XPHOZAH is the first and only FDA approved phosphate absorption inhibitor

XPHOZAH是第一个也是唯一一个FDA批准的磷酸盐吸收抑制剂

Best-in-class patient services programs support patient access and affordability for XPHOZAH patients

一流的患者服务计划支持XPHOZAH患者的患者访问和负担能力

WALTHAM, Mass., Nov. 06, 2023 (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 XPHOZAH is now available for shipment to partner pharmacies.

马萨诸塞州沃尔瑟姆，2023年11月6日（GLOBE NEWSWIRE）-Ardelyx，Inc。（纳斯达克股票代码：ARDX），一家生物制药公司，旨在发现，开发和商业化创新的一流药物满足今天宣布，XPHOZAH现已可用于运送至合作伙伴药房。

XPHOZAH® (tenapanor) 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. XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway..

XPHOZAH®（tenapanor）用于降低慢性肾病（CKD）成人透析时的血清磷，作为对磷酸盐结合剂反应不足或不能耐受任何剂量磷酸盐结合剂治疗的患者的附加治疗。XPHOZAH是一种单片，每天服用两次，提供一流的作用机制，可通过其主要途径阻止磷酸盐吸收。。

“The kidney community has been waiting a long time for another option to help manage hyperphosphatemia and we are proud to announce that XPHOZAH is now being shipped to our partner pharmacies,” said Mike Raab, president and chief executive officer of Ardelyx. “We look forward to engaging with healthcare providers and supporting patient access and affordability for this new therapeutic option with a differentiated mechanism of action.”.

Ardelyx总裁兼首席执行官Mike Raab说：“肾脏界一直在等待另一种方法来帮助管理高磷血症，我们很自豪地宣布XPHOZAH现在正在运送到我们的合作伙伴药房。”。“我们期待与医疗保健提供者进行接触，并以不同的行动机制支持患者获得和负担这种新的治疗方案。”。

Ardelyx is committed to setting new standards in product innovation and to setting new standards for patient support. Ardelyx will integrate XPHOZAH into its established patient services program, ArdelyxAssist™. ArdelyxAssist is an innovative, digital-forward patient services program that provides access and affordability support for patients, with integration into medical office work processes and connectivity to patients and health care providers..

Ardelyx致力于为产品创新制定新标准，并为患者支持制定新标准。Ardelyx将把XPHOZAH整合到其已建立的病人服务项目ArdelyxAssist中™. ArdelyxAssist是一项创新的数字前向患者服务计划，为患者提供访问和负担能力支持，并融入医疗办公室工作流程以及与患者和医疗保健提供者的连接。。

About XPHOZAH® (tenapanor)

关于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.

由Ardelyx发现和开发的XPHOZAH是一流的磷酸盐吸收抑制剂，具有不同的作用机制，可在肠道局部起作用，抑制钠氢交换剂3（NHE3），从而减少通过细胞旁途径的磷酸盐吸收，磷酸盐吸收的主要途径。

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..

XPHOZAH是一片，每天服用两次。腹泻是临床试验中服用XPHOZAH的患者最常见的副作用。请参阅其他完整的处方信息。。

About Hyperphosphatemia

关于高磷血症

Hyperphosphatemia is a serious condition, defined 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.

高磷血症是一种严重的疾病，定义为血液中磷酸盐水平升高，这影响了美国55万患有慢性肾病（CKD）的维持性透析患者中的绝大多数。肾脏负责消除过量的磷酸盐，并且随着肾功能下降，磷酸盐不能从体内充分消除。

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)..

