Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for cystic fibrosis-related constipation (CFrC) in CF patients. Participants will ingest one 50 mg tablet of tenapanor, twice daily, for a 4-week treatment period. They will also complete three questionnaires, the PAC-SYM, PAC-QoL, and IBS-SSS, and daily diaries to characterize GI symptom burden and spontaneous bowel movement (SBM) frequency.

Start Date01 Feb 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT06460038

/ RecruitingPhase 2IIT

Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation

Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation

Start Date01 Jan 2025

Sponsor / Collaborator

Ardelyx, Inc.

NCT06553547

/ RecruitingPhase 2

4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety & Efficacy of Tenapanor for the T/t of IBS-C in Pts. 6 to < 12 Yrs. Old

This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.

Start Date24 Jul 2024

Sponsor / Collaborator

Ardelyx, Inc.

100 Clinical Results associated with Tenapanor Hydrochloride

100 Translational Medicine associated with Tenapanor Hydrochloride

100 Patents (Medical) associated with Tenapanor Hydrochloride

126

Literatures (Medical) associated with Tenapanor Hydrochloride

01 Apr 2025·Therapeutic Apheresis and Dialysis

Tenapanor: A novel therapeutic agent for dialysis patients with hyperphosphatemia

Review

Author: Urano, Natsuki ; Ikejiri, Kazuaki ; Fukagawa, Masafumi ; Akizawa, Tadao ; Nakanishi, Kaoru

AbstractPatients on dialysis often develop hyperphosphatemia, contributing to an increased risk of cardiovascular events and mortality. Currently, several types of phosphate binders (PBs) exist for the treatment of hyperphosphatemia, but they are sometimes associated with drug‐specific side effects and high pill burden, making it difficult to control serum phosphorus appropriately. Tenapanor, which has a novel mechanism to reduce serum phosphorus via selective sodium/proton exchange transporter 3 inhibition, was approved for hyperphosphatemia in Japan in 2023. Four phase 3 studies of tenapanor have been performed in Japan and have demonstrated its efficacy and safety as a single‐agent drug, add‐on effects to PBs for patients with refractory hyperphosphatemia that cannot be improved with PBs alone, and reduction of the pill burden associated with PBs. This review provides an overview of the characteristics and previous clinical studies of tenapanor and describes the clinical benefits of tenapanor over current therapy in patients on dialysis.

02 Jan 2025·Drug Development and Industrial Pharmacy

A randomized pilot study to evaluate the stability, taste, and palatability of a novel liquid formulation of tenapanor

Article

Author: Edelstein, Susan ; Kanji, Nazim ; DiMare, Marcello ; Sawant, Amit ; Matusow, David ; Menakuru, Somasekhar R.

OBJECTIVEThis pilot study aimed to develop a liquid formulation of tenapanor and evaluate taste and palatability with different sweetener and flavor combinations.SIGNIFICANCETenapanor is a first-in-class, minimally absorbed, small molecule inhibitor of intestinal sodium/hydrogen exchanger 3, indicated (as tablets) to treat adults with constipation-predominant irritable bowel syndrome. It is also approved as add-on therapy to reduce serum phosphorus in adults with chronic kidney disease on dialysis who are intolerant of, or unacceptably responsive to, any dose of phosphate binder therapy. Since many patients have difficulty swallowing pills and pediatric studies are underway, a liquid formulation was developed, and taste profiles were evaluated for overall acceptability.METHODSFormulation of liquid tenapanor targeted a concentration of 5 mg/mL, for a dosing range of 1-50 mg twice daily. Improvements in solubility and stability of tenapanor in water were investigated with the use of buffers, cosolvents, and preservatives. Seven liquid formulations with different sweetener/flavor combinations were assessed for taste and palatability by healthy adult participants using the sip-and-spit method in a randomized design.RESULTSAn aqueous solution of tenapanor (5 mg/mL), pH 3.4, with 0.05 % (w/v) benzoic acid, was stable at 2-8 °C for 12 months. The formulation with sucralose and raspberry flavor had the greatest improvement in overall acceptability and taste when compared to the reference solution without sweeteners or flavors.CONCLUSIONSA suitable liquid formulation was identified for progression to patient studies.

