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 · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hyperphosphatemia 4 milestones | |||||
| Filed | Japan (PMDA) | — | hyperphosphatemia | 2022-10-31 | “has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) for tenapanor” ardelyx.com ↗ |
| Filed | US (FDA) | — | hyperphosphatemia | 2020-06-30 | “Submitted a New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis” ardelyx.com ↗ “submission of a New Drug Application (NDA) for tenapanor to the U.S. Food and Drug Administration (FDA)” ardelyx.com ↗ |
| Rejected (CRL) | US (FDA) | XPHOZAH | hyperphosphatemia | — | “provided an update regarding the appeal to the Complete Response Letter for the New Drug Application for XPHOZAH (tenapanor).” ardelyx.com ↗ |
| Filed | China (NMPA) | — | hyperphosphatemia | — | “A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma.” ardelyx.com ↗ “A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma.” ardelyx.com ↗ |
| Filed irritable bowel syndrome 1 milestone | |||||
| Filed | US (FDA) | — | irritable bowel syndrome | 2018-09-13 | “Ardelyx recently submitted a New Drug Application for marketing authorization of tenapanor for the treatment of people with IBS-C” ardelyx.com ↗ “New Drug Application for U.S. Marketing Authorization of Tenapanor for IBS-C Submitted to U.S. Food and Drug Administration” ardelyx.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | IBSRELA | — | 2019-09-12 | fda.gov ↗ |
Trials 35
| 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 | NCT02140281 | May → Aug 2014 | — | Ardelyx | Completed | No outcome recorded |
| Phase 1 | NCT02140268 | 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 · 1 met primary · 1 missed | ||||||
| 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 | Met primary |
| Phase 2 | NCT01764854 | Jan → Oct 2013 | end stage renal failure | Ardelyx | Completed | Missed primary |
| Phase 2 | NCT01340053 | May → Dec 2011 | irritable bowel syndrome | Ardelyx | Completed | No outcome recorded |
| Phase 2/32 trials · 2 met primary | ||||||
| Phase 2/3 | NCT03824587 | Feb → Jul 2019 | hyperphosphatemia | Ardelyx | Completed | Met primary |
| Phase 2/3 | NCT01923428 | Aug 2013 → Oct 2014 | irritable bowel syndrome | Ardelyx | Completed | Met primary |
| Phase 311 trials · 4 met primary | ||||||
| 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 → Aug 2026 | irritable bowel syndrome | Ardelyx | Completed | 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 | Met primary |
| Phase 3 | NCT02727751 | Mar 2016 → Oct 2017 | irritable bowel syndrome | Ardelyx | Completed | No outcome recorded |
| Phase 3 | NCT02675998 | Jan → Dec 2016 | hyperphosphatemia | Ardelyx | Completed | Met primary |
| Phase 3 | NCT02686138 | Dec 2015 → Aug 2017 | irritable bowel syndrome | Ardelyx | Completed | Met primary |
| Phase 3 | NCT02621892 | Oct 2015 → Mar 2017 | irritable bowel syndrome | Ardelyx | Completed | Met primary |
| Phase 44 trials · 1 missed | ||||||
| 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 | Missed primary |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT01847092 Comparator | May 2013 → Mar 2015 | chronic kidney disease, type 2 diabetes mellitus | Ardelyx | Completed | No outcome recorded |
| 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 |
News releases announcing trial results or a regulatory action · 67
| Date | Issuer | Release |
|---|---|---|
| 2026-04-27 | Ardelyx | Results Ardelyx Announces Abstract Accepted for Poster Presentation at the NKF’s Spring Clinical Meetings ardelyx.com ↗
Tenapanor Decreases Serum Phosphate Without Altering Other Serum Electrolytes in Patients with Chronic Kidney Disease with Hyperphosphatemia on Dialysis |
| 2026-03-09 | Ardelyx | Results Ardelyx Announces Publication of a Review Article Demonstrating Rapid and Meaningful Symptom Relief with Tenapanor in IBS-C ardelyx.com ↗
