The goal of this clinical trial is to learn if calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in patients with degenerative heart valve disease and chronic kidney disease (CKD). The main questions it aims to answer are:
* Does Sevelamer lower the progression of heart valve calcification compared to calcium carbonate over 12 months?
* What are the impacts of calcium-phosphorus regulation therapy on major cardiovascular events such as heart failure, cardiovascular death, and the need for valve surgery? Researchers will compare Sevelamer to calcium carbonate to see if Sevelamer is more effective in reducing heart valve calcification.
Participants will:
* Take Sevelamer or calcium carbonate daily for 12 months.
* Undergo echocardiography and CT scans at baseline and after 12 months to assess heart valve calcification.
* Attend follow-up visits at 3, 6, 9, and 12 months to monitor blood tests and adjust treatment as needed.

Start Date01 Mar 2024

Sponsor / Collaborator

National Center for Cardiovascular Diseases

100 Clinical Results associated with Sevelamer Hydrochloride

100 Translational Medicine associated with Sevelamer Hydrochloride

100 Patents (Medical) associated with Sevelamer Hydrochloride

657

Literatures (Medical) associated with Sevelamer Hydrochloride

01 Sep 2025·JOURNAL OF RENAL NUTRITION

Gastrointestinal Mucosal Cell Injury Caused by Sevelamer Crystals: Case Series and Literature Review

Review

Author: Ali, Umair ; Singh, Manisha ; Elkalashy, Ahmed ; Karakala, Nithin ; Elbahnasawy, Enas ; Rainwater, Randall R

In end-stage kidney disease (ESKD), hyperphosphatemia occurs secondary to decreased renal elimination with continued intestinal absorption of dietary phosphate. Even in chronic kidney disease, glomerular filtration rate lower than 30 mL/min markedly decreases the filtration of inorganic phosphate and increases its serum level. Sevelamer, a noncalcium phosphate binder, is commonly used to control hyperphosphatemia. Available in 2 forms, sevelamer hydrochloride and sevelamer carbonate, it absorbs phosphate in the gastrointestinal tract and is known to have minimal adverse effects. These are limited to nausea, vomiting, flatulence, and metabolic acidosis, with infrequent significant adverse outcomes. We present a series of 2 patients with ESKD on sevelamer, with lower gastrointestinal bleeding and endoscopic findings of colonic mucosal injuries with histopathological findings of sevelamer crystals deposition. Although reported in gastrology literature, nephrology reports show a paucity of discussion around this increasingly common adverse effect and the need for vigilance in ESKD.

01 Jun 2025·SAGE Open Medical Case Reports

Upadacitinib as a potential management option for diffuse cutaneous systemic sclerosis: A case report

Article

Author: Kirchhof, Mark G. ; Sarfaraz, Sidra ; Chang, Janis

Systemic sclerosis (SSc) is a complex disease involving vasculopathy, immune dysfunction, and fibrosis, with varied clinical presentations that complicate treatment standardization. It often affects multiple organs, including the skin, lungs, gastrointestinal tract, and kidneys. We present a 52-year-old woman with a 14-year history of diffuse cutaneous SSc with severe, treatment-resistant manifestations. She had Raynaud’s disease with digital ulceration and auto-amputation, telangiectasias, sclerodactyly, esophageal scleroderma, interstitial lung disease, and extensive calcinosis requiring multiple surgeries. Her disease remained poorly controlled despite treatment with nintedanib, sevelamer, colchicine, tadalafil, and prior immunosuppressants such as prednisone and mycophenolate mofetil. We initiated a trial of upadacitinib which resulted in improved vascular and cutaneous symptoms. Overall, upadacitinib provided meaningful clinical benefits despite her refractory, multisystem disease.