01 Jan 2025·Journal of Renal Nutrition

Tenapanor: A Phosphate Absorption Inhibitor for the Management of Hyperphosphatemia in Patients With Kidney Failure

Review

Author: Rosenbaum, David P ; Chertow, Glenn M ; Edelstein, Susan ; Spiegel, David M ; Hill Gallant, Kathleen M ; Sprague, Stuart M ; Kozuka, Kenji

Because of increased risks of cardiovascular disease and death, patients with hyperphosphatemia receiving maintenance dialysis are advised to limit phosphorus consumption and are prescribed phosphate binders in an effort to better control serum phosphate concentrations. Because of large pill size, pill burden, and tolerability issues, phosphate binder adherence is relatively poor. On ingestion, phosphate is absorbed from the intestine via transcellular or paracellular transport. Data show that inhibiting sodium-hydrogen exchanger 3 modulates paracellular phosphate absorption (the predominant pathway in humans). Tenapanor is a first-in-class, minimally absorbed, phosphate absorption inhibitor that selectively inhibits sodium-hydrogen exchanger 3, with a mechanism distinct from, and complementary to, that of phosphate binders. In phase 3 and postregistrational studies, tenapanor conferred statistically significant and clinically meaningful reductions in serum phosphate in patients receiving maintenance dialysis with hyperphosphatemia. Here, we review the available preclinical and clinical data on the effects of tenapanor on controlling intestinal phosphate absorption.

143

News (Medical) associated with Tenapanor Hydrochloride

26 Feb 2025

·www.prnewswire.com

Fosun Pharma Received NMPA Approval for Wan Ti Le (Tenapanor Hydrochloride Tablets)

Bringing New Hope to Chinese Dialysis Patients with Hyperphosphatemia SHANGHAI, Feb. 26, 2025 /PRNewswire/ -- Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma; stock code: 600196.SH, 02196.HK) announced that its holding subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharma Industrial"), has received approval from the National Medical Products Administration ("NMPA") for the New Drug Application ("NDA") for Tenapanor Hydrochloride Tablets (Chinese trade name: Wan Ti Le, the "New Drug"), an innovative phosphate absorption inhibitor with a novel mechanism, with the indication being for the control of serum phosphorus levels in dialysis patients with chronic kidney disease (CKD) who have an inadequate response or are intolerant to phosphorus binders. As the world's first and currently only approved phosphate absorption inhibitor, Tenapanor Hydrochloride Tablets has been officially approved in China, ushering in a new era of multi-mechanism synergistic phosphate control and offering new hope for patients with hyperphosphatemia on hemodialysis in China. "The approval of tenapanor for the treatment of adult dialysis patients with chronic kidney disease in China market brings new hope for dialysis patients with hyperphosphatemia in China," said Xingli Wang, Executive President, CEO of Global R&D Center of Fosun Pharma, "Fosun Pharma is committed to addressing unmet clinical needs by focusing on innovative R&D in core therapeutic areas such as oncology, immunology, and chronic diseases. We look forward to our continued collaboration with Ardelyx as we advance the development and commercialization of more innovative therapies, bringing greater benefits to patients. "The approval of tenapanor for hyperphosphatemia in China marks another important milestone in Ardelyx's commitment to bringing our novel therapies to patients with unmet medical needs globally," said Mike Raab, president and chief executive officer of Ardelyx. "I thank our partners at Fosun