Delving into the Latest Updates on Sevelamer Carbonate with Synapse

Overview

Basic Info

Drug Type

Polymer

Synonyms

Renvela(TN), sevelamer, Sevelamer carbonate (USAN)

+ [7]

Target

Phosphates

Action

modulators

Mechanism

Phosphates modulators(Phosphates modulators)

Therapeutic Areas

Endocrinology and Metabolic DiseaseUrogenital Diseases

Active Indication

Chronic Kidney Disease-Mineral and Bone DisorderHyperphosphatemiaChronic Kidney Diseases

Inactive Indication

Cardiovascular DiseasesDiabetes Mellitus, Type 2Hyperparathyroidism, Secondary+ [1]

Originator Organization

Genzyme Corp.

Active Organization

Sanofi Winthrop Industrie SA

Shandong Xinhua Pharmaceutical Co., Ltd.

Genzyme Corp.

+ [2]

Inactive Organization

Nanjing Hencer Pharmacy Co. Ltd.

Sanofi

License Organization

Sanofi-Aventis SA

Handok, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (19 Oct 2007),

Chronic Kidney Diseases

Regulation-

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Structure/Sequence

Molecular FormulaC7H14ClNO4

InChIKeyPADGNZFOVSZIKZ-UHFFFAOYSA-N

CAS Registry845273-93-0

Renal fibrosis is a common feature of chronic kidney disease (CKD) and is characterized by interstitial fibrotic tissue deposition, impaired renal function, and interstitial inflammation. To date, there are no clinically effective therapeutic agents specifically approved for the treatment of renal fibrosis. Sevelamer, as a phosphate binder, was approved to treat hyperphosphatemia and was recently shown to have antifibrotic effects in preclinical studies. In this study, we established a folic acid (FA)-induced renal interstitial fibrosis mouse model and an in vitro model using human kidney-2 (HK-2) cells to evaluate the therapeutic effects and mechanisms of sevelamer in renal fibrosis. Our results revealed that sevelamer reduced serum phosphate levels in fibrotic mice and improved renal function by restoring serum creatinine (Scr), blood urea nitrogen (BUN), and uric acid (UA) levels. Sevelamer significantly alleviated tubular injury, reduced extracellular matrix (ECM) accumulation, decreased the expression of inflammatory cytokines (IL-1β, IL-6, and TNF-α) in the serum, and mitigated renal inflammation. In vitro, sevelamer-induced phosphate deprivation inhibited HK-2 cell migration and epithelial‒mesenchymal transition (EMT), reducing the expression of fibrosis-associated proteins. Mechanistic studies revealed that low-phosphate stress induced by sevelamer suppressed the phosphorylation of IκBα and NF-κB-p65, inhibiting nuclear factor kappa B (NF-κB) signaling both in vivo and in vitro. As a result, sevelamer-mediated low-phosphate stress improved renal function, reduced ECM deposition, suppressed the expression of EMT markers in mouse kidneys and HK-2 cells, decreased inflammatory cytokine release, and attenuated NF-κB pathway activation. Sevelamer may be a potential therapeutic agent for the treatment of renal fibrosis.

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 ; Elbahnasawy, Enas ; Elkalashy, Ahmed ; Karakala, Nithin ; 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 Apr 2025·Nephrologie & Therapeutique

The effects of resins added to the milk of children suffering from chronic kidney disease: a clinical relevance to control potassium and phosphate levels?

Article

Author: Ranchin, Bruno ; Naud, Corentin ; Bechara, Rouba ; Chambon, Véronique ; de Mul, Aurélie ; Bacchetta, Justine

Background:

In infants with chronic kidney disease (CKD), the management of nutrition and growth is highly challenging, particularly compared to older children. Management of hyperkalemia and hyperphosphatemia is difficult, and incorporating potassium and phosphate binders directly in formulas could be beneficial, as it avoids direct ingestion of resins by infants.

