Ardelyx, Inc. is a biopharmaceutical company, which engages in the business of developing and commercializing biopharmaceutical products. The firm is also involved in developing a unique and innovative platform that enables the discovery of new biological mechanisms and pathways to develop potent and efficacious therapies that minimize the side effects and drug-drug interactions frequently encountered with traditional, systemically absorbed medicines. The company was founded by Dominique Charmot, Peter G. Schultz, and Jean M. Frechet in October 2007 and is headquartered in Waltham, MA.
Clinical Trials
30
3 active
Approvals
7
Total approvals
Agencies
2
Regulatory bodies
Founded
2007
Active, not recruiting
2
6.7%
Completed
25
83.3%
Enrolling By Invitation
1
3.3%
Recruiting
1
3.3%
Terminated
1
3.3%
- Syntis Bio has dosed the first patient in its Phase 1/1b SYNTIETY-1 clinical trial of SYNT-101, a once-daily oral pill designed to mimic gastric bypass surgery effects for obesity treatment. - SYNT-101 works by blocking nutrient absorption in the duodenum and redirecting nutrients to stimulate natural secretion of satiety hormones including GLP-1, potentially preserving lean muscle mass. - The 28-day multi-ascending dose trial in Australia will evaluate safety, tolerability, and pharmacokinetics in healthy volunteers and overweight or obese patients. - The company strengthened its leadership team with the appointments of David Rosenbaum as Chief Development Officer and Christo Shalish as Chief Business Officer.
- Monopar Therapeutics appointed Susan Rodriguez as Chief Commercial and Strategy Officer to lead commercial strategy as the company prepares for a planned New Drug Application submission for ALXN1840 in the first half of 2026. - ALXN1840 represents the first major advancement in Wilson disease treatment in decades, with a novel mechanism of action as an albumin tripartite complex activator that differentiates it from current first-line therapies. - The company reported positive long-term efficacy and safety data from 255 patients with a median treatment duration of 2.63 years, demonstrating statistically significant improvement in copper balance. - Monopar strengthened its balance sheet with approximately $91.9 million raised through an underwritten public offering and expects current funds to support operations through at least December 31, 2027.
- Ardelyx has dosed the first patient in ACCEL, a Phase 3 clinical trial evaluating IBSRELA (tenapanor) for chronic idiopathic constipation in adults. - The multicenter, randomized, double-blind, placebo-controlled study aims to enroll approximately 700 patients over 26 weeks with topline data expected in the second half of 2027. - Chronic idiopathic constipation affects more than 34 million Americans and is associated with significantly impaired quality of life and high healthcare costs. - The trial represents Ardelyx's effort to expand IBSRELA's patient population beyond its current indication for irritable bowel syndrome with constipation.
- Ardelyx achieved approximately $378 million in total product revenue for 2025, with IBSRELA generating $274 million representing 73% growth compared to 2024. - The company projects IBSRELA revenue to reach $410-430 million in 2026 and expects to achieve $1 billion in revenue by 2029. - A Phase 3 clinical trial evaluating IBSRELA for chronic idiopathic constipation has commenced and is expected to complete in the second half of 2027. - Ardelyx received patent protection extending intellectual property coverage for both IBSRELA and XPHOZAH until December 2041.
- Avadel Pharmaceuticals has appointed Susan Rodriguez as Chief Operating Officer to lead commercial strategy and operations for LUMRYZ, the first once-at-bedtime oxybate treatment for narcolepsy. - Rodriguez brings over 30 years of life sciences experience, including leadership roles at Ardelyx, Tolmar Pharmaceuticals, and Abbott, with expertise in rare disease commercialization. - The appointment comes as Avadel scales to meet increasing patient demand for LUMRYZ and works toward potential label expansion to idiopathic hypersomnia. - LUMRYZ has received FDA approval for both adult and pediatric narcolepsy patients and holds 7 years of Orphan Drug Exclusivity due to clinical superiority over existing treatments.
- Fosun Pharma's Wan Ti Le (tenapanor hydrochloride tablets) has received NMPA approval for controlling serum phosphorus in dialysis patients with chronic kidney disease who have inadequate response to phosphate binders. - As the world's first and only approved phosphate absorption inhibitor, tenapanor works through a novel mechanism by inhibiting NHE3, reducing intestinal phosphate absorption through the paracellular pathway. - Clinical studies show tenapanor can decrease serum phosphate levels by an additional 0.57 mmol/L when combined with phosphate binders, potentially addressing the low phosphate control rates (39%) among China's one million hemodialysis patients.
