tenapanor
Trade name: Ibsrela
Approved
Sep 12, 2019
Tenapanor is an inhibitor of the sodium-proton (Na(+)/H(+)) exchanger NHE3 and reduces sodium absorption in the GI tract, thus increasing intestinal fluid. Ardelyx has completed Phase 3 development of tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C) and submitted a new drug application to the U.S. Food and Drug Administration for the treatment of patients with IBS-C. In addition, tenapanor successfully completed phase III clinical trial for the treatment of hyperphosphatemia in people with end-stage renal disease who are on dialysis and RDX013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. — NCATS
Clinical trial activity
37 trials · 9 clinical orgs · 1 marketing orgs
Earliest trial started Nov 1, 2010 (NCT02819687)
Timeline
Indications
Studied for
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Constipation · Phase 3
- Cystic Fibrosis · Phase 3
- Diabetes Mellitus, Type 2 · Phase 2
- Healthy Volunteers · Phase 1
- Hyperoxaluria · Phase 4
- Hyperphosphatemia · Phase 4
- Irritable Bowel Syndrome · Phase 4
- Kidney Failure, Chronic · Phase 4
- Lactation · Phase 1
- Parkinson Disease · Phase 2
- Renal Insufficiency, Chronic · Phase 2
- Synucleinopathies · Phase 2
Mechanism of action
- Sodium/hydrogen exchanger 3INHIBITOR
SLC9A3 inhibitor
Acts locally in the gut, where it reduces absorption of sodium and phosphate.
Approval history
- approvedSep 12, 2019
Chemistry & pharmacology
SMILES
CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1- Mol. weight
- 1145.07 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3304485 ↗
- WikipediaTenapanor ↗
- NCATSWYD79216A6 ↗
- ChEMBLCHEMBL3301627 ↗
Also known as
- azd1722
- azd1722
- azd1722
- azd-1722
- azd-1722
- azd-1722 hydrochloride
- azd-1722 hydrochloride
- rdx5791
- rdx5791
- rdx5791
- rdx-5791
- rdx-5791
- tenapanor
- tenapanor
- tenapanor
- tenapanor
- tenapanor
- tenapanor hydrochloride
- tenapanor hydrochloride
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06810167 | Phase 3 | Feb 1, 2025 | Ardelyx, Harvard University |
| NCT06460038 | Phase 2 | Dec 31, 2024 | Ardelyx, Cedar Valley Digestive Health Center |
| NCT06553547 | Phase 2 | Jul 24, 2024 | Ardelyx |
| NCT06481150 | Phase 4 | Jul 1, 2024 | National Center for Advancing Translational Science (NCATS), The University of Texas, Dallas |
| NCT05995899 | Phase 4 | Dec 31, 2023 | Ardelyx, Harvard University |
| NCT06203444 | Phase 1 | Nov 27, 2023 | Ardelyx |
| NCT05905926 | Phase 3 | Feb 17, 2023 | Ardelyx |
| NCT05643534 | Phase 3 | Nov 15, 2022 | Ardelyx |
| NCT04766398 | Phase 3 | Mar 15, 2021 | Kyowa Hakko Kirin |
| NCT04771780 | Phase 3 | Mar 15, 2021 | Kyowa Hakko Kirin |
| NCT04767581 | Phase 3 | Mar 8, 2021 | Kyowa Hakko Kirin |
| NCT04766385 | Phase 3 | Mar 3, 2021 | Kyowa Hakko Kirin |
| NCT04549597 | Phase 4 | Nov 6, 2020 | Ardelyx |
| NCT03988920 | Phase 4 | Jun 30, 2019 | Ardelyx |
| NCT03864445 | Phase 2 | Apr 29, 2019 | Kyowa Hakko Kirin |
| NCT03864458 | Phase 2 | Apr 15, 2019 | Kyowa Hakko Kirin |
| NCT03824587 | Phase 2/Phase 3 (Phase 3) | Feb 28, 2019 | Ardelyx |
| NCT03831607 | Phase 2 | Dec 27, 2018 | Kyowa Hakko Kirin |
| NCT03427125 | Phase 3 | Jan 8, 2018 | Ardelyx |
| NCT02727751 | Phase 3 | Mar 1, 2016 | Ardelyx |
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Ardelyx | For profit | 29 | 26 | 4 | 2010 |
| Kyowa Hakko Kirin | For profit | 7 | 7 | 2 | 2018 |
| AstraZeneca | For profit | 5 | 0 | 2 | 2013 |
| IQVIA | For profit | 3 | 0 | 1 | 2013 |
| Harvard University | Academic/Hospital | 2 | 2 | 2 | 2023 |
| Cedar Valley Digestive Health Center | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Denver Nephrology | Academic/Hospital | 1 | 0 | 1 | 2014 |
| National Center for Advancing Translational Science (NCATS) | Government | 1 | 0 | 1 | 2024 |
| The University of Texas, Dallas | Academic/Hospital | 1 | 1 | 1 | 2024 |