Materials and methods:

We conducted a study using Gallia® standard first-stage infant formula and Pregestimil®. We added either carbonate sevelamer (Renvela®, 200, 400 or 800 mg) or polystyrene sulfonate (Resikali®, 2000, 4000 or 8000 mg) to 90 ml of formula. Additionally, we evaluated the combined use of the resins with Gallia® by adding in 90 mL 200 mg/2000 mg, 400 mg/4000 mg, and 200 mg/4000 mg of Renvela® and Resikali®, respectively. The Milk was decanted for 10 minutes, and the resulting supernatants were weighted and analyzed for osmolality and pH. Sodium, potassium, chlore, bicarbonate, magnesium, glucose, calcium, phosphate, protein, cholesterol, triglycerides, iron, folate, vitamin B12 levels were measured after centrifugation.

Results:

With polystyrene sulfonate, potassium levels in milk decreased in a dose-dependent manner, by 36%, 52% and 68%, respectively. Polystyrene sulfonate also reduced magnesium levels and increased both calcium concentration (from 9.7 to 21 mmol/L) and osmolality (from 359 to 423 mOsm/kg). No significant effect on phosphate was observed. Sevelamer decreased both calcium and phosphate concentrations in a dose-dependent manner, by 14%, 26% and 29%, and by 24%, 36% and 40%, respectively. Sevelamer also increased pH from 6.9 to 9.1, and decreased folate levels by 32%, 66% and 81% respectively, from 465 to 88 mmol/L. The combined use of sevelamer and polystyrene sulfonate results in decreased levels of potassium (by 45%, 59% and 59%, respectively), phosphate (by 38%, 39% and 36%, respectively), and folate, albeit with a slighter increase in pH. Osmolality remained unchanged and no other relevant differences were observed.

Conclusion:

Pretreating formulas with resins is a reproducible and straightforward method when specific diets for CKD are unavailable. However, it is important to keep in mind that resins may impact the overall composition (osmolality) and the concentration of other nutrients (folates).

14

News (Medical) associated with Sevelamer Carbonate

18 Mar 2026

·www.biospace.com

R1 Leads Busy Fundraising Day With $77.5M Series A Raise for Kidney Disease

iStock, Nauval Wildani Alongside R1 Therapeutics, Mestag Therapeutics and iDEL Therapeutics also brought in money on Tuesday, helping to push their respective cancer portfolios forward. Biopharma had a fruitful fundraising day on Tuesday, led by R1 Therapeutics’ oversubscribed series A haul to advance novel treatments for kidney diseases. The California-based startup is coming onto the biopharma scene with $77.5 million in initial funds, according to a Tuesday news release , as well as a potentially first-in-class drug to help temper phosphate levels in patients with chronic kidney disease. Abingworth, F-Prime and DaVita Venture Group co-led the moneymaking push. R1 will use its series A proceeds to advance the global development of AP306, a pan phosphate transporter inhibitor that the biotech claims is “the only agent that blocks the ‘active’ transport” of phosphate. Other phosphate-lowering agents only passively restrict its transport, R1 said. AP306 was originally developed by Chugai and came to R1 via the China-based biotech Alebund Pharmaceuticals, which gave R1 an exclusive worldwide sublicense to the drug—though the specific financial terms of this agreement remain under wraps. Alebund will retain ownership over AP306 in the Greater China region. AP306 has already completed Phase 2a testing in China, with results in February 2025 demonstrating a significant decrease from baseline in serum phosphate levels. Compared with Sanofi’s phosphate binder Renvela, approximately 20% more patients on AP306 achieved the range of phosphate levels recommended in the Kidney Disease: Improving Global Outcomes guidelines. R1 plans to collaborate with Alebund on a global Phase 2b study for AP306, set to begin later this year, according to the press release. The drug “represents a fundamentally new approach to treating hyperphosphatemia,” R1 CEO Krishna Polu said in a statement. “AP306 has the potential to deliver superior efficacy with substantially lower pill burden compared to current phosphate binder therapies.” Also bringing in money on Tuesday was Mestag Therapeutics, which raised $40 million in a push backed by some of the industry’s biggest names, including Johnson & Johnson, Forbion and Google Ventures. The financing will help bankroll the Phase 1 STARLYS study of Mestag’s bispecific antibody for solid tumors. STARLYS is set to start mid-2026, according to the biotech’s press announcement. iDEL Therapeutics also closed its seed round on Tuesday, raising €9 million (about $10.4 million). The company’s technology involves directly delivering cancer drugs into the cytosol of cancer cells, an approach that can be applied to both large and small molecules. Thursday’s proceeds will help push two proprietary lead programs toward the clinic. IDEL is backed by BiomedVC with participation from NRW.Venture, KHAN Technology Transfer Fund II and Gründerfonds Ruhr.

