Ardelyx Announces Upcoming Data Presentation at ISN World Congress of Nephrology 2021

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Ardelyx, Inc. (Nasdaq: ARDX) announced the presentation of a poster at the ISN World Congress of Nephrology 2021, highlighting data from its NORMALIZE Phase 4 trial. This study evaluates the efficacy of tenapanor alone or with sevelamer in achieving normal serum phosphorus levels in chronic kidney disease patients on dialysis. The virtual event will occur from April 16-19, 2021. Additionally, Ardelyx is advancing tenapanor for FDA review, with a PDUFA date of April 29, 2021, and has received FDA approval for IBSRELA (tenapanor) on September 12, 2019.

FREMONT, Calif. and WALTHAM, Mass., April 12, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that it will present a poster highlighting data from NORMALIZE, an ongoing Phase 4 trial designed to evaluate the ability of tenapanor  alone or in combination with sevelamer to achieve normal serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis at the ISN World Congress of Nephrology 2021, which will take place virtually April 16-19, 2021.

Details on Ardelyx's poster:

Abstract Title:  A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination with Sevelamer to Achieve Normal Serum Phosphorus in Patients with CKD on Dialysis (NORMALIZE)
Authors: David P. Rosenbaum, Yang Yang, Arnold Silva, German T. Hernandez, Geoffrey A. Block
Abstract number: WCN21-0374

For more information on these and other abstracts, please visit the ISN World Congress of Nephrology 2021 website.  

About Ardelyx, Inc.
Ardelyx is focused on discovering, developing, and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company's NDA is currently under review by the FDA, with a PDUFA date of April 29, 2021. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. In addition, Ardelyx received FDA approval of IBSRELA^® (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.

 

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SOURCE Ardelyx

FAQ

What is the NORMALIZE trial presented by Ardelyx at ISN World Congress of Nephrology 2021?

The NORMALIZE trial is a Phase 4 study evaluating the ability of tenapanor alone or in combination with sevelamer to achieve normal serum phosphorus levels in chronic kidney disease patients on dialysis.

When is the ISN World Congress of Nephrology 2021 taking place?

The ISN World Congress of Nephrology 2021 is scheduled for April 16-19, 2021, and will be held virtually.

What is the significance of the PDUFA date for Ardelyx's tenapanor?

The PDUFA date for Ardelyx's tenapanor is April 29, 2021, which is when the FDA will decide on the New Drug Application for this treatment.

When was IBSRELA (tenapanor) approved by the FDA?

IBSRELA (tenapanor) was approved by the FDA on September 12, 2019.