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 diseases | D009750 |
| therapeutics | D013812 |
Trade Name
FDA
EMA
Renagel, Renvela, Sevelamer (discontinued: Renagel, Sevelamer)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| renagel | New Drug Application | 2018-02-14 |
| renvela | New Drug Application | 2023-09-25 |
| sevelamer carbonate | ANDA | 2024-09-05 |
| sevelamer carbonate for oral suspension | ANDA | 2023-03-24 |
| sevelamer hydrochloride | ANDA | 2024-08-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hyperphosphatemia | HP_0002905 | D054559 | — |
Agency Specific
FDA
EMA
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HCPCS
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Clinical
Clinical Trials
94 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | 3 | 12 | 20 | 5 | 9 | 49 |
| Chronic renal insufficiency | D051436 | — | N18 | 2 | 11 | 20 | 5 | 6 | 44 |
| Hyperphosphatemia | D054559 | HP_0002905 | — | 2 | 8 | 16 | 2 | 7 | 34 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | 1 | 4 | 8 | 1 | 5 | 19 |
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | — | 1 | 1 | 1 | 2 | 5 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | — | 1 | 1 | 1 | 2 | 5 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | 3 | 1 | 1 | 5 |
| Calcinosis | D002114 | — | — | — | — | — | 3 | 1 | 4 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 1 | — | 1 | 2 | 4 |
| Arteriosclerosis | D001161 | EFO_0009086 | I70 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | 4 | 6 | — | 2 | 13 |
| Dialysis | D003956 | — | — | — | — | 1 | — | 1 | 2 |
| Peritoneal dialysis | D010530 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | HP_0000855 | — | — | 2 | — | — | 1 | 3 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | 1 | — | — | — | 2 |
| Chronic kidney disease-mineral and bone disorder | D012080 | EFO_1001152 | N25.0 | — | 1 | — | — | — | 1 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | 1 | — | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
| Endotoxemia | D019446 | — | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 4 | 4 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 3 | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 2 | 2 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 2 | 2 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 2 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 2 | 2 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 2 | 2 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sevelamer |
| INN | sevelamer |
| 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 class | polymers |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=CCN.ClCC1CO1 |
Identifiers
| PDB | — |
| CAS-ID | 1392212-84-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201798 |
| ChEBI ID | — |
| PubChem CID | 3085017 |
| DrugBank | DB00658 |
| UNII ID | 941N5DUU5C (ChemIDplus, GSRS) |
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Estimated US medical usage
Sevelamer
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 2,843 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,955 adverse events reported
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