05 Apr 2025·Cureus Journal of Medical Science

Hyperphosphatemic Familial Tumoral Calcinosis With a Large Hip Mass

Article

Author: Ali, Issa ; Carlan, Steve ; Bernardes, Teresa ; Galili, Yehuda

Hyperphosphatemic familial tumoral calcinosis (HFTC) is a rare autosomal recessive disorder that generally presents in the first two decades of life with ectopic calcification throughout the body. The underlying metabolic disorder is caused by a mutation in a gene responsible for regulating fibroblast growth factor 23 (FGF23) activity. Loss of regulation of FGF23 results in hyperphosphatemia resulting in the characteristic tissue calcinosis deposits, especially in periarticular locations. The diagnosis is made with imaging, hyperphosphatemia, and genetic testing. Medical and surgical treatments are recommended to reduce blood phosphate and remove the masses. A 35-year-old male presented with a painful left lateral hip mass that had been gradually enlarging over the past four months. X-rays showed amorphous calcific densities in the left hip consistent with tumoral calcinosis. Magnetic resonance imaging (MRI) noted a stable complex mass in the left posterior hip and ischio-femoral space consistent with tumoral calcinosis. He had an elevated phosphorus level of 6.0 mg/dL (reference range 2.5 to 4.5 mg/dL). Excision of the mass was successful and genetic testing showed a pathogenic variant in polypeptide N-acetylgalactosaminyltransferase 3 (GALNT3), associated with HFTC. He was treated with diet and sevelamer (phosphate binder), and discharged. This case demonstrates that the detection of the disorder can be delayed by the slow progression of clinical symptoms and tumor calcinosis over time. Ultimately, early awareness of the disease and the mechanisms responsible for the tissue damage are important to limit long-term health consequences, which can include calcifications that ulcerate and limit joint motion. As seen in this patient, the condition often requires repeated surgical interventions. Finally, this is an autosomal recessive inherited disorder, so genetic counseling is an important component of comprehensive care.

News (Medical) associated with Sevelamer Hydrochloride

15 Oct 2025

·www.fiercepharma.com

Particle Dynamics melds with former EuroAPI plant to debut new CDMO Codis

Codis' U.K. facility is located in Haverhill and was acquired by Particle Dynamics in June from Paris-based EuroAPI. Codis, born from the fusion of U.S.-based Particle Dynamics and a U.K. spray drying facility previously operated by EuroAPI, has become one of the latest CDMOs to debut this year.The new company, which also boasts facilities in St. Louis and Seymour, Indiana, has a combined capacity in excess of 5,000 metric tons of spray drying output per year and employs more than 300 workers globally, according to an Oct. 14 press release.In addition to that spray drying capacity, which the CDMO asserts is among the largest anywhere in the world, Codis says it's also equipped to handle commercial-scale work on amorphous solid dispersions, particle engineering and finished dose manufacturing for pharma, consumer health and over-the- counter clients. “Codis is built on a foundation of scale, quality, and global reach,” Nicolas Fortin, Codis’ chief executive, said in the release. “With a total of 40,000 square meters of manufacturing space, three GMP facilities and with 7 regulatory approvals achieved, we are uniquely positioned to help pharmaceutical innovators accelerate therapies from development to market.”The Codis U.K. facility is located in Haverhill and was acquired by Particle Dynamics in June from Paris-based EuroAPI. The sale, for which financials weren’t disclosed, was part of EuroAPI’s FOCUS-27 restructuring plan. The restructuring will see the Sanofi spinout shed some 550 jobs by 2027 and concentrate its operations on four production sites across France, Hungary and Germany. In a testament to the Haverhill site's longstanding position in the pharma supply chain, Codis noted that the facility is one of the world's primary producers of the hyperphosphatemia drug sevelamer. Codis joins the ranks of several other CDMOs that made their debut in 2025. In late September, biologics-minded Rezon Bio arrived on the European contract manufacturing scene with Polish production sites in Gdańsk and in the Warsaw-Duchnice area.Prior to that, Meribel Pharma Solutions launched in April in the U.K. after its financial backer—U.S. private equity firm Blue Wolf Capital—snapped up a string of Recipharm production sites and bought out French contract manufacturer Synerlab.And Meribel’s debut came just three weeks after San Diego-based Artis BioSolutions uncloaked as a new cell and gene therapy CDMO following its acquisition of personalized medicine compatriot Landmark Bio.

Acquisition

14 Oct 2025

·www.prnewswire.com

Codis Launches as Global CDMO for Commercial Spray Drying and Amorphous Solid Dispersions

New global CDMO combines commercial spray drying and particle engineering technologies under one brand. Codis formed through integration of Particle Dynamics and the former EUROAPI site in Haverhill, UK Specializes in aqueous and solvent-based spray drying as well as amorphous solid dispersion (ASD) at commercial scale Global footprint of 40,000 m2 across the US and UK, Codis offers one of the largest commercial spray drying operations worldwide New brand emphasizes quality, compliance, and problem-solving orientation ST. LOUIS, Oct. 14, 2025 /PRNewswire/ -- Codis officially launches as a new global CDMO specializing in commercial-scale spray drying, amorphous solid dispersions (ASD), and particle engineering technologies. Formed through the integration of Particle Dynamics in the US and the Haverhill, UK spray drying facility previously operated by EUROAPI, Codis combines decades of regulatory expertise and manufacturing strength under one brand. With facilities in St. Louis, MO, Seymour, IN and Haverhill, UK, Codis offers: Over 5000 metric tons/year of spray drying output capacity 30 products with 50 pharma global customers 30 years of successful regulatory track record Audited and approved by 6 international regulatory agencies 300+ employees worldwide "Codis is built on a foundation of scale, quality, and global reach," said Nicolas Fortin, Codis CEO. "With a total of 40,000 m2 of manufacturing space, three GMP facilities and with 7 of regulatory approvals achieved, we are uniquely positioned to help pharmaceutical innovators accelerate therapies from development to market." Acquired from EUROAPI in June 2025, Haverhill, UK facility brings over 30 years of expertise in spray drying, continuous flow chemistry, and regulatory compliance. The site also serves as one of the world's primary manufacturers of Sevelamer, underscoring its capability to support high-quality, globally approved products. The name Codis, derived from the Latin codex ("law" or "system"), reflects the company's commitment to compliance, reliability, and problem-solving for its global partners. About Codis Codis is a global CDMO specializing in commercial spray drying, amorphous solid dispersions, particle engineering, and finished dose manufacturing for the pharmaceutical, consumer health, nutraceutical, and OTC sectors. Codis delivers: One of the largest GMP spray drying capacities globally Proven record of regulatory approvals across FDA, EMA, and PMDA Trusted by the world's top pharma companies Learn more at Media Contact: Contact: Connor Halverson Tel: +1 212 366 4455 Email: [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Acquisition