Phase 1Phase 2License out/inClinical Result

17 Mar 2026

·firstwordpharma.com

Kidney biotech R1 Therapeutics emerges with $77.5M, new way to tackle phosphate control in CKD

R1 Therapeutics launched Tuesday with $77.5 million in hand and a lead asset called AP306 that it believes will improve outcomes for chronic kidney disease (CKD) patients by controlling hyperphosphataemia via a new mechanism. Rather than depending on the burdensome binder drugs patients have used for years, the California-based biotech aims to block phosphate absorption directly in the gut.It also announced a partnership with Alebund Pharmaceuticals to license global rights to AP306 outside China. Although exact terms of the deal weren't disclosed, Alebund said that it is eligible to receive milestone payments of up to low triple-digit millions of US dollars, as well as tiered sales royalties in the low double-digit percentage range. Alebund added that it also holds "a substantial non-dilutive equity interest in R1."AP306, also known as EOS789, is designed to inhibit all three phosphate transporters — NaPi-IIb, PiT-1 and PiT-2 — blocking phosphate uptake in the gut. It was discovered by Chugai Pharmaceutical and licensed to Alebund in 2021 for an undisclosed upfront payment and potential milestones.Current phosphate binders have been the standard of care for 60 years, but are limited by low binding capacity, high pill burden and poor gastrointestinal (GI) tolerability. More recently, Ardelyx's Xphozah (tenapanor) was approved by the FDA to lower serum phosphorus in CKD patients on dialysis as an add-on therapy that targets the NHE3 sodium transporter, though R1 says managing hyperphosphataemia continues to be an area of high unmet need."By blocking the active transport of phosphate through three different phosphate transporters in the GI tract, initial clinical studies suggest AP306 has the potential to deliver superior efficacy with substantially lower pill burden compared to current phosphate binder therapies," said R1 CEO Krishna Polu, adding the experimental drug, if successful, "should redefine the class of phosphate lowering therapies."Advancing to Phase IIbIn a Phase IIa study in dialysis patients, AP306 met its primary endpoint, reducing serum phosphate by 2.51 mg/dL from baseline at 12 weeks in haemodialysis patients with hyperphosphataemia, compared with a 1.08 mg/dL reduction for Sanofi's phosphate binder Renagel/Renvela (sevelamer). The study also suggested AP306 was safe and well tolerated, with a markedly lower dose burden than standard binders, which often require patients to take up to nine to 15 pills a day, R1 says on its website.A Phase IIb study of AP306 as monotherapy for hyperphosphatemia in patients with CKD is slated to start later this year in the US and China, with Alebund serving as a collaborative development partner on the drug.The oversubscribed series A financing was co-led by Abingworth, F-Prime and DaVita Venture Group, with participation from Curie.Bio, SymBiosis and US Renal Care.

