Ardelyx to Share a Post-Hoc Analysis of the OPTIMIZE Study Supporting XPHOZAH® (tenapanor) at the National Kidney Foundation Spring Clinical Meetings
Ardelyx (NASDAQ: ARDX) announced that a post-hoc analysis of their OPTIMIZE Study for XPHOZAH® (tenapanor) will be presented at the National Kidney Foundation Spring Clinical Meetings in April 2025. The study involved 330 patients with chronic kidney disease on dialysis with hyperphosphatemia.
XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is FDA-approved to reduce serum phosphorus in adult CKD patients on dialysis as an add-on therapy. It's specifically indicated for patients with inadequate response to phosphate binders or those intolerant to binder therapy. The medication is administered as a single tablet twice daily.
The poster presentation will focus on how tenapanor-treated patients using over-the-counter antidiarrheal agents experienced decreased stool frequency and improved stool consistency. Additionally, Ardelyx will sponsor an Exhibitor Showcase discussing hyperphosphatemia management strategies and XPHOZAH's clinical application.
Ardelyx (NASDAQ: ARDX) ha annunciato che un'analisi post-hoc del loro OPTIMIZE Study per XPHOZAH® (tenapanor) sarà presentata ai National Kidney Foundation Spring Clinical Meetings nell'aprile 2025. Lo studio ha coinvolto 330 pazienti con malattia renale cronica in dialisi con iperfosfatemia.
XPHOZAH, il primo e unico inibitore dell'assorbimento di fosfati (PAI), è approvato dalla FDA per ridurre il fosforo sierico nei pazienti adulti con CKD in dialisi come terapia aggiuntiva. È specificamente indicato per i pazienti con risposta inadeguata ai leganti del fosfato o per quelli intolleranti alla terapia con leganti. Il farmaco è somministrato come una singola compressa due volte al giorno.
La presentazione del poster si concentrerà su come i pazienti trattati con tenapanor che utilizzano agenti antidiarroici da banco abbiano sperimentato una diminuzione della frequenza delle feci e un miglioramento della consistenza delle feci. Inoltre, Ardelyx sponsorizzerà un Exhibitor Showcase che discuterà le strategie di gestione dell'iperfosfatemia e l'applicazione clinica di XPHOZAH.
Ardelyx (NASDAQ: ARDX) anunció que un análisis post-hoc de su OPTIMIZE Study para XPHOZAH® (tenapanor) se presentará en las Reuniones Clínicas de Primavera de la Fundación Nacional del Riñón en abril de 2025. El estudio involucró a 330 pacientes con enfermedad renal crónica en diálisis con hiperfosfatemia.
XPHOZAH, el primer y único inhibidor de la absorción de fosfatos (PAI), está aprobado por la FDA para reducir el fósforo sérico en pacientes adultos con ERC en diálisis como terapia complementaria. Está específicamente indicado para pacientes con respuesta inadecuada a los quelantes de fosfato o aquellos intolerantes a la terapia con quelantes. El medicamento se administra como una sola tableta dos veces al día.
La presentación del póster se centrará en cómo los pacientes tratados con tenapanor que utilizan agentes antidiarreicos de venta libre experimentaron una disminución en la frecuencia de las heces y una mejora en la consistencia de las heces. Además, Ardelyx patrocinará un Exhibitor Showcase que discutirá las estrategias de manejo de la hiperfosfatemia y la aplicación clínica de XPHOZAH.
Ardelyx (NASDAQ: ARDX)는 XPHOZAH® (테나파노르)에 대한 OPTIMIZE Study의 후속 분석 결과가 2025년 4월에 열리는 전국신장재단 봄 임상 회의에서 발표될 것이라고 발표했습니다. 이 연구는 고인산혈증을 앓고 있는 투석 환자 330명을 대상으로 진행되었습니다.
XPHOZAH는 첫 번째이자 유일한 인산 흡수 억제제(PAI)로, FDA 승인을 받아 투석 중인 성인 만성 신장 질환(CKD) 환자에게 혈청 인산을 줄이기 위한 추가 치료제로 사용됩니다. 이는 인산 결합제에 대한 반응이 불충분하거나 결합제 치료에 내성이 있는 환자에게 특히 적합합니다. 이 약물은 하루 두 번 단일 정제로 투여됩니다.
포스터 발표는 테나파노르로 치료받은 환자들이 일반 의약품 항설사제를 사용했을 때 대변 빈도가 감소하고 대변의 일관성이 개선된 방법에 초점을 맞출 것입니다. 또한 Ardelyx는 고인산혈증 관리 전략과 XPHOZAH의 임상 적용에 대해 논의하는 전시업체 쇼케이스를 후원할 것입니다.
Ardelyx (NASDAQ: ARDX) a annoncé qu'une analyse post-hoc de leur OPTIMIZE Study pour XPHOZAH® (ténafanor) sera présentée lors des Réunions Cliniques de Printemps de la National Kidney Foundation en avril 2025. L'étude a impliqué 330 patients atteints de maladie rénale chronique sous dialyse avec hyperphosphatémie.