Patients taking tenapanor reported improvements in bowel movement frequency as early as two weeks, and meaningful relief from abdominal symptoms including pain, discomfort, and bloating within 4–5 weeks. |
| 2025-11-07 | Ardelyx | Results Real-World Evidence Studies of XPHOZAH® (tenapanor) Demonstrate Patient Satisfaction and Reduction in Serum Phosphate with XPHOZAH in Data Presented at ASN Kidney Week ardelyx.com ↗
Our results show the impact XPHOZAH can have in reducing serum phosphorus levels for these patients, and that its’ effectiveness extends outside the clinical trial setting and into the real-world. |
| 2025-10-28 | Ardelyx | Results Ardelyx Presents Data that Continues to Support the Benefits of IBSRELA® (tenapanor) at the American College of Gastroenterology’s 2025 Annual Meeting ardelyx.com ↗
Post-hoc analysis of T3MPO-1 and T3MPO-2 studies demonstrates effectiveness of IBSRELA in reducing abdominal bloating for patients with IBS-C |
| 2025-04-24 | Ardelyx | Results Ardelyx Announces Three Abstracts Accepted for Poster Presentations at Digestive Disease Week 2025 Conference ardelyx.com ↗
Neither Tenapanor nor its Major Metabolite Were Detected in the Breast Milk of Healthy Lactating Females After 4 Days of Dosing: A Phase 1, Open-Label, Pharmacokinetic Study |
| 2025-02-26 | Ardelyx | Regulatory Tenapanor Approved in China for Hyperphosphatemia ardelyx.com ↗ |
| 2024-10-24 | Ardelyx | Results Ardelyx Shares Additional Data Supporting First-In-Class XPHOZAH® (tenapanor) at the American Society of Nephrology’s Kidney Week ardelyx.com ↗
today announced that data supporting additional positive clinical observations of XPHOZAH ® (tenapanor) was presented in a series of poster presentations at the American Society of Nephrology’s (ASN) Kidney Week, currently taking place in San Diego . |
| 2024-05-21 | Ardelyx | Results Ardelyx Presents Additional Data at the 2024 Digestive Disease Week Conference on IBSRELA® (tenapanor), a First-In-Class Treatment for IBS-C in Adults ardelyx.com ↗
today announced that data supporting additional positive clinical observations of IBSRELA ® (tenapanor) was presented at the 2024 Digestive Disease Week Conference (DDW), currently taking place in Washington, D.C. |
| 2024-05-16 | Ardelyx | Results Ardelyx Presents Additional Data at the NKF 2024 Spring Clinical Meetings on XPHOZAH® (tenapanor) ardelyx.com ↗ |
| 2023-11-15 | Ardelyx | Regulatory XPHOZAH® (tenapanor) Granted Orphan Drug Designation by U.S. FDA for the Treatment of Pediatric Hyperphosphatemia ardelyx.com ↗
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH ® (tenapanor) for the treatment of pediatric hyperphosphatemia. |
| 2023-11-03 | Ardelyx | Results Ardelyx Shares Positive Data from Studies of XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor, at ASN Kidney Week 2023 ardelyx.com ↗
The study showed that a lower proportion of patients treated with tenapanor versus sevelamer experienced a serious adverse event (SAE) |
| 2023-10-23 | Ardelyx | Results Ardelyx Shares Positive Data on Symptom Response During Treatment With IBSRELA® (tenapanor) for IBS-C and hosts IBS-C Product Theater at ACG 2023 ardelyx.com ↗
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, announced that they will share positive data on IBSRELA ® (tenapanor) via an oral presentation and two posters at the American College of Gastroenterology (ACG) annual meeting, being held October 20 to 25 in Vancouver, Canada . |
| 2023-10-17 | Ardelyx | Regulatory FDA Approves XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor ardelyx.com ↗ |
| 2023-10-04 | Ardelyx | Results Ardelyx Shares Preliminary Data on Use of IBSRELA® (tenapanor) in Pediatric IBS-C Patients at NASPGHAN 2023 ardelyx.com ↗
