IBSRELA® (tenapanor)

Search documents
Ardelyx to Report Second Quarter 2025 Financial Results on August 4, 2025
GlobeNewswire News Room· 2025-07-21 12:00
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has be ...
Ardelyx Presents Data Supporting IBSRELA® (tenapanor) at Digestive Disease Week 2025 Conference
Globenewswire· 2025-05-06 12:01
Core Insights - Ardelyx, Inc. presented data on IBSRELA (tenapanor) and findings from the IBS in America 2024 Real-World Survey at the Digestive Disease Week Conference, highlighting the correlation between IBS-C symptom severity and financial hardship [1][2] Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on developing innovative medicines to address significant unmet medical needs, with two commercial products approved in the U.S.: IBSRELA and XPHOZAH [13] Product Information - IBSRELA (tenapanor) is approved by the FDA for treating irritable bowel syndrome with constipation (IBS-C) in adults, acting as a sodium/hydrogen exchanger 3 (NHE3) inhibitor to improve intestinal transit and stool consistency [1][6][12] - The drug has shown efficacy in reducing abdominal pain and improving gastrointestinal symptoms in clinical studies [6] Survey Findings - The IBS in America 2024 Real-World Survey revealed that higher severity of IBS-C symptoms is linked to increased financial burden, assessed using the Functional Assessment of Chronic Illness Therapy Measure of Financial Toxicity (FACIT-COST®) [2] - The survey utilized Patient-Reported Outcomes Measurement Information System® (PROMIS®) gastrointestinal symptom scales to evaluate the impact of IBS on patients' quality of life [2] Safety and Tolerability - Interim results from a Phase 3 study indicated that tenapanor was well-tolerated in pediatric patients aged 12 to 18, with diarrhea being the only adverse event related to the drug [3] - A separate pharmacokinetic study found that tenapanor and its major metabolite were not detectable in the breast milk of lactating females after four days of dosing, indicating a favorable safety profile [4] Market Context - IBS-C affects an estimated 12 million people in the U.S., leading to significant economic burden and impaired quality of life, highlighting the need for effective treatments like IBSRELA [7]
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]