Pharma for their continued efforts to support this approval. Fosun Pharma is a leading healthcare company in China with a strong focus and track record of successfully marketing cardiorenal medicines in China and shares our commitment to improving the lives of patients. We look forward to further collaboration as Fosun Pharma brings this treatment to patients." Tenapanor Hydrochloride Tablets is a First-in-class oral intestinal sodium/hydrogen exchanger 3 (NHE3) inhibitor licensed by Fosun Pharma Industrial from Ardelyx, Inc. In October 2023, Tenapanor was approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with 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. Tenapanor is also approved for the treatment of Irritable Bowel syndrome with Constipation in the U.S. and Hong Kong SAR. For many years, the rate of achieving target serum phosphate levels in hemodialysis patients in China has been lower than the international standards[1]. Despite existing pharmacotherapy, a significant proportion of patients fail to meet the target phosphate levels. Data indicate that by the end of 2023, there were more than one million patients on maintenance hemodialysis in China, with an annual growth rate of approximately 10%. Among these patients, 76% have hyperphosphatemia, and the rate of achieving target phosphate levels is only 39%[2] (according to China's hemodialysis quality control standards: serum phosphate 1.13–1.78 mmol/L). If the target range for serum phosphate is set at 0.87–1.45 mmol/L, as stipulated by the Chinese guidelines for the diagnosis and treatment of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD), the achievement rate decreases to 26.7%[3]. Given the current situation where the blood phosphorus levels of dialysis patients are poorly controlled, the National Health Commission of China listed "improving phosphate control rates in hemodialysis patients" as a key quality control improvement target for 2024. Tenapanor is a local inhibitor that targets the NA(+)/H(+) exchanger-3 (NHE3), a reverse transporter expressed on the apical surface of the epithelium in the small intestine and colon. By inhibiting NHE3, the drug tightens intercellular junctions, thereby reducing the permeability of the paracellular pathway to phosphate, which is the primary route for intestinal phosphate absorption. This action leads to a decrease in phosphate absorption and, consequently, a reduction in serum phosphorus levels[4]. Owing to its novel mechanism of action, tenapanor can be used in combination with phosphate binders to further significantly reduce serum phosphate levels and improve the rate of achieving target levels. In a randomized, double-blind, placebo-controlled study[5], 164 hemodialysis patients with hyperphosphatemia were enrolled. After 8 weeks of treatment with tenapanor in combination with phosphate binders, serum phosphate levels decreased by an additional 0.57 mmol/L compared to phosphate binders alone. In another multicenter, randomized, open-label study[6], 303 hemodialysis patients who were not achieving target phosphate levels with phosphate binders were switched to a tenapanor-based regimen (tenapanor 30 mg BID, with phosphate binders added or adjusted if necessary). After 10 weeks of treatment, the rate of achieving target phosphate levels increased by 34.4% to 38.2%. A tenapanor can lower levels of parathyroid hormone (PTH)[7] and fibroblast growth factor 23 (FGF23)[8], thereby aiding in the comprehensive achievement of key therapeutic targets in the management of chronic kidney disease–mineral and bone disorder (CKD-MBD). SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3