The data presented at NASPGHAN, while preliminary and blinded to treatment assignment, is an important step towards assessing the safety and efficacy of IBSRELA among pediatric populations. |
| 2023-09-28 | Ardelyx | Results Ardelyx Announces Publication of Positive Results from T3MPO-3 Long-Term Open-Label Safety Trial of Tenapanor for IBS-C in the Journal of Neurogastroenterology and Motility ardelyx.com ↗
today announced the publication of results from the T3MPO-3 long-term open-label safety trial of IBSRELA ® (tenapanor) for irritable bowel syndrome with constipation (IBS-C) in the Journal of Neurogastroenterology and Motility (JNM). |
| 2023-09-25 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces Approval of PHOZEVEL® for Improvement of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis in Japan kyowakirin.com ↗
Kyowa Kirin Co., Ltd. (President and CEO: Masashi Miyamoto, TSE: 4151, “Kyowa Kirin”) announced today that it has received an approval for manufacturing and marketing PHOZEVEL® (Generic name: tenapanor hydrochloride, Development code: KHK7791)*1 , a small molecule compound licensed from Ardelyx, Inc. (Waltham, Mass., USA; Nasdaq: ARDX, President and CEO: Mike Raab, "Ardelyx")*2, for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis as of today. |
| 2023-09-25 | Ardelyx | Regulatory Tenapanor for Hyperphosphatemia Approved in Japan ardelyx.com ↗
The approval of tenapanor for hyperphosphatemia in Japan is a historic moment for Ardelyx and CKD patients on dialysis. |
| 2023-09-11 | Ardelyx | Results Ardelyx Showcased Encouraging Data on Treatment Satisfaction and Efficacy of IBSRELA® (tenapanor) for IBS-C at GHAPP 2023 ardelyx.com ↗
The data presented at GHAPP demonstrate that people with IBS-C are experiencing significant improvements in abdominal symptom scores when treated with IBSRELA and that efficacy and durability are consistent across a diverse group of patients. |
| 2023-07-13 | Ardelyx | Regulatory Ardelyx Announces Acceptance of New Drug Application for Tenapanor for Hyperphosphatemia in China ardelyx.com ↗
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that a New Drug Application (NDA) for tenapanor has been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the control of serum phosphorus in adult patients with chronic kidney disease on hemodialysis. |
| 2023-05-17 | Ardelyx | Regulatory Ardelyx Announces FDA Acceptance and Six-Month Review for Resubmission of its New Drug Application of XPHOZAH® (tenapanor) ardelyx.com ↗
The FDA has determined that the NDA is a class 2 review, which results in a six-month review period from the date of resubmission. |
| 2023-05-09 | Ardelyx | Results Ardelyx Presents Positive Data at DDW 2023 on IBSRELA® (tenapanor), a First-In-Class Treatment for IBS-C in Adults ardelyx.com ↗
The data presented in this poster demonstrate that patients treated with IBSRELA experienced significant improvement in abdominal symptoms and that this improvement correlates with patient reports of adequate relief. |
| 2023-04-18 | Ardelyx | Regulatory Ardelyx Resubmits New Drug Application to U.S. Food and Drug Administration for XPHOZAH® (tenapanor) ardelyx.com ↗
today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of XPHOZAH (tenapanor) |
| 2023-04-12 | Ardelyx | Results Ardelyx Presents Positive Data Further Supporting Efficacy and Safety of XPHOZAH® (tenapanor) at National Kidney Foundation 2023 Spring Clinical Meetings ardelyx.com ↗
XPHOZAH consistently lowered serum phosphate in patients, independent of race |
| 2022-12-29 | Ardelyx | Regulatory FDA Grants Appeal for Ardelyx's XPHOZAH® (tenapanor) ardelyx.com ↗
In the response letter, OND directed the FDA's Division of Cardiology and Nephrology (DCN) to work with Ardelyx to develop an appropriate label. |
| 2022-11-16 | Ardelyx | Regulatory Ardelyx Announces FDA Advisory Committee Votes that the Benefits of XPHOZAH® (tenapanor) Outweigh its Risks for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis ardelyx.com ↗
