FDA Events for Ardelyx (ARDX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Ardelyx (ARDX).
Over the past two years, Ardelyx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
tenapanor. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
tenapanor - FDA Regulatory Timeline and Events
tenapanor is a drug developed by Ardelyx for the following indication: Control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- tenapanor
- Announced Date:
- May 6, 2025
- Indication:
- Control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis
Announcement
Ardelyx, Inc. announced that the company presented data supporting the company's first-in-class retainagogue, IBSRELA® (tenapanor), as well as results from the IBS in America 2024 supplemental survey, at the Digestive Disease Week Conference (DDW), now underway in San Diego.
AI Summary
At the Digestive Disease Week Conference in San Diego, Ardelyx, Inc. presented important data on its first-in-class retainagogue, IBSRELA® (tenapanor). This presentation showcased new findings supporting IBSRELA’s role in the treatment of irritable bowel syndrome with constipation (IBS-C) in adults, following its approval by the FDA. The data highlights the drug’s effectiveness and safety, reinforcing its potential benefit for patients struggling with IBS-C symptoms.
In addition, Ardelyx shared insights from the IBS in America 2024 supplemental survey, which explores the real-world patient experience with IBS. The survey provided valuable information on how IBS-related symptoms affect quality of life and contribute to financial challenges for patients. Overall, these presentations underscore Ardelyx’s commitment to advancing treatment options and deepening the understanding of IBS and its impact on patients.
Read Announcement- Drug:
- tenapanor
- Announced Date:
- April 24, 2025
- Indication:
- Control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis
Announcement
Ardelyx, Inc. announced that the company will present data supporting the company's first-in-class retainagogue, IBSRELA® (tenapanor), as well as results from the IBS in America 2024 supplemental survey, at the upcoming Digestive Disease Week Conference (DDW), to be held May 3-6, 2025, in San Diego.
AI Summary
Ardelyx, Inc. announced exciting plans to share new clinical data at the upcoming Digestive Disease Week Conference (DDW) in San Diego, May 3–6, 2025. The company will present research supporting its first-in-class retainagogue, IBSRELA® (tenapanor), which is approved by the U.S. Food and Drug Administration for treating irritable bowel syndrome with constipation (IBS-C) in adults. At DDW, Ardelyx will also showcase findings from the IBS in America 2024 supplemental survey that provide insights into patient-reported outcomes and financial impacts associated with IBS-C symptom severity. The presentations will include multiple poster sessions and an interactive Product Theater session featuring key clinical perspectives on managing the condition, highlighting IBSRELA’s innovative mechanism that retains luminal water and improves intestinal transit. This event underscores the company’s commitment to advancing treatments for significant unmet medical needs.
Read Announcement- Drug:
- tenapanor
- Announced Date:
- March 31, 2025
- Indication:
- Control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis
Announcement
Ardelyx, Inc. announced that an abstract detailing a post-hoc analysis of the OPTIMIZE Study, an open-label clinical trial of XPHOZAH ® (tenapanor), was accepted as a poster presentation at the National Kidney Foundation (NKF) Spring Clinical Meetings, to be held April 10-13, 2025, in Boston.
AI Summary
Ardelyx, Inc. announced that an abstract from a post-hoc analysis of the OPTIMIZE Study has been accepted for a poster presentation at the upcoming National Kidney Foundation Spring Clinical Meetings in Boston, scheduled for April 10–13, 2025. The analysis focused on data from an open-label clinical trial of XPHOZAH® (tenapanor), a phosphate absorption inhibitor approved to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. The abstract, titled “Tenapanor-Treated Patients Using Over-the-Counter Antidiarrheal Agents Saw Decreased Stool Frequency and Improved Stool Consistency,” evaluates how the use of over-the-counter antidiarrheal medications with tenapanor may affect stool consistency and frequency. The poster is set to be presented on April 10, 2025, from 5:15 to 7:30 PM EDT, offering valuable insights for optimizing phosphorus management in this patient population.
Read Announcement- Drug:
- tenapanor
- Announced Date:
- October 9, 2024
- Indication:
- Control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis
Announcement
Ardelyx, Inc. announced the recent publication of a review article, titled "Review of the Patient Burden and Therapeutic Landscape of Irritable Bowel Syndrome With Constipation in the United States" in Clinical and Experimental Gastroenterology, an international, peer reviewed, open access journal focusing on all aspects of gastroenterology research, as well as clinical results in human, animal and in vitro studies that shed light on disease processes and potential new therapies.
AI Summary
Ardelyx, Inc. recently published a review article titled "Review of the Patient Burden and Therapeutic Landscape of Irritable Bowel Syndrome With Constipation in the United States" in the international, peer-reviewed, open access journal Clinical and Experimental Gastroenterology. The article provides an overview of the challenges faced by patients with IBS-C and examines the wide range of treatment options currently available in the U.S.
The review discusses the heavy impact IBS-C has on patients, not only physically but also economically, socially, and mentally. It emphasizes the importance of a strong relationship between patients and healthcare providers in diagnosing and treating the condition. The article outlines a positive diagnostic approach based on clinical history, physical exams, and minimal laboratory tests, while also covering the treatment journey from lifestyle changes to using FDA-approved therapies like IBSRELA® (tenapanor) for managing IBS-C.
Read Announcement- Drug:
- tenapanor
- Announced Date:
- July 2, 2024
- Indication:
- Control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis
Announcement
Ardelyx, Inc announced that, in an effort to preserve patient access to its phosphate absorption inhibitor XPHOZAH® (tenapanor), the Company has chosen not to apply to include XPHOZAH in the Centers for Medicare & Medicaid Services (CMS) End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Transitional Drug Add-on Payment Adjustment (TDAPA).
AI Summary
Ardelyx, Inc. announced it will not seek to include its phosphate absorption inhibitor XPHOZAH® (tenapanor) in the CMS End-Stage Renal Disease Prospective Payment System (ESRD PPS) Transitional Drug Add-on Payment Adjustment (TDAPA). According to Ardelyx, CMS’s planned policy for including oral-only medications could severely limit the use of XPHOZAH by restricting how healthcare professionals and patients decide on treatment options. The company’s analysis shows that such restrictions during the TDAPA period might effectively eliminate patient access to XPHOZAH, a medicine proven to help reduce elevated serum phosphorus levels in adults with chronic kidney disease on dialysis. Ardelyx is now supporting bipartisan legislation that would extend the current exclusion of oral-only medications from the Medicare ESRD PPS, ensuring that patients continue to have access to innovative treatment options like XPHOZAH.
Read Announcement
Ardelyx FDA Events - Frequently Asked Questions
As of now, Ardelyx (ARDX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Ardelyx (ARDX) has reported FDA regulatory activity for tenapanor.
The most recent FDA-related event for Ardelyx occurred on May 6, 2025, involving tenapanor. The update was categorized as "Data Presentation," with the company reporting: "Ardelyx, Inc. announced that the company presented data supporting the company's first-in-class retainagogue, IBSRELA® (tenapanor), as well as results from the IBS in America 2024 supplemental survey, at the Digestive Disease Week Conference (DDW), now underway in San Diego."
Currently, Ardelyx has one therapy (tenapanor) targeting the following condition: Control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ARDX) was last updated on 7/12/2025 by MarketBeat.com Staff