31 Jul 2024

·www.globenewswire.com

Ardelyx Announces Publication of Two Plain Language Summaries from XPHOZAH® (tenapanor) Clinical Trials in Current Medical Research and Opinion

WALTHAM, Mass., July 31, 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 the publication of plain language summaries of results from two clinical trials on XPHOZAH® (tenapanor), NORMALIZE and OPTIMIZE, in Current Medical Research and Opinion. The plain language summaries were developed by the authors to help adult patients with chronic kidney disease receiving dialysis, and their family members and caregivers, better understand some of the safety and efficacy data related to XPHOZAH. 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, blocking phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily. “We are proud to provide the clinical trials results for both the NORMALIZE and OPTIMIZE studies to patients in a format that is both useful and relevant to their needs. Plain language summaries, like these, help patients and their caregivers better understand their options and the potential impact XPHOZAH may have on lowering their serum phosphorus levels,” said Laura Williams, MD MPH, chief medical officer of Ardelyx. “Our entire Ardelyx team would like to express our gratitude to the patients who participated in these clinical trials, whose contributions are now helping other patients better understand the complications associated with elevated serum phosphorus and this new treatment option. We would also like to recognize the study authors who worked with our partners in the patient advocacy community to ensure that these plain language summaries could be made available to our patients.” Current Medical Research and Opinion is an international journal that publishes research focused on new and existing drugs and therapies, best practices in patient care, developments in diagnostic medicine and medical technology, and innovations in medical and scientific publishing. The first article, titled “Tenapanor improves long-term control of high phosphate concentrations in the blood in patients receiving maintenance dialysis: a plain language summary of the NORMALIZE study,” describes results from the NORMALIZE study, is available online and can be found here. The second article, titled “Effectiveness of tenapanor for treating hyperphosphatemia in patients receiving dialysis: a plain language summary of the OPTIMIZE study” provides a review of the OPTIMIZE study, is available online and can be found here. Both articles are summaries of data originally published in Kidney360. 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 NORMALIZE Patients completing the Phase 3 PHREEDOM trial from both the XPHOZAH arm and the sevelamer safety control arm had the option to participate in NORMALIZE, an open-label 18-month extension study. Patients entering the study from the XPHOZAH arm with serum phosphate levels in the normal range were followed with no medication changes. Patients entering the study from the XPHOZAH arm with serum phosphate greater than 4.5 mg/dL had sevelamer tablets added incrementally to achieve normal serum phosphate levels. Patients entering the study from the sevelamer safety control arm had XPHOZAH tablets added to their treatment regimen while reducing sevelamer tablets based on their serum phosphate value to achieve normal serum phosphate levels. The primary objective of the study was to evaluate the ability of XPHOZAH alone or in combination with sevelamer to achieve serum phosphate levels within the normal range (2.5 to 4.5 mg/dL) in patients with CKD on maintenance dialysis whose serum phosphate levels were greater than 6.0 mg/dL at baseline. About OPTIMIZEOPTIMIZE 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. The objective was to evaluate the ability of XPHOZAH, with its novel blocking mechanism, administered as core therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis, alone or in combination with phosphate binders, to achieve target serum phosphorus (s-P) levels ≤5.5 mg/dL. The study enrolled patients with s-P >5.5 and ≤10.0 mg/dL during stable phosphate binder treatment which were randomized in a 1:1 ratio to two different treatment cohorts, as well as patients who were phosphate binder naïve with s-P >4.5 and ≤10.0 mg/dL in a third cohort. 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 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 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. Investor and Media Contacts: Caitlin Lowieclowie@ardelyx.com

Clinical ResultPhase 3Drug ApprovalLicense out/inClinical Study

100 Deals associated with Sevelamer Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01983	Sevelamer Hydrochloride	V03AE02	DB00658

