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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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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
Brand Name
Status
Last Update
renagelNew Drug Application2020-04-30
renvelaNew Drug Application2021-07-15
sevelamer hydrochlorideANDA2023-06-05
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
83 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 insufficiencyD051436N1818154331
HyperphosphatemiaD054559HP_000290523122524
Chronic kidney failureD007676EFO_0003884N18.61371214
Renal dialysisD006435EFO_0010690Z99.23115
Secondary hyperparathyroidismD006962EFO_10011731124
ArteriosclerosisD001161EFO_0009086I7011
CalcinosisD00211411
Vascular diseasesD014652EFO_0004264I7711
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N191214
DialysisD003956112
HyperparathyroidismD006961EFO_0008506E21.311
Kidney diseasesD007674EFO_0003086N0811
Peritoneal dialysisD01053011
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Insulin resistanceD007333EFO_0002614213
Diabetic nephropathiesD003928EFO_0000401112
Cardiovascular diseasesD002318EFO_0000319I98112
Chronic kidney disease-mineral and bone disorderD012080EFO_1001152N25.011
HypercholesterolemiaD006937HP_000312411
Hiv infectionsD015658EFO_0000764B2011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients44
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 2 diabetes mellitusD003924EFO_0001360E1133
ObesityD009765EFO_0001073E66.911
HypertensionD006973EFO_0000537I1011
InflammationD00724911
AtherosclerosisD050197EFO_0003914I25.111
Familial hypophosphatemiaD007015E83.3111
RicketsD012279EFO_0005583E55.011
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)
Structure (InChI/SMILES or Protein Sequence)
C=CCN.ClCC1CO1
Identifiers
PDB
CAS-ID52757-95-6
RxCUI214824
ChEMBL IDCHEMBL1201798
ChEBI ID
PubChem CID3085017
DrugBankDB00658
UNII ID941N5DUU5C (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,526 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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444 adverse events reported
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