因此，高磷血症在维持性透析CKD患者中几乎是普遍存在的疾病，国际公认的KDIGO治疗指南建议将磷酸盐水平升高至正常范围（2.5-4.5mg/dL）。。

IMPORTANT SAFETY INFORMATION

重要的安全信息

CONTRAINDICATIONS

禁忌症

XPHOZAH is contraindicated in:

XPHOZAH禁忌用于：

Pediatric patients under 6 years of age

6岁以下的儿科患者

Patients with known or suspected mechanical gastrointestinal obstruction

已知或疑似机械性胃肠道阻塞的患者

WARNINGS AND PRECAUTIONS

警告和注意事项

Diarrhea

腹泻

Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.

患者可能会出现严重腹泻。发生严重腹泻的患者应停止使用XPHOZAH治疗。

MOST COMMON ADVERSE REACTIONS

最常见的不良反应

Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction.

在43-53%的患者中发生腹泻，是至少5%的XPHOZAH治疗的CKD患者在透析期间报告的唯一不良反应。据报道，XPHOZAH治疗患者的大多数腹泻事件的严重程度为轻度至中度，并随着时间的推移或剂量减少而消退。

Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials..

通常在开始后不久就报告腹泻，但在用XPHOZAH治疗期间随时可能发生腹泻。在这些试验中，5%的XPHOZAH治疗患者报告严重腹泻。。

INDICATION

指示

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.

XPHOZAH（tenapanor），30 mg BID，用于减少透析时慢性肾病（CKD）成人的血清磷，作为对磷酸盐结合剂反应不足或不能耐受任何剂量磷酸盐的患者的附加疗法粘合剂疗法。

For additional safety information, please see full Prescribing Information.

有关其他安全信息，请参阅完整的处方信息。

About Ardelyx, Inc.

关于Ardelyx，Inc。

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) as well as early-stage pipeline candidates.

Ardelyx的成立使命是发现，开发和商业化满足重大未满足医疗需求的创新一流药物。Ardelyx在美国批准了两种商业产品，即IBSRELA®（tenapanor）和XPHOZAH®（tenapanor）以及早期管道候选产品。

Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin has received approval for PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.

Ardelyx在美国境外拥有tenapanor的开发和商业化协议。Kyowa Kirin已获得日本PHOZEVEL®（tenapanor）高磷血症的批准。Fosun Pharma已在中国提交了针对高磷血症的tenapanor新药申请。Knight Therapeutics在加拿大将IBSRELA商业化。

For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook..

欲了解更多信息，请访问https://ardelyx.com/并通过X（以前称为Twitter），LinkedIn和Facebook与我们联系。。

Forward Looking Statements

前瞻性声明

To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including the potential for XPHOZAH to advance the care of patients with chronic kidney disease on dialysis who have elevated levels of serum phosphorus and the potential for ArdelyxAssist to set new standards in patient support.

如果本新闻稿中的陈述不是对有关Ardelyx的历史事实的描述，则它们是前瞻性陈述，反映了根据1995年《私人证券改革法》的安全港所作的当前管理信念和期望，包括XPHOZAH可能促进血清磷水平升高的透析慢性肾病患者的护理，以及ArdelyxAssist为患者支持设定新标准的潜力。

Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the development of, regulatory process for, and commercialization of drugs in the U.S.

这种前瞻性陈述涉及重大风险和不确定性，可能导致Ardelyx未来的成果，业绩或成就与前瞻性陈述所表达或暗示的显着不同。这些风险和不确定性包括与美国药品开发，监管程序和商业化相关的不确定性。

Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023, and its future current and periodic reports to be filed with the Securities and Exchange Commission..

Ardelyx不承担更新或修改任何前瞻性陈述的义务。有关可能导致实际结果与这些前瞻性陈述中表达的结果不同的风险和不确定性的进一步描述，以及与Ardelyx一般业务相关的风险，请参阅Ardelyx于2023年10月31日提交给证券交易委员会的10-Q表格季度报告，及其未来的当前和定期报告将提交给证券交易委员会。。

Investor and Media Contacts:

投资者和媒体联系人：

Caitlin Lowie

凯特琳·洛伊。

clowie@ardelyx.com

clowie@ardelyx.com