This pilot study is proposing a novel approach to directly target intestinal oxalate absorption with the drug Tenapanor, which was recently FDA-approved for treating hyperphosphatemia in patients with chronic kidney disease. Tenapanor works by blocking paracellular phosphate absorption by the intestine, but the underlying mechanisms have not been clearly defined. Since phosphate and oxalate ions are absorbed through the same paracellular pathway, and are of similar size and charge, Tenapanor is hypothesized to also reduce dietary oxalate absorption and consequently lower urinary oxalate excretion.

Start Date01 Jul 2024

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

[+1]

NCT05995899 / RecruitingPhase 4IIT

An Open-label, Single Center Investigator Sponsored Study Assessing the Effect of Tenapanor on Metagenomic and Metabolomic Markers in Patients With Irritable Bowel Syndrome With Constipation

The aim of this study is to better understand how tenapanor affects the metagenomics and metabolomics of patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor is the newest FDA-approved agent for IBS-C. It is a small molecule that inhibits the NHE3 receptor, leading to impaired sodium and water absorption in the intestine. Previous clinical trials comparing tenapanor to placebo showed that a 50 mg dose of tenapanor led to increased bowel movements and decreased abdominal pain. This study consists of an 8-week treatment period in which subjects will ingest one capsule of tenapanor (50 mg per dose), twice daily, and send in stool samples following 4 weeks and 8 weeks of treatment.

Start Date06 Feb 2024

Sponsor / Collaborator

The Schwartz Center for Compassionate Healthcare

[+1]

100 Clinical Results associated with Tenapanor Hydrochloride

100 Translational Medicine associated with Tenapanor Hydrochloride

100 Patents (Medical) associated with Tenapanor Hydrochloride

Literatures (Medical) associated with Tenapanor Hydrochloride

01 Feb 2024·Clinical and experimental nephrology

Tenapanor for peritoneal dialysis patients with hyperphosphatemia: a phase 3 trial

Article

Author: Akizawa, Tadao ; Fukagawa, Masafumi ; Nakanishi, Kaoru ; Nakayama, Masaaki ; Kusakabe, Miho ; Kobayashi, Shuhei ; Ohara, Meiko

Abstract:

Background:

Tenapanor is a novel selective inhibitor of intestinal sodium/hydrogen exchanger 3 transporter. This is the first trial to assess the efficacy and safety of tenapanor in Japanese patients with hyperphosphatemia who are undergoing peritoneal dialysis.

Methods:

This phase 3, open-label, multicenter, single-arm clinical trial targeted patients whose serum phosphorus was within 3.5–7.0 mg/dL with phosphate binders at screening. After phosphate binder washout, tenapanor was orally administered twice-daily, stepwise from 5 to 30 mg/dose for 16 weeks. The primary endpoint, mean change in serum phosphorus level, was evaluated at week 8. The 16-week treatment period was completed with tenapanor alone, and only one phosphate binder type was allowed for combined use after the primary endpoint.

Results:

Of the 54 patients enrolled, 34 completed the study. At week 8, the primary endpoint, mean change in serum phosphorus level (last observation carried forward), was − 1.18 mg/dL (95% confidence interval: − 1.54, − 0.81 mg/dL) with tenapanor. From a baseline value of 7.65 mg/dL, serum phosphorus decreased to 6.14 and 5.44 mg/dL at weeks 8 and 16, respectively, and 46.3% and 76.5% of patients achieved serum phosphorus within 3.5–6.0 mg/dL at week 8 and week 16, respectively. The most common adverse event, diarrhea, occurred in 74.1% of patients; the severity of diarrhea was mild or moderate. Thus, the discontinuation percentage due to diarrhea was low at 5.6%.

Conclusions:

Administration of tenapanor resulted in a sufficient reduction in serum phosphorus level at week 8 and was considered safe and tolerable.

Trial registration:

NCT04766385.

