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Ardelyx

Biotech & Life Sciences · Fremont, United States · Founded 2007 · IPO 2014

Ardelyx, Inc. is a biopharmaceutical company founded in October 2007 by Dominique Charmot, Peter G. Schultz, and Jean M. Frechet, with a focus on developing and commercializing treatments for cardiorenal and gastrointestinal diseases. The company operates on a business model that integrates drug discovery, clinical development, and commercialization, generating revenue through direct product sales, licensing agreements, and strategic partnerships. The company's President and CEO, Mike Raab, joined in 2009 from New Enterprise Associates (NEA), a venture capital firm. His prior experience includes serving as senior vice president at Genzyme Corporation, where he was instrumental in launching and growing the sales of sevelamer, a leading phosphate binder. This background in the renal field is directly relevant to Ardelyx's focus. Ardelyx has two commercial products in the United States, both based on its lead compound, tenapanor. Tenapanor is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), which reduces the absorption of sodium and phosphate in the gut. This first-in-class mechanism allows for targeted treatment with minimal systemic absorption. One of its key products is IBSRELA® (tenapanor), a twice-daily, 50 mg oral tablet for adults with Irritable Bowel Syndrome with Constipation (IBS-C). It works by increasing water secretion into the intestinal lumen, which accelerates transit time and alleviates symptoms like constipation, bloating, and abdominal pain, with relief often starting within the first week. The other commercial product is XPHOZAH® (tenapanor), a twice-daily tablet indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. It is approved as an add-on therapy for patients who have an inadequate response to or are intolerant of phosphate binders. By inhibiting NHE3, XPHOZAH blocks the paracellular pathway of phosphate absorption, offering a different approach to managing hyperphosphatemia, a common condition in dialysis patients. Ardelyx pursues global market penetration through strategic collaborations. In Japan, Kyowa Kirin commercializes tenapanor for hyperphosphatemia under the brand name PHOZEVEL®. Knight Therapeutics manages the commercialization of IBSRELA in Canada, and Fosun Pharma has submitted a New Drug Application for tenapanor for hyperphosphatemia in China. Keywords: Ardelyx, tenapanor, biopharmaceutical, cardiorenal diseases, gastrointestinal diseases, IBSRELA, XPHOZAH, hyperphosphatemia, chronic kidney disease, CKD, irritable bowel syndrome with constipation, IBS-C, NHE3 inhibitor, phosphate absorption inhibitor, drug development, Mike Raab, Dominique Charmot, Peter G. Schultz, Kyowa Kirin, Knight Therapeutics, Fosun Pharma