Accession Number
DB00658  (APRD01226)
Small Molecule

Sevelamer is a phosphate binding drug used to prevent hyperphosphataemia in patients with chronic renal failure. It is marketed by Genzyme under the trade name Renagel.

  • Sevelamer
  • Sévélamer
  • Sevelamero
  • Sevelamerum
External IDs
GT 16026 A / GT 335-012
Product Ingredients
IngredientUNIICASInChI Key
Sevelamer carbonate9YCX42I8IU845273-93-0PADGNZFOVSZIKZ-UHFFFAOYSA-N
Sevelamer hydrochlorideGLS2PGI8QG152751-57-0Not applicable
Product Images
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Intelli-sevelamerTabletOralIntellipharm IncNot applicableNot applicableCanada
RenagelTablet800 mgOralSanofi Aventis2001-11-21Not applicableCanada
RenagelTablet800 mg/1OralGenzyme Corporation2008-06-06Not applicableUs58468 002120180907 15195 1a6on42
RenagelTablet800 mg/1OralCardinal Health2008-06-062018-05-11Us58468 0021 01 nlmimage10 cb1c6593
RenagelTablet400 mg/1OralGenzyme Corporation2008-06-062020-03-01Us
RenagelTablet400 mg/1OralCardinal Health2008-06-062018-05-11Us
RenagelTablet800 mg/1OralRemedy Repack2013-05-152013-05-16Us
RenagelTablet400 mg/1OralCarilion Materials Management2008-06-06Not applicableUs
RenagelTablet800 mg/1OralDoh Central Pharmacy2009-07-01Not applicableUs53808 077720180913 8702 1t9hnek
RenagelTablet800 mg/1OralAphena Pharma Solutions Tennessee, Inc.2008-06-06Not applicableUs
Additional Data Available
  • Application Number
    Application Number

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  • Product Code
    Product Code

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Generic Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Accel-sevelamerTabletOralAccel Pharma Inc2017-11-08Not applicableCanada
Sevelamer CarbonatePowder, for suspension2.4 g/1OralWinthrop U.S.2018-01-01Not applicableUs
Sevelamer CarbonatePowder, for suspension0.8 g/1OralWinthrop U.S.2018-01-01Not applicableUs
Sevelamer CarbonateTablet, film coated800 mg/1OralTWi Pharmaceuticals, Inc.2019-09-30Not applicableUs
Sevelamer CarbonateTablet, film coated800 mg/1OralNorthStar Rx LLC2018-06-06Not applicableUs
Sevelamer CarbonateTablet, film coated800 mg/1OralWinthrop U.S.2018-02-01Not applicableUs
Sevelamer CarbonateTablet, film coated800 mg/1OralAvKARE2017-11-10Not applicableUs
Sevelamer CarbonateTablet, film coated800 mg/1OralAtlantic Biologicals Corp.2018-06-27Not applicableUs
Sevelamer CarbonateTablet, film coated800 mg/1OralREMEDYREPACK INC.2018-04-09Not applicableUs
Sevelamer carbonateTablet, film coated800 mg/1OralWilshire Pharmaceuticals, Inc.2019-03-21Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

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International/Other Brands
Phosblock (Kyowa Hakko Kirin)
CAS number
Average: 149.619
Monoisotopic: 149.060741718
Chemical Formula
InChI Key
2-(chloromethyl)oxirane; prop-2-en-1-amine



For the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis.

Associated Conditions

Patients with end-stage renal disease (ESRD) retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. When the product of serum calcium and phosphorus concentrations (Ca x P) exceeds 55 mg2/dL2, there is an increased risk that ectopic calcification will occur. Hyperphosphatemia plays a role in the development of secondary hyperparathyroidism in renal insufficiency. An increase in parathyroid hormone (PTH) levels is characteristic of patients with chronic renal failure. Increased levels of PTH can lead to osteitis fibrosa, a bone disease. A decrease in serum phosphorus may decrease serum PTH levels. Treatment of hyperphosphatemia includes reduction in dietary intake of phosphate, inhibition of intestinal phosphate absorption with phosphate binders, and removal of phosphate with dialysis. Sevelamer taken with meals has been shown to decrease serum phosphorus concentrations in patients with ESRD who are on hemodialysis. In vitro studies have shown that the capsule and tablet formulations bind phosphate to a similar extent. Sevelamer treatment also results in a lowering of low-density lipoprotein (LDL) and total serum cholesterol levels.

Mechanism of action

Sevelamer prevents hyperphosphatemia by binding to dietary phosphate in the gut, preventing its absorption and thus decreasing serum parathyroid hormone levels.