01 Feb 2024·American journal of physiology. Cell physiology

Enhancement of intestinal calcium transport by short-chain fatty acids: roles of Na⁺/H⁺ exchanger 3 and transient receptor potential vanilloid subfamily 6

Article

Author: Wongdee, Kannikar ; Charoensetakul, Netnapa ; Thammayon, Nithipak ; Charoenphandhu, Narattaphol ; Suntornsaratoon, Panan ; Chanpaisaeng, Krittikan ; Teerapornpuntakit, Jarinthorn ; Panmanee, Jiraporn ; Srimongkolpithak, Nitipol

Organic molecules in the intestinal lumen, e.g., glucose and short-chain fatty acids (SCFAs), the latter of which are normally produced by microfloral fermentation, can stimulate calcium absorption dependent on transient receptor potential vanilloid subfamily 6 (TRPV6) and Na+/H+ exchanger 3 (NHE3). A selective TRPV6 inhibitor synthesized and demonstrated by in silico docking and molecular dynamics to specifically bind to the pore domain of TRPV6 was used to confirm a significant contribution of this channel. Our findings corroborate physiological significance of nutrients and SCFAs in enhancing calcium absorption.

04 Jan 2024·Clinical kidney journal

Tenapanor in Chinese ESRD patients with hyperphosphatemia on haemodialysis: a randomised, phase 3 trial

Article

Author: Zuo, Li ; Zhong, Wen ; Gao, Ju ; Zhou, Linghui ; Luo, Ping ; Sun, Fuyun ; Zhou, Yongchun ; Wei, Gang ; Jiang, Hong ; Sun, Xiuli ; Guan, Tianjun ; Gan, Liangying ; Xing, Li ; Xu, Yan ; Guo, Minghao ; Wang, Junxia ; Guo, Zhiyong

ABSTRACT:

Background:

The efficacy and safety of tenapanor has not been confirmed in Chinese end-stage renal disease (ESRD) patients with hyperphosphatemia on haemodialysis (HD).

Methods:

This was a randomised, double blind, phase 3 trial conducted at 26 dialysis facilities in China (https://www.chictr.org.cn/index.aspx; CTR20202588). After a 3-week washout, adults with ESRD on HD with hyperphosphatemia were randomised (1:1) using an interactive web response system to oral tenapanor 30 mg twice a day or placebo for 4 weeks. The primary endpoint was the change in mean serum phosphorous level from baseline to the endpoint visit (day 29 or last serum phosphorus measurement). Efficacy was analysed in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of the study drug.

Results:

Between 5 March 2021 and 8 June 2022, 77 patients received tenapanor and 73 received placebo. Tenapanor treatment (n = 75) resulted in a significantly greater least squares (LS) mean reduction in serum phosphate at the endpoint visit versus placebo (n = 72): LS mean difference −1.17 mg/dl (95% CI −1.694 to −0.654, P < .001). More patients receiving tenapanor achieved a serum phosphorous level <5.5 mg/dl at the endpoint visit (44.6% versus 10.1%). The most common treatment-related adverse event was diarrhoea [tenapanor 28.6% (22/77), placebo 2.7% (2/73)], which was mostly mild and led to treatment discontinuation in two patients receiving tenapanor.

Conclusions:

Tenapanor significantly reduced the serum phosphorous level versus placebo in Chinese ESRD patients on HD and was generally well tolerated.