The Advisory Committee voted 9:4 in favor of XPHOZAH as a monotherapy and 10:2 in favor of XPHOZAH in combination with phosphate binders |
| 2022-11-03 | Ardelyx | Results Ardelyx Presents New Data Analyses at Kidney Week 2022, Further Supporting the Clinical Relevance of XPHOZAH® (tenapanor), an Investigational, Phosphate Absorption Inhibitor to Control Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dial ardelyx.com ↗
Notably, early response to XPHOZAH was found to be predictive of continued response throughout the treatment period. |
| 2022-10-31 | Ardelyx | Regulatory Ardelyx Collaboration Partner, Kyowa Kirin, Announces Submission of New Drug Application for Tenapanor for Hyperphosphatemia in Japan ardelyx.com ↗ |
| 2022-10-24 | Ardelyx | Results Ardelyx to Present Poster Presentations on IBSRELA® (tenapanor) for Adult Patients with IBS-C at the American College of Gastroenterology 2022 Annual Scientific Meeting ardelyx.com ↗
In adult patients with IBS-C, IBSRELA was found to improve abdominal symptom scores, which included symptoms such as abdominal pain, discomfort, bloating, fullness and cramping, over the 26-week treatment period. |
| 2022-06-21 | Ardelyx | Regulatory Ardelyx Announces FDA Advisory Committee Meeting to Review XPHOZAH® NDA Tentatively Scheduled for November 16, 2022 ardelyx.com ↗
The Advisory Committee will discuss the company's New Drug Application (NDA) for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. |
| 2022-05-24 | Ardelyx | Results Ardelyx Presents Data at DDW 2022 on IBSRELA® (tenapanor), a First-In-Class Treatment for IBS-C in Adults ardelyx.com ↗
In this 26-week study, treatment with IBSRELA ameliorated a variety of abdominal symptoms associated with IBS-C, with improvements in abdominal pain, bloating, discomfort, cramping, and fullness observed as early as week 1 and sustained for the entire 26 weeks. |
| 2022-04-25 | Ardelyx | Regulatory Ardelyx Announces FDA Plan to Convene Advisory Committee for XPHOZAH® (tenapanor) ardelyx.com ↗
Accordingly, the OND intends to direct the Division of Cardiology and Nephrology to bring the XPHOZAH New Drug Application (NDA) to the Cardiovascular and Renal Drugs Advisory Committee |
| 2022-04-07 | Ardelyx | Results Ardelyx Presents Positive Data Further Supporting Efficacy and Safety of XPHOZAH® (tenapanor) at National Kidney Foundation 2022 Spring Clinical Meetings ardelyx.com ↗
Patients reported improved experience with phosphate management routine during OPTIMIZE study, compared to previous phosphate lowering therapies |
| 2021-12-13 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Positive Phase 3 Results of Tenapanor (KHK7791) for Hyperphosphatemia in Patients on Hemodialysis in Japan kyowakirin.com ↗
Statistically significant decrease in serum phosphorous levels was observed in the KHK7791 group relative to the placebo group. |
| 2021-11-05 | Ardelyx | Results Ardelyx Reports Additional Positive Data Supporting Clinical Utility of Tenapanor at ASN's Kidney Week 2021 ardelyx.com ↗
First patient reported outcome data on tenapanor from OPTIMIZE trial demonstrates improved overall patient experience and benefit of one pill twice daily dosing regimen with tenapanor compared to binder therapies |
| 2021-09-03 | Ardelyx | Results Ardelyx Announces Publication of 52-Week Phase 3 PHREEDOM Trial ardelyx.com ↗
Publication highlights clinically meaningful reduction in mean serum phosphorus from 7.7 mg/dL to 5.1 mg/dL at end of 26-week treatment period in the efficacy analysis set. |
| 2021-07-29 | Ardelyx | Regulatory Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis ardelyx.com ↗
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. |
| 2021-07-19 | Ardelyx | Regulatory Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis ardelyx.com ↗