Phase 2Clinical ResultPhase 1License out/in

17 Mar 2026

·www.biopharmadive.com

R1 starts up with $78M, aiming for a better kidney drug

People with failing kidneys deal with a host of health issues, among them a complication that drives up phosphorus levels so high it can weaken bones and damage the heart.This hyperphosphatemia is common among those whose chronic kidney disease has progressed to the point of needing dialysis. But their treatment options can be tough to tolerate and involve taking multiple pills with each meal.R1 Therapeutics, a new biotechnology startup based in Redwood City, California, wants to change that. Armed with $77.5 million in Series A funding, the company has signed a deal with a Chinese pharmaceutical firm to bring into further clinical testing a drug it believes can advance upon available therapies for the condition.Typical treatments for hyperphosphatemia bind to the mineral in the gut. One, sold as Renvela, attaches to phosphate and keeps it from being absorbed in the bloodstream. Another,Xphozah,prevents phosphate buildup by targeting a protein in the gastrointestinal tract that is responsible for transport between cells.Krishna Polu, R1s co-founder and CEO, argues that theres room for more potent treatments. The company says it might have one in a small molecule codenamed AP306, which aims at multiple targets involved in actively transporting phosphate between cells.R1 claims this approach could yield a more effective and tolerable drug. A Phase 2 studyrun in China and testing a thrice-daily regimen of AP306 against a phosphate binder showed that R1s medicine was superior at lowering phosphorus levels after 12 weeks, as well as bringing people into what would qualify as a normal range. It hasn't yet clearly proven to have a safety advantage in clinical testing.When we talk to practicing nephrologists and those who are providing dialysis care for patients, what they tell us they're most excited about is that the pill burden is going to be substantially lower than the requirements with traditional phosphate binders,Polu said.AP306 is set to enter Phase 2b testing later this year in patients with dialysis, with data expected in 2027.The drug was originally developed by Chugai Pharmaceutical and then licensed to Shanghai-based Alebund Pharmaceuticals in 2021. R1 acquired righs to the therapy, outside of China, at the end of 2025, Polu said.R1s venture backers include Abingworth, F-Prime Capital, DaVita Venture Group, Curie.Bio, SymBiosis and U.S. Renal Care.Polu, meanwhile, previously helped form Mineralys Therapeutics, which is now publicly traded, and a company called Renalys Pharma that Chugai acquired last year. '

Phase 2Acquisition

100 Deals associated with Sevelamer Carbonate

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External Link

KEGG	Wiki	ATC	Drug Bank
D06642	Sevelamer Carbonate	V03AE02	DB00658

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Kidney Disease-Mineral and Bone Disorder	European Union	Sanofi Winthrop Industrie SA	15 Jan 2015
Chronic Kidney Disease-Mineral and Bone Disorder	Iceland	Sanofi Winthrop Industrie SA	15 Jan 2015
Chronic Kidney Disease-Mineral and Bone Disorder	Liechtenstein	Sanofi Winthrop Industrie SA	15 Jan 2015
Chronic Kidney Disease-Mineral and Bone Disorder	Norway	Sanofi Winthrop Industrie SA	15 Jan 2015
Hyperphosphatemia	European Union	Sanofi Winthrop Industrie SA	09 Jun 2009
Hyperphosphatemia	Iceland	Sanofi Winthrop Industrie SA	09 Jun 2009
Hyperphosphatemia	Liechtenstein	Sanofi Winthrop Industrie SA	09 Jun 2009
Hyperphosphatemia	Norway	Sanofi Winthrop Industrie SA	09 Jun 2009
Chronic Kidney Diseases	United States	Genzyme Corp.	19 Oct 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Kidney Failure, Chronic	Phase 3	France	Genzyme Corp.	01 Oct 2010
Hyperparathyroidism, Secondary	Phase 3	United States	Genzyme Corp.	01 Apr 2010
Cardiovascular Diseases	Phase 2	United Kingdom	Genzyme Corp.	01 Feb 2009
Diabetes Mellitus, Type 2	Clinical	Denmark	Sanofi	01 Feb 2014