Additional Data Available
Adverse Effects

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Additional Data Available

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Blackbox Warnings

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Not absorbed following oral administration, however no absorption studies have been performed in patients with renal disease. Sevelamer may bind to dietary phosphates and prevent its gastrointestinal absorption when sevelamer is administered in combination with food.

Volume of distribution
Not Available
Protein binding
Not Available
Not Available
Route of elimination
Not Available
Half life
Not Available
Not Available

Sevelamer has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. Sevelamer has been given in average doses up to 13 grams per day to hemodialysis patients. There are no reported overdosages of sevelamer in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.

Affected organisms
  • Humans and other mammals
Not Available
Pharmacogenomic Effects/ADRs
Not Available


Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
(R)-warfarinSevelamer can cause a decrease in the absorption of (R)-warfarin resulting in a reduced serum concentration and potentially a decrease in efficacy.
(S)-WarfarinSevelamer can cause a decrease in the absorption of (S)-Warfarin resulting in a reduced serum concentration and potentially a decrease in efficacy.
1alpha-Hydroxyvitamin D5The serum concentration of 1alpha-Hydroxyvitamin D5 can be decreased when it is combined with Sevelamer.
1alpha,24S-Dihydroxyvitamin D2The serum concentration of 1alpha,24S-Dihydroxyvitamin D2 can be decreased when it is combined with Sevelamer.
4-hydroxycoumarinSevelamer can cause a decrease in the absorption of 4-hydroxycoumarin resulting in a reduced serum concentration and potentially a decrease in efficacy.
5-(2-methylpiperazine-1-sulfonyl)isoquinolineSevelamer can cause a decrease in the absorption of 5-(2-methylpiperazine-1-sulfonyl)isoquinoline resulting in a reduced serum concentration and potentially a decrease in efficacy.
AceclofenacSevelamer can cause a decrease in the absorption of Aceclofenac resulting in a reduced serum concentration and potentially a decrease in efficacy.
AcemetacinSevelamer can cause a decrease in the absorption of Acemetacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
AcenocoumarolSevelamer can cause a decrease in the absorption of Acenocoumarol resulting in a reduced serum concentration and potentially a decrease in efficacy.
AcetazolamideSevelamer can cause a decrease in the absorption of Acetazolamide resulting in a reduced serum concentration and potentially a decrease in efficacy.
Additional Data Available
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Food Interactions
Not Available


Synthesis Reference

Deepak Anant Hedge, Varsha Shashank Choudhary, Venkatasubramanian Radhakrjshnan Tarur, Dhananjay Govind Sathe, Harish Kashinath Mondkar, Samadhan Daulat Patil, Sasikumar Mohan Thoovara, Yogesh Sharad Bhide, "Process for the Preparation of Sevelamer Hydrochloride and Formulation Thereof." U.S. Patent US20090280178, issued November 12, 2009.

General References
Not Available
External Links
Human Metabolome Database
PubChem Compound
PubChem Substance
RxList Drug Page Drug Page
ATC Codes
V03AE02 — Sevelamer
AHFS Codes
  • 40:18.19 — Phosphate-removing Agents
FDA label
Download (36.4 KB)

Clinical Trials

Clinical Trials
0CompletedScreeningChronic Kidney Disease (CKD)1
1CompletedNot AvailableHealthy Volunteers1
1CompletedBasic ScienceChronic Renal Failure (CRF)1
1CompletedTreatmentDiabetic Nephropathies1
1CompletedTreatmentHealthy Volunteers2
1Not Yet RecruitingTreatmentHealthy Volunteers1
2Active Not RecruitingTreatmentInsulin Sensitivity2
2CompletedPreventionCardiovascular Heart Disease / Chronic Renal Failure (CRF)1
2CompletedTreatmentChronic Kidney Disease (CKD)5
2CompletedTreatmentChronic Kidney Disease (CKD) / Hyperphosphataemia2
2CompletedTreatmentChronic Renal Failure (CRF)2
2CompletedTreatmentDiabetic Nephropathies1
2CompletedTreatmentHigh Cholesterol1
2CompletedTreatmentHuman Immunodeficiency Virus Type 1 (HIV-1) Infection1
2CompletedTreatmentHyperparathyroidism, Secondary / Renal Osteodystrophy1
2CompletedTreatmentHyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy1
2CompletedTreatmentRenal Failure1
3Active Not RecruitingTreatmentHyperphosphataemia1
3CompletedPreventionHyperphosphataemia / Renal Failure1
3CompletedTreatmentChronic Kidney Disease (CKD)1
3CompletedTreatmentChronic Kidney Disease (CKD) / Chronic Kidney Disease on Hemodialysis1
3CompletedTreatmentChronic Kidney Disease (CKD) / Dialysis therapy / Hyperphosphataemia1
3CompletedTreatmentChronic Kidney Disease (CKD) / Hyperparathyroidism1
3CompletedTreatmentChronic Kidney Disease (CKD) / Hyperphosphataemia2
3CompletedTreatmentChronic Kidney Disease (CKD) / Peritoneal dialysis therapy1
3CompletedTreatmentChronic Kidney Disease (CKD) / Impaired kidney function / Renal Dialysis1
3CompletedTreatmentChronic Kidney Disease Requiring Chronic Dialysis2
3CompletedTreatmentChronic Renal Failure (CRF)2
3CompletedTreatmentESRD / Hyperphosphataemia1
3CompletedTreatmentEnd-Stage Renal Disease (ESRD) / Kidney Diseases / Renal Insufficiency,Chronic1
3CompletedTreatmentHemodialysis Treatment / Hyperphosphataemia1
3CompletedTreatmentHemodialysis-dependent chronic kidney disease (HDD-CKD)1
3Not Yet RecruitingTreatmentCKD Stage 3b / Stage 4 Chronic Kidney Disease1
3Not Yet RecruitingTreatmentHyperphosphataemia1
3RecruitingTreatmentChronic Kidney Disease Requiring Chronic Dialysis / Hyperphosphataemia1
3RecruitingTreatmentEnd Stage Renal Disease (ESRD) / ESRD / Hyperphosphataemia1
3TerminatedTreatmentChronic Kidney Disease (CKD) / Hyperphosphataemia1
3TerminatedTreatmentChronic Renal Failure (CRF)1
3TerminatedTreatmentChronic Renal Failure (CRF) / Hemodialysis Treatment1
3Unknown StatusTreatmentChronic Kidney Disease Stages 3-51
4CompletedPreventionVascular Diseases1
4CompletedPreventionWe Investigated the Relationship Between Plasma FGF23 Levels and Endothelial Dysfunction in a Sizable Series of Incident Stage 3-4 CKD Patients1
4CompletedTreatmentArteriosclerosis / Calcinosis / Hyperparathyroidism, Secondary1
4CompletedTreatmentCardiovascular Events / Hemodialysis Treatment / Hyperphosphataemia1
4CompletedTreatmentChronic Kidney Disease (CKD)3
4Enrolling by InvitationTreatmentEnd Stage Renal Disease (ESRD) / Hyperphosphataemia1
4TerminatedPreventionChronic Kidney Disease (CKD)1
Not AvailableActive Not RecruitingNot AvailableHyperphosphataemia / Hypophosphatemia, Familial / Hypovitaminosis D1
Not AvailableCompletedNot AvailableAcute Bacterial Exacerbation of Chronic Bronchitis (ABECB) / Acute Bacterial Sinusitis (ABS) / Acute Decompensated Heart Failure (ADHF) / Acute Pyelonephritis / Adenovirus / Adjunct to general anesthesia therapy / Adrenal Insufficiency / Airway Swelling / Anaesthesia therapy / Anxiety / Anxiolysis / Autism, Early Infantile / Autistic Disorder / Bartonellosis / Benzodiazepine Withdrawal / Benzodiazepines / Bipolar Disorder (BD) / Bloodstream Infections / Bone and Joint Infections / Bradycardia / Brain Swelling / Bronchospasm / Brucellosis / Cardiac Arrest (CA) / Central Nervous System Infections / Cholera / Chronic Bacterial Prostatitis / Chronic Kidney Disease (CKD) / Community Acquired Pneumonia (CAP) / Complicated Urinary Tract Infection / Convulsions / Cytomegalovirus Retinitis / Drug hypersensitivity reaction / Dysrhythmia, Cardiac / Early-onset Schizophrenia Spectrum Disorders / Edema / Endocarditis / Epilepsies / Fibrinolytic Bleeding / Flu caused by Influenza / Gastroparesis / Gram-negative Infection / Gynaecological infection / Headache / Heart Failure / Heavy Menstrual Bleeding / Hemophilia / Herpes Simplex Virus / High Blood Pressure (Hypertension) / High Cholesterol / Hyperaldosteronism / Hyperlipidemias / Hypokalemia / Hypotension / Infantile Hemangiomas / Infection / Infection caused by staphylococci / Inflammatory Conditions / Inflammatory Reaction / Influenza Treatment or Prophylaxis / Inhalational Anthrax (Post-Exposure) / Insomnia / Intra-Abdominal Infections / Life-threatening Fungal Infections / Lower Respiratory Tract Infection (LRTI) / Meningitis, Bacterial / Methicillin Resistant Staphylococcus Aureus (MRSA) / Migraine / Muscle Spasms / Nausea / Neuromuscular Blockade / Neutropenia / Nosocomial Pneumonia / Opioid Addiction / Pain / Plague / Pneumonia / Prophylaxis / Psittacosis / Pulmonary Arterial Hypertension (PAH) / Q Fever / Reflux / Relapsing Fever / Rocky Mountain Spotted Fever / Schizophrenia / Sedation / Seizures / Sepsis / Skeletal Muscle Spasms / Skin and skin-structure infections / Skin and Subcutaneous Tissue Bacterial Infections / Stable Angina (SA) / Thromboprophylaxis / Thrombotic events / Toxic effect of hydrocyanic acid and cyanides / Trachoma / Treatment-resistant Schizophrenia / Tularemia / Typhus Fever / Uncomplicated Skin and Skin Structure Infections / Uncomplicated Urinary Tract Infections / Urinary Tract Infection / Vomiting / Withdrawal1
Not AvailableCompletedNot AvailableChronic Kidney Disease (CKD) / Hyperphosphataemia1
Not AvailableCompletedBasic ScienceType 2 Diabetes Mellitus2
Not AvailableCompletedDiagnosticHigh Blood Pressure (Hypertension)1
Not AvailableCompletedPreventionChronic Kidney Disease (CKD)1
Not AvailableCompletedPreventionHyperparathyroidism, Secondary1
Not AvailableCompletedPreventionRenal Failure1
Not AvailableCompletedTreatmentCardiovascular Mortality1
Not AvailableCompletedTreatmentEnd Stage Renal Disease (ESRD) / Hemodialysis Treatment / Intimal Media Thickness1
Not AvailableCompletedTreatmentEndstage Renal Disease1
Not AvailableNot Yet RecruitingNot AvailableAdrenal Insufficiency / Arrhythmia / Asthma in Children / Chronic Lung Disease of Prematurity / Control of Serum Phosphorus / Edematous Conditions / Fibrinolysis; Hemorrhage / Heart Failure / Hemophilia Prior to Tooth Extraction / High Blood Pressure (Hypertension) / Hypermenorrhea / Hypertension, Resistant to Conventional Therapy / Hypokalemia / Insomnia / Pain / Pneumonia / Primary Hyperaldosteronism / Pulmonary Arterial Hypertension (PAH) / Skin-structure infections / Urinary Tract Infections in Children1
Not AvailableRecruitingBasic ScienceType 2 Diabetes Mellitus1
Not AvailableRecruitingSupportive CareHyperparathyroidism, Secondary1
Not AvailableRecruitingTreatmentAtherosclerosis / Cardiovascular Heart Disease / Dialysis therapy / Hyperphosphataemia / Inflammatory Reaction1
Not AvailableTerminatedTreatmentObesity and Glomerulopathy1
Not AvailableWithdrawnTreatmentChronic Renal Failure (CRF) / End-Stage Renal Disease (ESRD) / Hyperphosphataemia / Insulin Resistance1
Not AvailableWithdrawnTreatmentHaemodialyzed Patients / Hyperphosphataemia1


  • Genzyme corp
  • Genzyme Corporation
  • Atlantic Biologicals Corporation
  • Cardinal Health
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  • Physicians Total Care Inc.
  • Prepak Systems Inc.
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  • Resource Optimization and Innovation LLC
  • Southwood Pharmaceuticals
  • Tya Pharmaceuticals
  • Vangard Labs Inc.
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Dosage forms
CapsuleOral403 mg
TabletOral400 mg/1
TabletOral400 mg
TabletOral800 mg/1
TabletOral800 mg
Powder, for suspensionOral0.8 g
Powder, for suspensionOral1.6 g
Powder, for suspensionOral2.4 g
Tablet, film coatedOral800 mg
Tablet, film coatedOral800 mg/1
Powder, for suspensionOral0.8 g/1
Powder, for suspensionOral2.4 g/1
Powder, for suspensionOral2400 mg/1
Powder, for suspensionOral800 mg/1
Tablet, film coatedOral400 mg/1
Tablet, film coatedParenteral800 mg/1
Unit descriptionCostUnit
Renagel 800 mg tablet2.41USD tablet
Renvela 800 mg tablet2.17USD tablet
Renagel 400 mg tablet1.66USD tablet
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patent NumberPediatric ExtensionApprovedExpires (estimated)
Additional Data Available
  • Filed On
    Filed On

    The date on which a patent was filed with the relevant government.

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Experimental Properties
water solubilityInsolubleNot Available
logP0.559Not Available
Predicted Properties
pKa (Strongest Basic)-4.2ChemAxon
Physiological Charge0ChemAxon
Hydrogen Acceptor Count1ChemAxon
Hydrogen Donor Count0ChemAxon
Polar Surface Area12.53 Å2ChemAxon
Rotatable Bond Count2ChemAxon
Refractivity20.06 m3·mol-1ChemAxon
Polarizability8.38 Å3ChemAxon
Number of Rings1ChemAxon
Rule of FiveYesChemAxon
Ghose FilterNoChemAxon
Veber's RuleYesChemAxon
MDDR-like RuleNoChemAxon
Predicted ADMET features
Human Intestinal Absorption+0.9908
Blood Brain Barrier+0.9723
Caco-2 permeable+0.5783
P-glycoprotein substrateNon-substrate0.7654
P-glycoprotein inhibitor INon-inhibitor0.921
P-glycoprotein inhibitor IINon-inhibitor0.9399
Renal organic cation transporterNon-inhibitor0.7531
CYP450 2C9 substrateNon-substrate0.8823
CYP450 2D6 substrateNon-substrate0.8029
CYP450 3A4 substrateNon-substrate0.7617
CYP450 1A2 substrateNon-inhibitor0.5084
CYP450 2C9 inhibitorNon-inhibitor0.7543
CYP450 2D6 inhibitorNon-inhibitor0.839
CYP450 2C19 inhibitorNon-inhibitor0.5583
CYP450 3A4 inhibitorNon-inhibitor0.8711
CYP450 inhibitory promiscuityLow CYP Inhibitory Promiscuity0.6708
Ames testAMES toxic0.9498
CarcinogenicityCarcinogens 0.5468
BiodegradationNot ready biodegradable0.889
Rat acute toxicity2.9282 LD50, mol/kg Not applicable
hERG inhibition (predictor I)Weak inhibitor0.7403
hERG inhibition (predictor II)Non-inhibitor0.8883
ADMET data is predicted using admetSAR, a free tool for evaluating chemical ADMET properties. (23092397)


Mass Spec (NIST)
Not Available
SpectrumSpectrum TypeSplash Key
Predicted MS/MS Spectrum - 10V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 20V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 40V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 10V, Negative (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 20V, Negative (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 40V, Negative (Annotated)Predicted LC-MS/MSNot Available


This compound belongs to the class of organic compounds known as epoxides. These are compounds containing a cyclic ether with three ring atoms(one oxygen and two carbon atoms).
Organic compounds
Super Class
Organoheterocyclic compounds
Sub Class
Not Available
Direct Parent
Alternative Parents
Oxacyclic compounds / Dialkyl ethers / Organopnictogen compounds / Organochlorides / Monoalkylamines / Hydrocarbon derivatives / Alkyl chlorides
Dialkyl ether / Oxirane / Ether / Oxacycle / Amine / Primary amine / Organooxygen compound / Organonitrogen compound / Organochloride / Organohalogen compound
Molecular Framework
Not Available
External Descriptors
Not Available


Small molecule
Pharmacological action
  1. Cannata-Andia JB, Rodriguez-Garcia M, Roman-Garcia P, Tunon-le Poultel D, Lopez-Hernandez F, Rodriguez-Puyol D: New therapies: calcimimetics, phosphate binders and vitamin D receptor activators. Pediatr Nephrol. 2010 Apr;25(4):609-16. doi: 10.1007/s00467-010-1462-9. Epub 2010 Feb 12. [PubMed:20151157]
  2. Novak JE, Szczech LA: Phosphate binders in chronic kidney disease and end-stage renal disease: a patient-centered approach. Semin Dial. 2009 Jan-Feb;22(1):56-63. doi: 10.1111/j.1525-139X.2008.00514.x. Epub 2008 Oct 16. [PubMed:19000107]
  3. Salusky IB: A new era in phosphate binder therapy: what are the options? Kidney Int Suppl. 2006 Dec;(105):S10-5. [PubMed:17136110]
  4. Schucker JJ, Ward KE: Hyperphosphatemia and phosphate binders. Am J Health Syst Pharm. 2005 Nov 15;62(22):2355-61. [PubMed:16278327]

Drug created on June 13, 2005 07:24 / Updated on March 27, 2020 16:52

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