13 Jan 2025

·www.globenewswire.com

Ardelyx Provides Update on Increasing Commercial Momentum and 2025 Strategic Priorities

Company achieved significant commercial progress in 2024, finishing with total U.S. net product sales revenue of approximately $319 million (unaudited) Company reaffirms peak U.S. net IBSRELA sales revenue of greater than $1 Billion Company announces peak U.S. net XPHOZAH sales revenue of $750 million Company finishes 2024 with approximately $250 million in cash, cash equivalents and investments (unaudited) WALTHAM, Mass., Jan. 13, 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 provided an update on the company’s progress in 2024 and initial expectations for 2025. “In 2024, Ardelyx delivered another year of sustained growth and exceptional performance. The growing demand for IBSRELA and XPHOZAH, both important, first-in-class medicines, has demonstrated that there is a clear unmet need among patients for differentiated therapeutic options,” said Mike Raab, president and chief executive officer. “It is an incredibly exciting time for our company with tremendous opportunities in front of us. As you saw in the performance during the fourth quarter, the team is delivering on the promise of IBSRELA. This performance reaffirms our expectation that IBSRELA can achieve greater than $1 billion in annual sales at peak. In 2024, XPHOZAH’s performance demonstrated its critical role in the treatment of hyperphosphatemia where there continues to be a high unmet need among patients. It is evident that there is a significant opportunity for XPHOZAH and we expect this product will achieve $750 million in annual sales at peak.” Raab continued, “In 2025, we will be focused on our strategic priorities: Maintaining our growth momentum, building a pipeline and delivering a strong financial performance. We remain steadfast in our commitment to operational excellence and to making decisions in the best interest of patients and our shareholders.” IBSRELA® (tenapanor) records approximately $158 million in net product sales revenue in 2024U.S. net product sales revenue for IBSRELA during the fourth quarter is expected to be approximately $54 million, with full year net product sales revenue totaling approximately $158 million, subject to adjustment in connection with preparation of audited financial statements. IBSRELA performance demonstrated consistent quarter-over-quarter growth throughout the year, accelerating in the fourth quarter following the completion of the company’s field-based sales team expansion. In 2025, the company will focus on continued commercial execution to maintain the strong momentum for IBSRELA. Ardelyx currently expects full-year 2025 U.S. net product sales revenue for IBSRELA to be between $240.0 and $250.0 million. Ardelyx continues to expect IBSRELA to achieve greater than ten percent market share at peak and generate more than $1.0 billion in annual U.S. net product sales revenue before patent term expiration. Strong XPHOZAH® (tenapanor) performance continues, recording approximately $161 million net product sales revenue during 2024XPHOZAH demonstrated an exceptional launch and finished its first full year of commercialization with 2024 U.S. net product sales revenue of approximately $161 million, including approximately $57 million in net product sales during the fourth quarter, subject to adjustment in connection with preparation of audited financial statements. The strong response from the prescribing community to XPHOZAH continued throughout the year, with feedback reflecting positive patient experiences and outcomes. XPHOZAH saw continued, quarter-over-quarter growth across all key indicators. At peak, Ardelyx currently expects XPHOZAH to achieve $750 million in annual U.S. net product sales revenue before patent term expiration. Coverage for oral only therapies, including XPHOZAH, is no longer available under Medicare Part D as of January 1, 2025. Access to XPHOZAH remains through a prescription written by a qualifying healthcare provider sent to Transition Pharmacy, the ArdelyxAssist specialty pharmacy partner. Patients who do not have affordable access will be evaluated for eligibility to receive XPHOZAH through the Ardelyx patient assistance program. Strong Cash PositionAs of December 31, 2024, the company had total cash, cash equivalents and short-term investments of approximately $250 million (unaudited). Ardelyx had approximately 238 million shares outstanding as of December 31, 2024. Company Presentation at 42nd Annual J.P. Morgan Healthcare ConferenceThe company will present and provide a business update at the 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025 at 7:30pm ET / 4:30pm PT. A webcast of the presentation can be accessed by visiting the Investor page of the company's website, www.ardelyx.com, and will be available on the website for at least 30 days following the call. IMPORTANT SAFETY INFORMATION (IBSRELA) WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTSIBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. CONTRAINDICATIONS IBSRELA is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. WARNINGS AND PRECAUTIONSRisk of Serious Dehydration in Pediatric Patients IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Diarrhea Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient. MOST COMMON ADVERSE REACTIONS The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%). INDICATION IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults. Please see full Prescribing Information, including Boxed Warning, for additional risk information. IMPORTANT SAFETY INFORMATION (XPHOZAH) CONTRAINDICATIONSXPHOZAH 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 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). 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 Ardelyx’s currents expectations regarding: opportunities for continued adoption of IBSRELA and XPHOZAH, the annual U.S. net product sales revenue for IBSRELA at peak; the annual U.S. net product sales revenue for XPHOZAH at peak; net product sales revenue for IBSRELA for full year 2024 and the fourth quarter ended December 31, 2024; net product sales revenue for IBSRELA for full year 2025; the potential market share for IBSRELA at peak; net product sales revenue for XPHOZAH for the full year 2024 and the fourth quarter ended December 31, 2024; and its cash position at December 31, 2024. 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 October 31, 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 ApprovalFinancial Statement