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Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04485039 (CTgov)	Phase 4	Smallpox	44	Tecovirimat (TPOXX: Oral Antiviral)	nvmojudtyl(htllrufggb) = wudnhufmbm bohokzofsj (unlqzblieq, 39.6) View more	-	09 Oct 2024
				Tecovirimat+sevelamer carbonate oral tablet (TPOXX: Oral Antiviral and Sevelamer Carbonate)	vkpvlcbmrb(oevzhzbxak) = szjtfujfur gheiwtzuwv (apgtqagwab, qqwlwddivy - nepbkuplyf) View more
NCT03644264 (Pubmed)	Phase 3	Hyperphosphatemia	286	Sucroferric oxyhydroxide	pbhycnyuua(iwkymltcgg) = pzthyibklj roofayofmq (hrucskfjnv )	Positive	20 Jul 2023
				Sevelamer carbonate	pbhycnyuua(iwkymltcgg) = xnwjvarkaq roofayofmq (hrucskfjnv )
NCT03988920 (NORMALIZE, CTgov)	Phase 4	Hyperphosphatemia \| Kidney Failure, Chronic	172	Sevelamer Carbonate+Tenapanor (Tenapanor w/Sevelamer)	embbydimhz = cbviqmbins nggtgllies (nrskebsnfd, ltbzghivtf - fwwigrzhii) View more	-	29 Mar 2023
				Sevelamer Carbonate+Tenapanor (Sevelamer w/Tenapanor)	embbydimhz = rrfqooqiew nggtgllies (nrskebsnfd, owqiqnnplr - fctirgimif) View more
ASN2022	Not Applicable	Chronic Kidney Diseases hyperphosphatemia	-	Sevelamer	fuzihvoovu(wvywhfjnow): HR = 0.84 (95% CI, 0.79 - 0.91) View more	Positive	05 Nov 2022
				Sevelamer (Cardiopulmonary Bypass (CPB))
NCT03001011 (RECOVER \| P0880, CTgov)	Phase 3	Hyperphosphatemia \| Chronic Kidney Diseases	202	Placebo (Placebo)	sfglxdhsjv(ucwhesqwjw) = stisgytugv prvzleddcn (rjtcttdokw, tzqzjfzugr - jhuwykfaag) View more	-	28 Jul 2020
				Sevelamer Carbonate (GZ419831) (Renvela)	sfglxdhsjv(ucwhesqwjw) = moujxncrkn prvzleddcn (rjtcttdokw, mssanlmgna - ftujlqewih) View more
NCT01574326 (Pubmed \| Pediatr Nephrol) Manual	Phase 2	Hyperphosphatemia \| Chronic Kidney Diseases	66	sevelamer carbonate	tmhaowbpcs(nxssgoeycd): difference = -0.90, P-Value = 0.001 View more	Positive	01 Feb 2018
				Placebo
NCT01220843 (FRENCH, Pubmed) Manual	Phase 3	Chronic Kidney Diseases	96	Sevelamer	uschyxdocg(zjcdxlnayy) = vfasbxswvp tbfojppocu (xjgpuztlgc )	Negative	07 Dec 2017
				Placebo	uschyxdocg(zjcdxlnayy) = cytzpofgfi tbfojppocu (xjgpuztlgc )
NCT01238588 (CTgov)	Not Applicable	Hyperphosphatemia \| Inflammation \| Plaque, Atherosclerotic	24	Renvela+Sevelamer Carbonate	jgellaylox(cyokxzzgst) = lwoptcigqg gucskknuvn (fryaduaxfo, ybrcwmltxx - hkssxhjznb) View more	-	21 Jun 2017
NCT00999037 (CTgov)	Not Applicable	Hyperparathyroidism, Secondary \| Chronic Kidney Diseases	18	Sevelamer Carbonate (Renvela)	zpowjumvtv(tepcozumoz) = kpftbqblih cckryhzcjb (rcwxbjzjra, 41) View more	-	31 Mar 2017
				Placebo (Placebo)	zpowjumvtv(tepcozumoz) = uvcpztwrls cckryhzcjb (rcwxbjzjra, 46) View more
NCT01574326 (phase 2 study, ASN2016)	Phase 2	Hyperphosphatemia \| Chronic Kidney Diseases	101	Sevelamer Carbonate	sgjpgtytja(eltbmbcxes) = xrepggvwsv irirftcprs (vqcwsiaryq )	Positive	15 Nov 2016