130

News (Medical) associated with Tenapanor Hydrochloride

18 Jul 2024

·firstwordpharma.com

Ardelyx takes CMS to court over ending Medicare Part D coverage for Xphozah

Ardelyx has filed a lawsuit against the US Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) over their decision to include Xphozah (tenapanor) and other oral-only phosphate-lowering therapies (PLTs) in the bundled payment system for dialysis recipients. Starting January 1 next year, CMS plans on moving Xphozah and other PLTs to the End-Stage Renal Disease Prospective Payment System (ESRD PPS), thereby ending their coverage under Medicare Part D. However, Ardelyx claims these drugs are not administered at dialysis centres and cannot be taken during maintenance dialysis sessions, making it crucial for patients to obtain them through outpatient pharmacy benefit plans. Earlier this month, the drugmaker decided against filing for Transitional Drug Add-on Payment Adjustment (TDAPA) to preserve patient access to its medication.The suit – also backed by the advocacy groups American Association of Kidney Patients (AAKP) and National Minority Quality Forum (NMQF) – contests that the CMS’ decision is likely to “significantly and negatively impact patient choice of and timely access to important medications.” The planned move will also disincentivise “development of new…medicines that can…address unmet needs in an already underserved therapeutic area,” said Mike Raab, chief executive of Ardelyx. The company has remained a strong supporter of bipartisan legislation, dubbed the Kidney PATIENT Act, introduced to the US Senate to delay the inclusion of oral PLTs in the ESRD PPS. Jefferies analysts said the “uncertainty around Congress' ability to delay oral phosphate binders from moving into the dialysis bundle” was likely to hurt investors’ sentiment on Xphozah, adding that an expert predicted a 65% to 75% chance of Congress passing the legislation by the year-end.Ardelyx, which inhibits phosphate absorption through its primary pathway, was cleared in the US last year after a previous regulatory hurdle, as an add-on therapy to lower serum phosphorus in patients on dialysis who are refractory or intolerant to phosphate-binder therapies alone. Such patients now risk losing access to an “FDA-approved therapy that is providing them a meaningful clinical benefit,” Raab added. In a FirstWord poll of US nephrologists conducted last year, over 60% of respondents said they would consider switching patients to Ardelyx from another drug for hyperphosphataemia.

Patent Infringement

17 Jul 2024

·www.globenewswire.com

Ardelyx, AAKP and NMQF File Lawsuit to Protect Dialysis Patient Choice and Timely Access to Clinically Meaningful Medicines