The company immediately requested a meeting to discuss the deficiencies and was notified by the FDA today that the request for a meeting was denied. |
| 2021-06-07 | Ardelyx | Results Ardelyx Announces Presentations at ERA-EDTA Virtual Congress 2021 ardelyx.com ↗
In a separate presentation, the company reported that patients who were on tenapanor had a smaller percentage of deaths and hospitalizations than those on the phosphate binder, sevelamer, in the long-term Phase 3 PHREEDOM study. |
| 2021-04-29 | Ardelyx | Regulatory Ardelyx Announces Extension of the PDUFA Review Period for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis ardelyx.com ↗
In response, the company submitted the requested analyses which constitute a major amendment to the New Drug Application (NDA), resulting in an extension of the PDUFA date by three months to July 29, 2021 . |
| 2020-11-05 | Ardelyx | Regulatory Ardelyx Reports Third Quarter 2020 Financial Results and Business Highlights ardelyx.com ↗
Tenapanor NDA Accepted for Review by FDA |
| 2020-10-23 | Kyowa Kirin, Inc. | Results Ardelyx and Kyowa Kirin Highlight New Data Supporting the Clinical Safety and Efficacy of First-In-Class, Phosphate Absorption Inhibitor Tenapanor at ASN's Kidney Week 2020 Data presented across five posters continue to support the foundational role tenapanor could play in the treatment of hyperphosphatemia Exhibitor Spotlight presentation highlights advances in the science of phosphate absorption kyowakirin.com ↗ |
| 2020-10-22 | Ardelyx | Results Ardelyx and Kyowa Kirin Highlight New Data Supporting the Clinical Safety and Efficacy of First-In-Class, Phosphate Absorption Inhibitor Tenapanor at ASN's Kidney Week 2020 ardelyx.com ↗
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company developing targeted, first-in-class medicines to improve the lives of patients with kidney and cardiovascular diseases, and Kyowa Kirin Co., Ltd. ( Kyowa Kirin , TSE: 4151) today highlighted new clinical data presented within five posters at Kidney Week 2020 , this year's virtual Annual Meeting of the American Society of Nephrology (ASN) that is now underway. |
| 2020-09-15 | Ardelyx | Regulatory Ardelyx Announces FDA Acceptance for Filing of its New Drug Application of Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis ardelyx.com ↗
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) of tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. |
| 2020-06-30 | Ardelyx | Regulatory Ardelyx Announces Submission of New Drug Application to the U.S. FDA for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis ardelyx.com ↗ |
| 2020-06-15 | Ardelyx | Results Ardelyx Announces Positive Second Data Analysis from Ongoing NORMALIZE Phase 4 Study Evaluating Tenapanor in CKD Patients on Dialysis ardelyx.com ↗
Foundational use of tenapanor as monotherapy or with sevelamer enabled up to 47.4% of patients to achieve normal serum phosphorus levels (<4.6 mg/dL), a 58% improvement over current standard of care |
| 2020-06-08 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces a Phase 2 Study Result of tenapanor (KHK7791) for Hemodialysis Patients with Hyperphosphatemia in Japan Presented at European Renal Association-European Dialysis and Transplant Association kyowakirin.com ↗
The primary endpoint was met. |
| 2019-12-03 | Ardelyx | Results Ardelyx Announces Positive Topline Results from Pivotal Phase 3 PHREEDOM Study Evaluating Tenapanor in CKD Patients on Dialysis ardelyx.com ↗
The PHREEDOM study met its primary endpoint demonstrating a statistically significant difference in least square (LS) mean serum phosphorus change (-1.4 mg/dL, p<0.0001), as compared to placebo. |
| 2019-09-12 | Ardelyx | Regulatory Ardelyx Receives FDA Approval for IBSRELA® (Tenapanor), an NHE3 Sodium Transport Inhibitor, for the Treatment of Irritable Bowel Syndrome with Constipation ardelyx.com ↗ |