XPHOZAH, le premier et unique inhibiteur de l'absorption des phosphates (PAI), est approuvé par la FDA pour réduire le phosphore sérique chez les patients adultes atteints de MRC sous dialyse en tant que thérapie complémentaire. Il est spécifiquement indiqué pour les patients ayant une réponse inadéquate aux liants de phosphate ou ceux intolérants à la thérapie par liants. Le médicament est administré sous forme de comprimé unique deux fois par jour.
La présentation du poster se concentrera sur la manière dont les patients traités avec le ténafanor utilisant des agents antidiarrhéiques en vente libre ont connu une diminution de la fréquence des selles et une amélioration de la consistance des selles. De plus, Ardelyx parrainera un Exposant Showcase discutant des stratégies de gestion de l'hyperphosphatémie et de l'application clinique de XPHOZAH.
Ardelyx (NASDAQ: ARDX) gab bekannt, dass eine post-hoc Analyse ihrer OPTIMIZE-Studie zu XPHOZAH® (Tenapanor) auf den National Kidney Foundation Spring Clinical Meetings im April 2025 präsentiert wird. Die Studie umfasste 330 Patienten mit chronischer Nierenerkrankung, die aufgrund von Hyperphosphatämie dialysiert wurden.
XPHOZAH, der erste und einzige Inhibitor der Phosphatabsorption (PAI), ist von der FDA genehmigt, um den Serumphosphorspiegel bei erwachsenen CKD-Patienten in der Dialyse als Zusatztherapie zu senken. Es ist speziell für Patienten angezeigt, die unzureichend auf Phosphatbinder reagieren oder intolerant gegenüber Bindertherapien sind. Das Medikament wird als eine Tablette zweimal täglich verabreicht.
Die Posterpräsentation wird sich darauf konzentrieren, wie Patienten, die mit Tenapanor behandelt wurden und rezeptfreie Antidiarrhoika verwendeten, eine verringerte Stuhlfrequenz und eine verbesserte Stuhlkonsistenz erlebten. Darüber hinaus wird Ardelyx eine Ausstellerpräsentation sponsern, die Strategien zur Behandlung von Hyperphosphatämie und die klinische Anwendung von XPHOZAH diskutiert.
- FDA-approved first-in-class phosphate absorption inhibitor
- Simplified dosing regimen (single tablet twice daily)
- Demonstrated efficacy in managing phosphorus levels in CKD patients
- Shows potential benefits in stool-related side effects when combined with antidiarrheal agents
- Requires add-on antidiarrheal agents to manage side effects
- to use as add-on therapy rather than first-line treatment
WALTHAM, Mass., March 31, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today 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.
XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily.
OPTIMIZE was a randomized, open label study, which included 330 patients with chronic kidney disease (CKD) on dialysis with hyperphosphatemia. The study was designed to evaluate different methods of initiating XPHOZAH to optimize phosphorus management in both binder-naïve and binder-treated patients.
Title: Tenapanor-Treated Patients Using Over-the-Counter Antidiarrheal Agents Saw Decreased Stool Frequency and Improved Stool Consistency
Authors: Steven Fishbane, Suling Zhao, Susan Edelstein, Yang Yang, David Spiegel
Poster Number: G-310
Date/Time: April 10, 2025, from 5:15 to 7:30 PM EDT
Information regarding NKF Spring Clinical Meetings, including the presentation abstract, can be found here.
In addition to the poster presentation during NKF Spring Clinical Meetings, Ardelyx is sponsoring an Exhibitor Showcase titled: “A Different Perspective on Hyperphosphatemia Management: Evaluating Current Strategies” on April 11, 2025, from 12:00-12:35 PM EDT, where Dr. Vincent Carsillo, will discuss first-in-class PAI, XPHOZAH. The presentation will review the XPHOZAH mechanism of action, efficacy and safety data from the Phase 3 clinical trial program and will include a discussion about the clinical application of XPHOZAH as add-on therapy for the many dialysis patients on a phosphate binder with serum phosphorus levels above guideline-established targets.
About XPHOZAH® (tenapanor)
XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Please see additional full Prescribing Information.
About Hyperphosphatemia
Hyperphosphatemia is a serious condition, defined as elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis, with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XPHOZAH is contraindicated in:
- Pediatric patients under 6 years of age
- Patients with known or suspected mechanical gastrointestinal obstruction
WARNINGS AND PRECAUTIONS
Diarrhea
Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.
MOST COMMON ADVERSE REACTIONS
Diarrhea, which occurred in 43
INDICATION
XPHOZAH (tenapanor), 30 mg BID, is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
For additional safety information, please see full Prescribing Information.
About Ardelyx
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook.
Investor and Media Contacts:
Lindsey Manuel
lmanuel@ardelyx.com
FAQ
What were the key findings of the ARDX OPTIMIZE Study for XPHOZAH?
What is the FDA-approved indication for XPHOZAH (tenapanor)?
How is XPHOZAH administered to patients with CKD?
When will Ardelyx present the XPHOZAH OPTIMIZE Study results?