Lawsuit challenges CMS’s statutory overreach in its determination to include oral-only phosphate-lowering therapies in the End-Stage Renal Disease Prospective Payment System Inclusion of oral-only phosphate lowering therapies within the ESRD PPS limits patient choice and timely access to important innovations and treatment options for unmet needs WALTHAM, Mass., July 17, 2024 (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, in partnership with the American Association of Kidney Patients (AAKP), the nation’s largest independent kidney patient organization, and the National Minority Quality Forum (NMQF), the nation's largest minority healthcare research, education and advocacy organization, it has filed a lawsuit against the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS), claiming that CMS’s plan to include XPHOZAH® (tenapanor), along with all other oral-only phosphate lowering therapies (PLTs), in the End-Stage Renal Disease Prospective Payment System (ESRD PPS) will significantly and negatively impact patient choice of and timely access to important medications. The lawsuit claims that CMS has violated its statutory and regulatory authority under the Medicare Improvements for Patients and Providers Act (MIPPA), which established the ESRD PPS bundled payment system for dialysis services in 2008. Specifically, the lawsuit claims that CMS’s plan to move XPHOZAH, along with all oral-only PLTs, into the ESRD PPS is inconsistent with MIPPA’s statutory provision, and contradicts CMS’s own regulations. XPHOZAH and other PLTs, which are currently available to patients under outpatient pharmacy benefit plans such as Medicare Part D, are not administered by dialysis providers and cannot be taken during the delivery of maintenance dialysis. The plaintiffs seek relief under the Administrative Procedure Act to enjoin CMS from proceeding with its plan to include XPHOZAH in the ESRD PPS and eliminate coverage under Medicare Part D beginning on January 1, 2025. “It is abundantly clear that moving XPHOZAH and other PLTs into the ESRD PPS will result in the imposition of severe care choice and timely access restrictions for all dialysis patients. The planned move by CMS will continue to create disincentives for the development of new and important medicines that can improve patient health and address unmet needs in an already underserved therapeautic area,” said Mike Raab, president and chief executive officer of Ardelyx. “In the eight months that our first-in-class phosphate absorption inhibitor, XPHOZAH, has been in clinical use, many patients have now been able to achieve and maintain phosphorus levels within the target range. Patients with elevated phosphorus have few options to improve their condition and are now at risk of losing choice and timely access to a brand new, FDA-approved therapy that is providing them a meaningful clinical benefit. This lawsuit attempts to stop CMS’s continued harmful statutory overreach and better protect dialysis patients’ choice and timely access to important new therapies.” XPHOZAH was approved by the U.S. Food and Drug Administration in October 2023 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. Eighty percent of patients with CKD on dialysis require prescription therapy to lower elevated levels of serum phosphorus. Phosphate binders are not sufficient for a majority of patients to achieve and maintain phosphorus levels within target range. 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. 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 HyperphosphatemiaHyperphosphatemia 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 (XPHOZAH) CONTRAINDICATIONS XPHOZAH is contraindicated in: Pediatric patients under 6 years of agePatients with known or suspected mechanical gastrointestinal obstruction WARNINGS AND PRECAUTIONSDiarrhea 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 43-53% 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. 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. 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 ArdelyxArdelyx 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 submitted 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. About the American Association of Kidney Patients (AAKP) Since 1969, AAKP has been a patient-led organization driving policy discussions on kidney patient care choice and medical innovations to improve patient lives and prevent avoidable illness and death. AAKP advocates played a central role in the Congressional authorization of the modern ESRD program and coverage for dialysis and transplantation. Over the past decade, AAKP patient advocates have helped advance lifetime transplant drug coverage for kidney transplant recipients (2020); the presidential Executive Order on Advancing American Kidney Health (2019); new job protections for living organ donors under the Family Medical Leave Act (FMLA) via the U.S. Department of Labor (2018); and Congressional legislation allowing HIV-positive organ transplants for HIV-positive patients (2013). Follow AAKP on social media at @kidneypatient on Facebook, @kidneypatients on Twitter, and @kidneypatients on Instagram, and visit http://www.aakp.org for more information. About National Minority Quality ForumThe National Minority Quality Forum (NMQF) is a 501(c)(3) not-for-profit research and advocacy organization based in Washington, DC. The mission of NMQF is to reduce patient risk by assuring optimal care for all. NMQF’s vision is an American health services research, delivery and financing system whose operating principle is to reduce patient risk for amenable morbidity and mortality while improving quality of life. For more information, please visit www.nmqf.org. Forward Looking Statements 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 impact that moving XPHOZAH and PLTs into the ESRD PPS will have on patient access and the clinical benefit of XPHOZAH. 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. and internationally. 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 May 2, 2024, and its future current and periodic reports to be filed with the Securities and Exchange Commission. Investor and Media Contacts: Caitlin Lowieclowie@ardelyx.com