| 2019-09-03 | Ardelyx | Results Ardelyx Announces Positive Results from the Pivotal Phase 3 AMPLIFY Study Evaluating Tenapanor in Dialysis Patients Who Have Uncontrolled Hyperphosphatemia Despite Phosphate Binder Treatment ardelyx.com ↗
The AMPLIFY study met the primary endpoint and all key secondary endpoints, including demonstrating a statistically significant (p=0.0004) reduction in serum phosphorus levels for patients treated with tenapanor and phosphate binders compared to phosphate binders alone. |
| 2019-03-07 | Ardelyx | Results Ardelyx Announces Peer-Reviewed Publication of Positive Phase 3 Results of Tenapanor for the Treatment of Hyperphosphatemia in the Journal of the American Society of Nephrology ardelyx.com ↗
The data demonstrated that there were significant decreases in serum phosphate in all three treatment groups, with mean reduction of 1.0-1.2 mg/dL over 8 weeks (all P < 0.001). |
| 2018-11-13 | Ardelyx | Regulatory Ardelyx Announces FDA Acceptance of the Filing of its New Drug Application for Tenapanor for the Treatment of Patients with IBS-C ardelyx.com ↗
FREMONT, Calif. , Nov. 13, 2018 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), today announced that the U.S. Food and Drug Administration ( FDA ) has accepted for review the New Drug Application (NDA) for tenapanor for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). |
| 2018-10-26 | Ardelyx | Results Ardelyx Presents New Preclinical Data Demonstrating Synergy between Tenapanor and Sevelamer When Dosed in Combination for Elevated Serum Phosphorus ardelyx.com ↗
The data, showing that the combination meaningfully reduced serum phosphorus, were presented today in a poster titled "Combination treatment with tenapanor and sevelamer synergistically reduces urinary phosphorus excretion in rats," at the American Society of Nephrology (ASN) Annual Meeting. |
| 2018-10-08 | Ardelyx | Results Ardelyx Showcases New Data from T3MPO-3 Long-Term Safety Trial of Tenapanor for IBS-C in Presidential Poster at ACG 2018 Annual Meeting ardelyx.com ↗
FREMONT, Calif. , Oct. 8, 2018 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), today announced that new data from its long-term safety trial of tenapanor for irritable bowel syndrome with constipation (IBS-C), the T3MPO-3 trial, were presented this weekend at the American College of Gastroenterology (ACG) 2018 Annual Meeting. |
| 2018-09-13 | Ardelyx | Regulatory Ardelyx Submits New Drug Application for U.S. Marketing Authorization of Tenapanor for IBS-C to U.S. Food and Drug Administration ardelyx.com ↗
today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) requesting U.S. marketing authorization of tenapanor for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). |
| 2018-01-03 | Ardelyx | Results Ardelyx Successfully Completes T3MPO-3 Safety Extension Study of Tenapanor for IBS-C ardelyx.com ↗
Results from T3MPO-3 showed a mean tenapanor compliance rate of approximately 98 percent, and that tenapanor was well-tolerated among the 240 patients treated. |
| 2017-10-16 | Ardelyx | Results Ardelyx Announces Tenapanor Reduces Pain Caused by IBS-C Through Inhibition of TRPV-1 Signaling ardelyx.com ↗ |
| 2017-10-11 | Ardelyx | Results Ardelyx's Pivotal Phase 3 Study of Tenapanor for IBS-C Hits Primary and All Secondary Endpoints to Support NDA Submission in 2018 ardelyx.com ↗
Ardelyx, Inc. (NASDAQ: ARDX) today reported positive results from T3MPO-2, its second Phase 3 study of tenapanor for irritable bowel syndrome with constipation (IBS-C). |
| 2017-05-12 | Ardelyx | Results Ardelyx Reports Successful Phase 3 T3MPO-1 Trial of Tenapanor in Patients with IBS-C ardelyx.com ↗
The T3MPO-1 trial achieved statistical significance for the primary endpoint and seven of eight secondary endpoints. |
| 2017-02-15 | Ardelyx | Results Ardelyx Announces Successful Phase 3 Trial of Tenapanor for Hyperphosphatemia in Patients with End-Stage Renal Disease ardelyx.com ↗
Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage company focused on enhancing the treatment of patients with cardiorenal and gastrointestinal (GI) diseases, today reported that the Phase 3 clinical trial evaluating the efficacy and safety of tenapanor as a treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis met its primary endpoint and was generally well-tolerated. |
| 2016-10-19 | Ardelyx | Results Ardelyx Announces the Presentation of Positive Global Endpoint Findings from Phase 2b Trial of Tenapanor in Patients with IBS-C at ACG Annual Meeting ardelyx.com ↗
In this methodologically rigorous Phase 2b trial, 50 mg of tenapanor twice a day provided robust benefits for the key symptoms of IBS-C, including abdominal pain and stool frequency, compared to placebo, |
| 2015-05-19 | Ardelyx | Results Ardelyx Presents Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients at Digestive Disease Week 2015 ardelyx.com ↗
today presented Phase 2b clinical trial results that demonstrated statistically significant and clinically meaningful improvement in IBS-C symptoms for tenapanor-treated patients compared to patients receiving placebo. |
| 2015-05-05 | Ardelyx | Results Ardelyx Reports Results from Phase 2a Clinical Trial Evaluating Tenapanor in Chronic Kidney Disease Patients with Type 2 Diabetes Mellitus and Albuminuria ardelyx.com ↗
did not meet the primary endpoint of decreasing the urinary albumin-creatinine ratio in tenapanor-treated patients compared to patients receiving placebo. |
| 2015-02-02 | Ardelyx | Results Ardelyx Reports Results from Phase 2b Clinical Trial Evaluating Tenapanor in Treating Hyperphosphatemia in Chronic Kidney Disease Patients on Hemodialysis ardelyx.com ↗
It was noted, however, that the rate of diarrhea was distinctly higher than expected. |
| 2014-11-17 | Ardelyx | Results Ardelyx's Tenapanor Reduces Phosphorus Absorption and Protects against Vascular Calcification in Preclinical In Vivo Model of Chronic Kidney Disease ardelyx.com ↗
According to the research findings reported in JASN, tenapanor decreased phosphorous absorption in rats, both in a setting of normal renal function and in a model of CKD. |
| 2014-10-23 | Ardelyx | Results Ardelyx's Tenapanor Selected for Oral and Poster Presentations at the American Society of Nephrology's Kidney Week 2014 ardelyx.com ↗
Tenapanor, a Minimally Absorbed NHE3 Inhibitor, Reduces Dietary Phosphorus Absorption in Healthy Volunteers |
| 2014-10-01 | Ardelyx | Results Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients ardelyx.com ↗
Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal and metabolic diseases, today announced positive results from its 371 patient Phase 2b clinical trial evaluating tenapanor in patients with constipation-predominant irritable bowel syndrome (IBS-C). |
| 2012-05-24 | Ardelyx | Results Ardelyx will present at the 22nd European Meeting on Hypertension and Cardiovascular Protection in London (UK) April 26-29, 2012 ardelyx.com ↗
RDX5791, A NON-SYSTEMIC NHE3 INHIBITOR, ALONE OR IN COMBINATION WITH ENALAPRIL, PREVENTS CARDIOVASCULAR AND RENAL DYSFUNCTION IN SALT FED RATS WITH RENAL INSUFFICIENCY |
All press releases naming this drug 112 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 112 releases opens the full record — a long page | ||
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 NCT02727751 ↗ |
| 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 NCT02249936 ↗ |
| 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 NCT03864445 ↗ |
| Known as | RDX5791 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02796131 ↗ |
| 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 |