Clinical Trials
At Ardelyx, we are steadfast in our commitment to deliver first-in-class medicines to patients with unmet medical needs.
What is a clinical trial?
A clinical trial is a research study conducted in people to test the efficacy and safety of a medication. Clinical trials occur after testing has been completed in non-human subjects and no safety concerns are found.
Before a trial begins, a protocol must be approved by the U.S. Federal Drug Administration and an ethical review board to ensure the appropriate people are included in the study and that they face the lowest risk possible.
Clinical trials are crucial for advancing medical knowledge and improving patient care by providing evidence-based insights. They involve collaboration between researchers, healthcare professionals, and willing participants, playing a pivotal role in shaping the future of medicine.
Our Trials
We are grateful to all the individuals and families helping us advance our research through their participation in our clinical trials. Each person’s participation contributes greatly to our knowledge of the diseases we treat and can impact patients.
Learn more about ongoing, Ardelyx-sponsored clinical trials below.
R-ALLY
Active, Recruiting
A Phase 3 study to assess the efficacy and safety of tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C) in pediatric patients 12 to less than 18 years old.
Lactation Study
Active, Not Recruiting
An open label Phase 1 study to investigate pharmacokinetics of tenapanor and AZ13792925 in breast milk of lactating female subjects.
If you have questions, please email us at medinfo@ardelyx.com.
Diversity, Equity, & Inclusion in Clinical Trials
We recognize that ensuring diversity, equity, and inclusion in clinical trials is ethical and essential for developing safe and efficacious treatments for all. We recruit participants who represent those most affected by the diseases we aim to treat. This approach ensures that we gain an authentic understanding of treatment effectiveness and safety concerns across relevant populations.
Additionally, we are committed to ensuring that the participants in our trials represent the diverse demographic makeup of the real-world patient population.
Medicines
Ardelyx was founded to discover, develop, and commercialize first-in-class, novel mechanism therapies that address significant unmet medical needs.
Commitment to Patients
We believe in working closely with patients and their caregivers, listening to their needs and insights, and setting new standards in product innovation and community engagement.