Drug Approval

02 Jul 2024

·www.globenewswire.com

To Preserve Patient Access to XPHOZAH®, Ardelyx Chooses Not to File for TDAPA

Ardelyx continues support for bipartisan legislation that would extend the exclusion of oral-only medications from entering the CMS Prospective Payment System Conference call scheduled for 8:00 AM Eastern Time WALTHAM, Mass., July 02, 2024 (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, 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). Ardelyx’s analysis of the CMS policy to include oral-only medicines in the PPS and the Calendar Year 2025 ESRD PPS Proposed Rule released on June 27, 2024, revealed that the policy and the manner in which CMS intends to implement it are likely to cause significant restrictions on the use of XPHOZAH for all patients, irrespective of insurance coverage, because it interferes with the essential and appropriate shared decision-making between healthcare professionals and their patients. “At Ardelyx, we recognize that the only way innovative medicines like XPHOZAH can deliver their proven benefits to patients is by ensuring that those prescribed our medicines have access to them. XPHOZAH is the only therapy approved for patients who have an inadequate response to phosphate binder therapy and during the eight months it has been utilized in clinical practice, it is clear that patients are benefitting from and need continued access to this therapeutic option to reduce elevated serum phosphorus,” said Mike Raab, president and CEO of Ardelyx. “We have carefully and thoughtfully considered the potential impact of CMS’s decision to add XPHOZAH into the Medicare PPS and have determined that even during the TDAPA period, the restrictions placed on XPHOZAH would be such that patient access to this novel therapy would be effectively eliminated for all patients. We believe that the proposed bipartisan legislation extending the exclusion of oral-only medications from the Medicare ESRD PPS is the best option to ensure continued patient access, and we call on Congress to pass the bill. Our decision not to apply for TDAPA reflects our steadfast commitment to preserving patients’ access to our medicines and provides the best optionality for us to continue to explore alternatives to protect all patients.” XPHOZAH was approved by the U.S. Food and Drug Administration in October 2023 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. Eighty percent of patients with CKD on dialysis require prescription therapy to lower elevated levels of serum phosphorus. Phosphate binders are not sufficient for a majority of patients to achieve and maintain phosphorus levels within target range. 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. Conference Call DetailsThe company will host a conference call today, July 2, 2024, at 8:00 am ET to discuss today's announcement. To participate in the conference call, please dial (844) 481-2838 (domestic) or (412) 317-1858 (international) and ask to be joined into the Ardelyx call. A webcast of the call can also be accessed by visiting the Investor page of the company's website, https://ardelyx.com/, and will be available on the website for 30 days following the call. 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 HyperphosphatemiaHyperphosphatemia is a serious condition, defined as resulting in 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 (XPHOZAH) CONTRAINDICATIONS XPHOZAH is contraindicated in: Pediatric patients under 6 years of agePatients with known or suspected mechanical gastrointestinal obstruction WARNINGS AND PRECAUTIONSDiarrhea 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 43-53% 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. 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. 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 ArdelyxArdelyx 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 submitted 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. Forward Looking StatementsTo 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 impact of the TDAPA period and the ESRD PPS policy on access to XPHOZAH and our current belief that not applying for TDAPA provides the best optionality to explore options to provide access to all patients. 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. and internationally. 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 May 2, 2024, and its future current and periodic reports to be filed with the Securities and Exchange Commission. Investor and Media Contacts: Caitlin Lowieclowie@ardelyx.com

Drug Approval

100 Deals associated with Tenapanor Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11653	Tenapanor Hydrochloride	A06AX	DB11761