31 Dec 2024

·www.echemi.com

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

Drug ApprovalPhase 3Clinical ResultADCImmunotherapy

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	Japan	Kyowa Kirin Co., Ltd.	25 Sep 2023
Irritable bowel syndrome with constipation	United States	Ardelyx, Inc.	12 Sep 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hyperphosphatemia	NDA/BLA	China	Ardelyx, Inc.	12 Jul 2023
Cystic Fibrosis	Phase 3	-	Ardelyx, Inc.	01 Feb 2025
Parkinson Disease	Phase 2	United States	Ardelyx, Inc.	01 Jan 2025
Kidney Failure, Chronic	Discovery	United States	Ardelyx, Inc.	01 Jan 2016
Albuminuria	Discovery	United States	Ardelyx, Inc.	01 May 2013
Albuminuria	Discovery	United States	AstraZeneca PLC	01 May 2013
Diabetes Mellitus, Type 2	Discovery	United States	Ardelyx, Inc.	01 May 2013
Diabetes Mellitus, Type 2	Discovery	United States	AstraZeneca PLC	01 May 2013
Chronic kidney disease, Stage V	Discovery	United States	AstraZeneca PLC	01 Jan 2013
Chronic kidney disease, Stage V	Discovery	United States	Ardelyx, Inc.	01 Jan 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DDW2024	Not Applicable	Irritable bowel syndrome with constipation	-	Tenapanor 50 mg	witntgarro(fkspeoqgpl) = eyddlinjxx bnslbzimdl (djvwdeaalm )	-	21 May 2024
				Placebo	witntgarro(fkspeoqgpl) = rlcvdkucwu bnslbzimdl (djvwdeaalm )
ISN WCN2024	Not Applicable	Kidney Failure, Chronic	944	Tenapanor	urbiyhzzdj(wjuunleyha) = Tenapanor significantly increased the incidence of diarrhea relative to placebo qbizyqavak (ecufvhojva ) View more	Positive	01 Apr 2024
NCT04549597 (OPTIMIZE, Pubmed \| Kidney360) Manual	Phase 4	Hyperphosphatemia Maintenance	333	Tenapanor in combintenapanorh phosphate binders	(uqdbalyvks) = awdaylefds uqzuujqgzp (jqjwzitqef ) View more	Positive	07 Feb 2024
				reduce PB dosage by ≥50% and add tenapanor (Binder Reduction)	(uqdbalyvks) = dnedlhahex uqzuujqgzp (jqjwzitqef ) View more
NCT03988920 (NORMALIZE, Pubmed \| Kidney360)	Phase 3	Hyperphosphatemia Maintenance serum intact fibroblast growth factor-23 \| serum intact parathyroid hormone	172	Tenapanor 30 mg twice daily	syivldoker(iezmzbwxex) = The most commonly reported treatment-emergent adverse event was diarrhea in 38 of 172 patients (22%), which led to tenapanor discontinuation in four patients (2%) scdudipbkm (gsnxapjuuz )	Positive	01 Nov 2023
NCT02675998 \| NCT03427125 \| NCT03824587 (TEN-02-202 , FDA) Manual	Phase 2/3	Hyperphosphatemia	964	XPHOZAH (TEN-02-301)	(gzskbzdaju) = szyzqeqkgg untzkzeako (mdaugjcrtc, 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)	fpbajedfyd(qzxctujyit) = bscjihlfzg xhwdckuail (zjoupxqiwf, ruyytdzuld - zngqmabsma) View more	-	29 Jun 2023
				Placebo (Placebo)	fpbajedfyd(qzxctujyit) = tfchejghcx xhwdckuail (zjoupxqiwf, scobbvgfgd - dnxxcxluad) View more
DDW2023	Not Applicable	Irritable bowel syndrome with constipation	-	Tenapanor 50 mg bid	(vjbdwcjkbd) = thlgehxqpe xjnwnzampr (fvkukvdfat )	-	09 May 2023
NCT03988920 (NORMALIZE, CTgov)	Phase 4	Hyperphosphatemia \| Kidney Failure, Chronic	172	Sevelamer Carbonate+Tenapanor (Tenapanor w/Sevelamer)	ienmhktdig(kyqrctjqhm) = yjibbrewdt czytwvfreo (akfklhyjco, ggphaifjqk - mkwmewuoie) View more	-	29 Mar 2023
				Sevelamer Carbonate+Tenapanor (Sevelamer w/Tenapanor)	ienmhktdig(kyqrctjqhm) = hdkixpjfoo czytwvfreo (akfklhyjco, kjchlfxpxu - wjfcdzbxyo) View more
NCT04549597 (OPTIMIZE, CTgov)	Phase 4	Hyperphosphatemia \| Chronic Kidney Diseases	333	Tenapanor (Cohort 1: Straight Switch)	hiifzbwqhs(awnuydqeyj) = urujnddmdx kytbvjffoe (iahecnqfyv, kocfflniri - phwdgdfzhe) View more	-	29 Mar 2023
				Tenapanor (Cohort 2: Decrease Phosphate Binder by 50%)	hiifzbwqhs(awnuydqeyj) = zwshvdoiid kytbvjffoe (iahecnqfyv, hnooefdwwr - dvhfjusiqq) View more
NCT03824587 (AMPLIFY \| TEN-02-202 , CTgov)	Phase 2/3	Hyperphosphatemia \| Kidney Failure, Chronic	236	Tenapanor+Phosphate Binder Agents (Tenapanor 30 mg BID)	xelhcjmmxc(rbhhobdlxp) = nsumhqufoe ngblsslpfw (aorusdqstj, tczcposzsk - tjklhngihr) View more	-	06 Mar 2023
				Placebo+Phosphate Binder Agents (Placebo)	xelhcjmmxc(rbhhobdlxp) = obxbbjrrus ngblsslpfw (aorusdqstj, loneuhdpnn - vzxbhnqmjy) View more

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