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Kidney Disease-Mineral and Bone Disorder	European Union	Sanofi BV	25 Feb 2015
Chronic Kidney Disease-Mineral and Bone Disorder	Iceland	Sanofi BV	25 Feb 2015
Chronic Kidney Disease-Mineral and Bone Disorder	Liechtenstein	Sanofi BV	25 Feb 2015
Chronic Kidney Disease-Mineral and Bone Disorder	Norway	Sanofi BV	25 Feb 2015
Chronic Kidney Diseases	Australia	Sanofi-Aventis Australia Pty Ltd.	30 Jun 2005
Hyperphosphatemia	European Union	Sanofi	28 Jan 2000
Hyperphosphatemia	Iceland	Sanofi	28 Jan 2000
Hyperphosphatemia	Liechtenstein	Sanofi	28 Jan 2000
Hyperphosphatemia	Norway	Sanofi	28 Jan 2000
Kidney Failure, Chronic	United States	Genzyme Corp.	30 Oct 1998

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02124759 (MicroB1, CTgov)	Phase 2	Insulin Resistance	20	Low Fat diet+Maltodextrin (Placebo)	yczgmpgfwc(wnjcqfjiew) = mkwerlsksi ijukuxpugz (gdhvrmbkgi, 0) View more	-	15 Oct 2021
				Low Fat diet+Sevelamer (Sevelamer)	yczgmpgfwc(wnjcqfjiew) = kjapgjxkpf ijukuxpugz (gdhvrmbkgi, 2.4) View more
NCT02127125 (MicroB2, CTgov)	Phase 2	Insulin Resistance	69	NGT (Lean With NGT-Placebo)	fpixpefkau(kxxvfmoxgz) = xdyhxxsdfe jlihkqzckz (fqhoekvabh, 3.78) View more	-	11 Sep 2020
				maltodextrin+Sevelamer (Lean With NGT-Sevelamer)	fpixpefkau(kxxvfmoxgz) = euhpmfrgpn jlihkqzckz (fqhoekvabh, 2.25) View more
NCT01238588 (CTgov)	Not Applicable	Hyperphosphatemia \| Inflammation \| Plaque, Atherosclerotic	24	Renvela+Sevelamer Carbonate	bsxlwlxldg(qckogpsklp) = pyytesorrc newlxelmcp (fuebzwnasj, gykzzdoiwf - gdloffhqnh) View more	-	21 Jun 2017
Phase III Study (ASN2015)	Phase 3	Hyperphosphatemia	213	PA21 (Sucroferric Oxyhydroxide)	czjjczyetq(enrmfjyqqi) = jqsmygpyqv oyyflaycni (tbrsapvvou ) View more	Positive	03 Nov 2015
				Sevelamer Hydrochloride	czjjczyetq(enrmfjyqqi) = gaqrjwniiu oyyflaycni (tbrsapvvou ) View more
NCT00704483 \| NCT01069692 \| NCT00704678 (SBR759, ASN2010)	Phase 2	Hyperphosphatemia \| Chronic Kidney Diseases	203	SBR759 3.0g	wlaogazsdg(gcstufhoqq) = Similar incidences of SAE/AE were seen with SBR759 and S-HCl (5.2/90.3% vs 4.4/94.1%); no SAE was drug-related. Overall discontinuation rates were lower with SBR759 (11.9% vs 20.6%) as well as discontinuation due to AE (3.7% vs 13.2%). Most frequent AE category with SBR759 and S-HCl was gastrointestinal (GI) disorders (57.5% vs 64.7%). GI AE intensity was mostly mild with SBR759 (mild 45.5%, moderate 11.2%; severe 0.7%) whereas with S-HCl more moderate and severe AEs were reported (mild 30.9%; moderate 27.9%; severe 5.9%). Diarrhea AEs were more frequent with SBR759 (19.4% vs 10.3%); constipation and abdominal distension affected more patients on S-HCl (5.2% and 25.0% vs 3.0% and 25.0%, respectively). Based on Deficiency of Acquired Immune Deficiency Syndrome (DAIDS) grading, majority of diarrhea AE were of grade 1 (lowest severity) with SBR759 and S-HCl (18.7% vs 10.3%) znyscpbijx (zjkcnbfqhl )	Positive	16 Nov 2010
				Sevelamer Hydrochloride 2.4g
NCT00704483 \| NCT01069692 \| NCT00704678 (SBR759, ASN2010)	Phase 3	Hemodialysis complication	203	SBR759	tubipnload(nywjjcmjli) = more frequent with SBR759 smbyvqbpwu (jxnpxduzju ) View more	Positive	16 Nov 2010
				Sevelamer-HCl
Pubmed	Not Applicable	Hemodialysis complication	29	Sevelamer	ehpqujnunj(rcnosvncew) = cgqnpgbijl npafetovaj (tbpzsocjwm ) View more	Positive	01 Mar 2008

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