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hyperphosphatemia	JP	Kyowa Kirin Co., Ltd.	25 Sep 2023
Irritable bowel syndrome with constipation	US	Ardelyx, Inc.	12 Sep 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Kidney Failure, Chronic	Phase 3	US	Ardelyx, Inc.	01 Jan 2016
Irritable Bowel Syndrome	Phase 3	US	Ardelyx, Inc.	01 Oct 2015
Parkinson Disease	Phase 2	-	Ardelyx, Inc.	01 Dec 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04549597 (OPTIMIZE, Pubmed)	Phase 4	Hyperphosphatemia Maintenance intact fibroblast growth factor 23 (iFGF23) \| parathyroid hormone (PTH) \| serum calcium	333	Tenapanor alone	usypcnjhdg(gcqkokcimf) = 133 of 333 [39.9%] tuaheffucw (wgqpdhsobg )	Positive	07 Feb 2024
				Tenapanor in combination with phosphate binders
NCT02675998 \| NCT03427125 \| NCT03824587 (TEN-02-202 , FDA) Manual	Phase 2/3	Hyperphosphatemia	964	XPHOZAH (TEN-02-301)	bllvwwvyly(njfrodftrp) = xllmxqlfnu naklyazbvz (pbezkrmetg, 0.2 - 1.1)	Positive	17 Oct 2023
				placebo (TEN-02-301)	-
NCT03427125 (PHREEDOM \| TEN-02-301, CTgov)	Phase 3	Hyperphosphatemia \| Kidney Failure, Chronic	1,559	Tenapanor (Tenapanor 10 mg, 20 mg, 30 mg BID)	futvpypxzp(sgjwgymuxz) = lxfhsrhqpv jfzegbxuix (bclmbiunjv, vxwincspsm - lzemqwauuu) View more	-	29 Jun 2023
				Placebo (Placebo)	futvpypxzp(sgjwgymuxz) = brkhynfyqh jfzegbxuix (bclmbiunjv, nwtukqjlbp - akdnwvemet) View more
NCT04549597 (OPTIMIZE, CTgov)	Phase 4	Hyperphosphatemia \| Chronic Kidney Diseases	333	Tenapanor (Cohort 1: Straight Switch)	rmsipppfxw(xodtscccxt) = pgfiukwyyv vwkqnjghoz (qnzhuelxws, bqvljceyix - dropslvfzp) View more	-	29 Mar 2023
				Tenapanor (Cohort 2: Decrease Phosphate Binder by 50%)	rmsipppfxw(xodtscccxt) = qfapirhtpr vwkqnjghoz (qnzhuelxws, skxnepiqss - tvdcdnucja) View more
NCT03988920 (CTgov)	Phase 4	Hyperphosphatemia \| Kidney Failure, Chronic	172	Sevelamer Carbonate+Tenapanor (Tenapanor w/Sevelamer)	aaljzoyuoh(okubbcxybj) = lxrundhzwf dxsmgomyhg (ymdhgqhata, heeuvprpkz - jtcmfoslwl) View more	-	29 Mar 2023
				Sevelamer Carbonate+Tenapanor (Sevelamer w/Tenapanor)	aaljzoyuoh(okubbcxybj) = ibrwzkgmmw dxsmgomyhg (ymdhgqhata, ftgyitwznz - vinfubtdxo) View more
NCT03824587 (AMPLIFY \| TEN-02-202 , CTgov)	Phase 2/3	Hyperphosphatemia \| Kidney Failure, Chronic	236	Tenapanor+Phosphate Binder Agents (Tenapanor 30 mg BID)	ompgdvtlmy(zrmeujyioj) = ngolccoqri vqdslpjtdk (znrvwppbrh, lyeuhpdknt - sgtgzlrgsy) View more	-	06 Mar 2023
				Placebo+Phosphate Binder Agents (Placebo)	ompgdvtlmy(zrmeujyioj) = fzugnocexy vqdslpjtdk (znrvwppbrh, icelrakbdo - pstbnhowrw) View more
NCT03824587 (AMPLIFY, ASN2022)	Phase 3	Chronic Kidney Diseases	-	Tenapanor 30 mg	rexjfpveto(exzyplcbsh) = pnubjlttkn rocwosezwv (xulapqamhf, 23.0)	Positive	05 Nov 2022
				Placebo	rexjfpveto(exzyplcbsh) = ysbgqxpznu rocwosezwv (xulapqamhf, 26.6) View more
NCT03427125 (PHREEDOM, ASN2022) Manual	Phase 3	Hyperphosphatemia \| Chronic Kidney Diseases	204	Tenapanor (patients with baseline sP ≥7.5 mg/dL)	avwpyiykgu(vehvmisfad) = qcwjvumjek kmgghamxhn (dcdytmlcsc, 1.86) View more	Positive	03 Nov 2022
NCT04766398 (ASN2022) Manual	Phase 3	Hyperphosphatemia	169	phosphate binders+Tenapanor	sbdjfsudhr(znefcwkdbi) = ffpftsghmo eptejovwky (rmzaxuhvak ) View more	Positive	03 Nov 2022
				phosphate binders+Placebo	sbdjfsudhr(znefcwkdbi) = phapeqqcmu eptejovwky (rmzaxuhvak ) View more
NCT04767581 (ASN2022) Manual	Phase 3	Hyperphosphatemia	164	Tenapanor	mbhbemaynv(imqmpixvux) = wrkxxrtbzf tlznvglmxb (azupkmazcw ) View more	Positive	03 Nov 2022
				Placebo	mbhbemaynv(imqmpixvux) = vpasscoqsb tlznvglmxb (azupkmazcw ) View more

Translational Medicine

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