XPHOZAH® (tenapanor)
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Real-World Evidence Studies of XPHOZAH® (tenapanor) Demonstrate Patient Satisfaction and Reduction in Serum Phosphate with XPHOZAH in Data Presented at ASN Kidney Week
Globenewswire· 2025-11-07 21:05
Core Insights - Ardelyx, Inc. presented data on XPHOZAH at the American Society of Nephrology's Kidney Week, highlighting its effectiveness in real-world settings for patients with chronic kidney disease on dialysis [1][3] Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on developing innovative medicines to address significant unmet medical needs [1][15] - The company has two commercial products approved in the United States: IBSRELA and XPHOZAH, with ongoing development of next-generation therapies [15][16] Product Information - XPHOZAH is the first phosphate absorption inhibitor approved by the FDA for reducing serum phosphorus in adults with chronic kidney disease on dialysis [2][14] - It is administered as a single tablet taken twice daily and works by blocking phosphate absorption in the gut [2][10] Clinical Study Results - The first real-world study of XPHOZAH showed that patients experienced an average reduction in serum phosphate of nearly 1 mg/dL, with 45.3% of participants achieving a reduction of ≥1 mg/dL [3][4] - A separate survey indicated that 63% of patients reported improved phosphate levels since starting tenapanor, with 69% feeling better about their phosphate control [4] Patient Experience - Positive patient experiences were reported, including improved bowel movements and lower pill burden, with 44% attributing improvements to better phosphate control [4] - Tenapanor also demonstrated effectiveness in improving bowel movements in patients with end-stage kidney disease and constipation [6][7] Economic Analysis - A cost-effectiveness analysis in Japan concluded that tenapanor is cost-effective for hemodialysis patients, meeting the threshold of five million Japanese Yen for willingness to pay [8]
Ardelyx to Participate at the Jefferies Global Healthcare Conference in London
Globenewswire· 2025-11-05 13:00
Core Insights - Ardelyx, Inc. is participating in a fireside chat at the Jefferies Global Healthcare Conference in London on November 19, 2025 [1] - The company focuses on discovering, developing, and commercializing innovative medicines to address significant unmet medical needs [3] Company Overview - Ardelyx has two commercial products approved in the United States: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) [3] - The company is developing RDX10531, a next-generation NHE3 inhibitor with potential applications across multiple therapeutic areas [3] - Ardelyx has international agreements for the commercialization of tenapanor, including partnerships with Kyowa Kirin in Japan and Fosun Pharma in China [3] - Knight Therapeutics is responsible for commercializing IBSRELA in Canada [3]
Ardelyx President and Chief Executive Officer Mike Raab to Participate in the Wedbush Rewind American Society of Nephrology 2025 Investor Conference
Globenewswire· 2025-11-04 13:00
Core Insights - Ardelyx, Inc. is focused on discovering, developing, and commercializing innovative medicines to address significant unmet medical needs [3] Company Overview - Ardelyx has two commercial products approved in the United States: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) [3] - The company is developing RDX10531, a next-generation NHE3 inhibitor with potential applications across multiple therapeutic areas [3] - Ardelyx has international agreements for the development and commercialization of tenapanor, including partnerships with Kyowa Kirin in Japan and Fosun Pharma in China [3] - Knight Therapeutics is responsible for commercializing IBSRELA in Canada [3] Upcoming Events - The President and CEO of Ardelyx, Mike Raab, will participate in a fireside chat at the Wedbush Rewind ASN 2025 Conference on November 10, 2025 [1] - A public webcast of the event will be available on the Ardelyx website, with a replay accessible for 30 days post-event [2]
Ardelyx to Report Second Quarter 2025 Financial Results on August 4, 2025
GlobeNewswire News Room· 2025-07-21 12:00
Core Insights - Ardelyx, Inc. is set to hold a conference call on August 4, 2025, to discuss its financial results and provide a business update for Q2 2025 [1] Company Overview - Ardelyx is a biopharmaceutical company focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [3] - The company has two commercial products approved in the U.S.: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) [3] - Ardelyx has international agreements for the development and commercialization of tenapanor, including partnerships with Kyowa Kirin in Japan and Fosun Pharma in China [3] - Knight Therapeutics is responsible for commercializing IBSRELA in Canada [3]
Ardelyx Appoints Merdad Parsey, M.D., Ph.D. to its Board of Directors
GlobeNewswire News Room· 2025-04-29 12:00
Core Insights - Ardelyx, Inc. has appointed Merdad Parsey, M.D., Ph.D. to its board of directors, enhancing its leadership team with a veteran biotech expert [1][2] Company Overview - Ardelyx is focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [4] - The company has two commercial products approved in the U.S.: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor), along with early-stage pipeline candidates [4] - Ardelyx has international agreements for the development and commercialization of tenapanor, including partnerships with Kyowa Kirin in Japan and Fosun Pharma in China [4] Leadership Experience - Dr. Parsey brings over 25 years of experience in the pharmaceutical and biopharma industries, having held various clinical development and leadership roles [2][3] - His recent position was Chief Medical Officer at Gilead Sciences from 2019 until his retirement in 2025 [2] - Dr. Parsey has also served in senior roles at Genentech and as CEO of 3-V Biosciences, contributing to his extensive expertise in clinical strategy and development [2] Educational Background - Dr. Parsey holds a B.S. in microbiology and biochemistry, an M.D., and a Ph.D. in immunology from the University of Maryland [3] - He completed his internal medicine residency at Stanford University and a fellowship in pulmonary and critical care at the University of Colorado [3]
Ardelyx to Share a Post-Hoc Analysis of the OPTIMIZE Study Supporting XPHOZAH® (tenapanor) at the National Kidney Foundation Spring Clinical Meetings
Globenewswire· 2025-03-31 20:03
Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [1][12] - The company has two commercial products approved in the United States: IBSRELA and XPHOZAH, both containing the active ingredient tenapanor [12] Product Information - XPHOZAH (tenapanor) is the first and only phosphate absorption inhibitor (PAI) approved by the U.S. FDA for reducing serum phosphorus in adults with chronic kidney disease (CKD) on dialysis [2][11] - It is indicated as add-on therapy for patients who have an inadequate response to phosphate binders or are intolerant to any dose of phosphate binder therapy [11] - XPHOZAH operates through a unique mechanism that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily [2][6] Clinical Study Insights - The OPTIMIZE Study was a randomized, open-label trial involving 330 patients with CKD on dialysis and hyperphosphatemia, aimed at evaluating methods for initiating XPHOZAH to optimize phosphorus management [3] - A post-hoc analysis of this study has been accepted for presentation at the National Kidney Foundation Spring Clinical Meetings [1][4] Safety and Efficacy - Diarrhea was the most common side effect reported in clinical trials, occurring in 43-53% of patients, with severe diarrhea reported in 5% of patients [10] - The majority of diarrhea events were mild-to-moderate and typically resolved over time or with dose reduction [10] Industry Context - Hyperphosphatemia is a serious condition affecting the majority of the 550,000 patients in the U.S. with CKD on maintenance dialysis, necessitating effective management strategies [7] - The KDIGO treatment guidelines recommend lowering elevated phosphate levels toward the normal range of 2.5-4.5 mg/dL [7]