[{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyowa Kirin Announces a Phase 2 Study Result of tenapanor (KHK7791) for Hemodialysis Patients with Hyperphosphatemia in Japan","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase II"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces Positive Second Data Analysis from Ongoing NORMALIZE Phase 4 Study Evaluating Tenapanor in CKD Patients on Dialysis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces Submission of New Drug Application to the U.S. FDA for Tenapanor","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces FDA Acceptance for Filing of its NDA of Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces Data Supporting Efficacy and Safety of Tenapanor to be Presented at ASN's Kidney Week 2020","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx and Kyowa Kirin Highlight New Data Supporting the Clinical Safety and Efficacy of Tenapanor at ASN's Kidney Week 2020","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Provides Corporate Update Following Type A Meeting with FDA","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Launching IBSRELA Second Quarter of 2022","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces US Launch of IBSRELA\u00ae, a New First-in-Class Treatment for IBS-C in Adults","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces FDA Plan to Convene Advisory Committee for XPHOZAH\u00ae (tenapanor)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces Additional Data Supporting the Efficacy and Safety of First-In-Class IBSRELA\u00ae (tenapanor) for Adults with IBS-C, to be Presented at DDW 2022","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Presents Data at DDW 2022 on IBSRELA\u00ae (tenapanor), a First-In-Class Treatment for IBS-C in Adults","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"},{"orgOrder":0,"company":"Ardelyx","sponsor":"HealthCare Royalty Partners","pharmaFlowCategory":"D","amount":"$20.0 million","upfrontCash":"$10.0 million","newsHeadline":"Ardelyx Announces $20 Million Financing Agreement with HealthCare Royalty Partners","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces FDA Advisory Committee Meeting to Review XPHOZAH\u00ae NDA Tentatively Scheduled for November 16, 2022","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"D","amount":"$520.5 million","upfrontCash":"$10.5 million","newsHeadline":"Ardelyx Collaboration Partner, Kyowa Kirin, Announces Submission of New Drug Application for Tenapanor for Hyperphosphatemia in Japan","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Presents New Data Analyses at Kidney Week 2022, Further Supporting the Clinical Relevance of XPHOZAH\u00ae (tenapanor), an Investigational, Phosphate Absorption Inhibitor to Control Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dial","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Provides Update on FDA Appeal for XPHOZAH\u00ae (tenapanor) for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase IV"}]
Find Clinical Drug Pipeline Developments & Deals by Ardelyx
Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials.
XPHOZAH (tenapanor),is an investigational first-in-class phosphate absorption inhibitor, With its unique blocking MOA, XPHOZAH acts locally in gut, reducing phosphate absorption through paracellular pathway, primary pathway of phosphate absorption.
Under the terms of the agreement, Ardelyx will execute a research plan to advance two of Ardelyx’s ongoing research programs focused on the identification and design of Tenapanor (xphozah), a phosphate absorption inhibitor, for the treatment of Hyperphosphatemia.
HealthCare Royalty Partners funding supports the ongoing launch of IBSRELA® (tenapanor) in the United States in exchange for future hyperphosphatemia royalty payments from Ardelyx Japanese collaboration partner.
XPHOZAH (tenapanor), an investigational first-in-class phosphate absorption inhibitor. XPHOZAH, with its unique blocking mechanism of action, acts locally in the gut to inhibit the sodium hydrogen exchanger 3, reducing phosphate absorption through the paracellular pathway.
IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium.
IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium.
XPHOZAH (tenapanor), an investigational first-in-class phosphate absorption inhibitor, with its unique blocking mechanism of action, acts locally in gut to inhibit NaOH exchanger, reducing phosphate absorption through paracellular pathway.
IBSRELA®(tenapanor) is the first and only NHE3 Inhibitor FDA approved for the treatment of IBS-C in adults, reported 41% improvement in quality of life score from baseline to end of treatment, and vast majority of patients reported satisfaction with treatment.
The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats, decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor.