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Drug ReportsSevelamer
Renagel(sevelamer)
Renagel, Renvela, Tasermity (sevelamer) is a small molecule pharmaceutical. Sevelamer was first approved as Renagel on 1998-10-30. It is used to treat hyperphosphatemia in the USA. It has been approved in Europe to treat hyperphosphatemia and renal dialysis.
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Target
Variants
Financial
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6M
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
therapeuticsD013812
Trade Name
FDA
EMA
Renagel, Renvela (generic drugs available since 2017-06-13)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sevelamer carbonate
Tradename
Company
Number
Date
Products
RENVELASanofiN-022318 RX2009-02-18
2 products, RLD, RS
RENVELASanofiN-022127 RX2007-10-19
1 products, RLD, RS
Sevelamer hydrochloride
Tradename
Company
Number
Date
Products
RENAGELSanofiN-021179 RX2000-07-12
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hyperphosphatemiaHP_0002905D054559—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Sevelamer Carbonate, Renvela, Genzyme
90955092030-12-06DP
Sevelamer Carbonate, Renvela, Sanofi
79854182025-10-27DP
ATC Codes
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AE: Drugs for treatment of hyperkalemia and hyperphosphatemia
— V03AE02: Sevelamer
HCPCS
No data
Clinical
Clinical Trials
92 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic renal insufficiencyD051436—N1818154533
HyperphosphatemiaD054559HP_0002905—25142729
Chronic kidney failureD007676EFO_0003884N18.61381316
Renal dialysisD006435EFO_0010690Z99.2——3115
Secondary hyperparathyroidismD006962EFO_1001173——1—124
ArteriosclerosisD001161EFO_0009086I70———1—1
CalcinosisD002114—————1—1
SmallpoxD012899—B03———1—1
Vascular diseasesD014652EFO_0004264I77———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N19—12—14
DialysisD003956————1—12
HyperparathyroidismD006961EFO_0008506E21.3——1——1
Kidney diseasesD007674EFO_0003086N08——1——1
Peritoneal dialysisD010530————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Insulin resistanceD007333HP_0000855E88.819—2——13
Diabetic nephropathiesD003928EFO_0000401—11———2
Cardiovascular diseasesD002318HP_0001626——1——12
Chronic kidney disease-mineral and bone disorderD012080EFO_1001152N25.0—1———1
HypercholesterolemiaD006937HP_0003124——1———1
Hiv infectionsD015658EFO_0000764B20—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10————33
Type 2 diabetes mellitusD003924EFO_0001360E11————33
Heart failureD006333HP_0001635I50————22
MenorrhagiaD008595EFO_0003945N92.0————22
Hemophilia aD006467EFO_0007267D66————22
PainD010146EFO_0003843R52————22
PneumoniaD011014EFO_0003106—————22
HyperaldosteronismD006929HP_0011736E26————22
Pulmonary arterial hypertensionD000081029——————22
Urinary tract infectionsD014552EFO_0003103N39.0————22
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSevelamer
INNsevelamer
Description
Sevelamer (rINN) is a phosphate binding medication used to treat hyperphosphatemia in patients with chronic kidney disease. When taken with meals, it binds to dietary phosphate and prevents its absorption. Sevelamer was invented and developed by GelTex Pharmaceuticals. Sevelamer is marketed by Sanofi under the brand names Renagel (sevelamer hydrochloride) and Renvela (sevelamer carbonate).
Classification
Small molecule
Drug classpolymers
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C=CCN.ClCC1CO1
Identifiers
PDB—
CAS-ID1392212-84-8
RxCUI—
ChEMBL IDCHEMBL1201798
ChEBI ID—
PubChem CID3085017
DrugBankDB00658
UNII ID941N5DUU5C (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Sevelamer
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,760 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,575 adverse events reported
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