phase 1 | NCT02176252 | Jul → Dec 2013 | — | Ardelyx | Completed | No outcome recorded |
| Phase 1 | NCT02346890 | Apr 2013 | — | Ardelyx | Completed | No outcome recorded |
| Phase 1 | NCT02226783 | Mar → Oct 2013 | — | Ardelyx | Completed | No outcome recorded |
| Phase 1 | NCT02249936 | Feb 2013 | — | Ardelyx | Completed | No outcome recorded |
| Phase 1 | NCT02796131 | Jul → Oct 2011 | — | Ardelyx | Completed | No outcome recorded |
| Phase 1 | NCT02819687 | Nov 2010 → Mar 2011 | — | Ardelyx | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT06460038 | Jan 2025 → Dec 2026 expected | Parkinson disease, synucleinopathy | Cedar Valley Digestive Health Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06553547 | Jul 2024 → Jul 2026 overdue | irritable bowel syndrome | Ardelyx | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03864445 | Apr → Dec 2019 | hyperphosphatemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03864458 | Apr → Dec 2019 | hyperphosphatemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03831607 | Dec 2018 → Nov 2019 | hyperphosphatemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02081534 | Mar → Nov 2014 | hyperphosphatemia | Ardelyx | Completed | No outcome recorded |
| Phase 2 | NCT01764854 | Jan → Oct 2013 | end stage renal failure | Ardelyx | Completed | No outcome recorded |
| Phase 2 | NCT01340053 | May → Dec 2011 | irritable bowel syndrome | Ardelyx | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03824587 | Feb → Jul 2019 | hyperphosphatemia | Ardelyx | Completed | No outcome recorded |
| Phase 2/3 | NCT01923428 | Aug 2013 → Oct 2014 | irritable bowel syndrome | Ardelyx | Completed | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT07382167 | Jan 2026 → Feb 2027 expected | constipation disorder | Ardelyx | Recruiting | No outcome recorded |
| Phase 3 | NCT06810167 | Jun 2025 → Jun 2026 overdue | constipation disorder, cystic fibrosis | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05905926 | Feb 2023 → Jul 2031 expected | irritable bowel syndrome | Ardelyx | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05643534 | Nov 2022 → Sep 2026 expected | irritable bowel syndrome | Ardelyx | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04771780 | Mar 2021 → Jun 2022 | hyperphosphatemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04766385 | Mar → Dec 2021 | hyperphosphatemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03427125 | Jan 2018 → Nov 2019 | hyperphosphatemia | Ardelyx | Completed | No outcome recorded |
| Phase 3 | NCT02727751 | Mar 2016 → Oct 2017 | irritable bowel syndrome | Ardelyx | Completed | No outcome recorded |
| Phase 3 | NCT02675998 | Jan → Dec 2016 | hyperphosphatemia | Ardelyx | Completed | No outcome recorded |
| Phase 3 | NCT02686138 | Dec 2015 → Aug 2017 | irritable bowel syndrome | Ardelyx | Completed | No outcome recorded |
| Phase 3 | NCT02621892 | Oct 2015 → Mar 2017 | irritable bowel syndrome | Ardelyx | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06481150 | Jul 2024 → Sep 2025 | — | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT05995899 | Feb 2024 → Dec 2025 | irritable bowel syndrome | Kyle Staller, MD, MPH | Completed | No outcome recorded |
| Phase 4 | NCT04549597 | Nov 2020 → Oct 2021 | chronic kidney disease, hyperphosphatemia | Ardelyx | Completed | No outcome recorded |
| Phase 4 | NCT03988920 | Jun 2019 → Jun 2021 | end stage renal failure, hyperphosphatemia | Ardelyx | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01847092 Comparator | May 2013 → Mar 2015 | chronic kidney disease, type 2 diabetes mellitus | Ardelyx | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04766398 Comparator | Mar → Sep 2021 | hyperphosphatemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04767581 Comparator | Mar → Aug 2021 | hyperphosphatemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tenapanor | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02675998 ↗ |
| Known as | AZD-1722 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3304485 ↗ |
| Known as | AZD1722 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02140281 ↗ |
| Known as | Ibsrela | ChEMBL registry synonym — accepted as the source's own label CHEMBL3304485 ↗ |
| Known as | KHK7791 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04766398 ↗ |
| Known as | RDX5791 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01340053 ↗ |
| Known as | TENAPANOR COMPONENT OF RDX-013 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3304485 ↗ |
| Known as | Tenapanor dihydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL3304485 ↗ |
| Known as | TENAPANOR FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3304485 ↗ |
| Known as | TENAPANOR HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3304485 ↗ |
| Known as | Xphozah | ChEMBL registry synonym — accepted as the source's own label CHEMBL3304485 ↗ |
| Action | Inhibit | “Tenapanor (RDX5791, AZD1722), a small molecule with minimal systemic availability, is an inhibitor of the sodium/hydrogen exchanger isoform 3 (NHE3).” PMID 27368672 ↗ Jul 2016 |
| Modality | Small molecule | “Tenapanor (RDX5791, AZD1722), a small molecule with minimal systemic availability, is an inhibitor of the sodium/hydrogen exchanger isoform 3 (NHE3).” PMID 27368672 ↗ Jul 2016 |
| Route | Oral | “Starting dose is 15 mg BID PO for 12 Weeks” NCT01847092 ↗ |
| Target | SLC9A3 | “sodium/hydrogen exchanger isoform 3” PMID 38323855 ↗ Feb 2024 |