Ardelyx (NASDAQ:ARDX) is a clinical-stage biopharmaceutical company headquartered in Fremont, California, dedicated to developing and commercializing novel treatments for patients with kidney and gastrointestinal diseases. Since its founding in 2004, Ardelyx has focused on therapies that target the underlying mechanisms of disease by modulating ion transport in the gut and kidneys. The company’s research efforts have led to the identification of innovative small-molecule candidates designed to address significant unmet medical needs in chronic kidney disease (CKD) and related metabolic disorders.
The company’s first approved therapy, XPHOZAH™ (tenapanor), received U.S. Food and Drug Administration approval in December 2021 for the control of serum phosphorus in adult patients with CKD on dialysis. Tenapanor acts by inhibiting the gastrointestinal sodium/hydrogen exchanger NHE3, reducing intestinal phosphate absorption. Beyond this indication, Ardelyx is advancing tenapanor through late-stage clinical trials in patients with irritable bowel syndrome with constipation (IBS-C) and exploring its use in CKD patients not yet requiring dialysis. In addition to tenapanor, Ardelyx has several early-stage programs, including novel compounds aimed at restoring electrolyte balance and improving gastrointestinal motility.
Ardelyx operates primarily in the United States but maintains collaborative partnerships to extend its reach globally. The company has entered into strategic alliances with pharmaceutical and biotechnology firms to support clinical development, regulatory submissions, and commercialization in key markets. These collaborations leverage Ardelyx’s expertise in ion transport biology alongside partners’ commercial infrastructure and regulatory experience, with the goal of delivering innovative therapies to patients worldwide.
The company is led by a seasoned management team with deep experience in biopharmaceutical research and commercialization. Chris Boerner, President and Chief Executive Officer, brings more than two decades of leadership in specialty pharmaceuticals, supported by a cadre of scientific, medical, and regulatory professionals. Ardelyx’s board and executive committee guide its strategy with a commitment to advancing science, maintaining rigorous safety standards, and ultimately improving the lives of patients suffering from kidney and gastrointestinal disorders.