Welchol, Cholestagel(colesevelam hydrochloride)
Cholestagel, Colesevelam, Welchol (colesevelam hydrochloride) is a small molecule pharmaceutical. Colesevelam hydrochloride was first approved as Welchol on 2000-05-26. It is used to treat coronary artery disease, diarrhea, hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia amongst others in the USA. It has been approved in Europe to treat hypercholesterolemia.
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Commercial
Trade Name
FDA
EMA
Colesevelam, Welchol (discontinued: Colesevelam, Welchol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Colesevelam hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| WELCHOL | Cosette Pharmaceuticals | N-022362 RX | 2009-10-02 | 1 products, RLD, RS |
| WELCHOL | Cosette Pharmaceuticals | N-021176 RX | 2000-05-26 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| colesevelam | ANDA | 2024-08-23 |
| colesevelam hcl | ANDA | 2024-08-22 |
| colesevelam hydrochloride | ANDA | 2024-09-14 |
| welchol | New Drug Application | 2022-09-07 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
COLESEVELAM HYDROCHLORIDE, WELCHOL, COSETTE | |||
| 2024-10-20 | M-232 | ||
Patent Expiration
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HCPCS
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Clinical
Clinical Trials
60 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 3 | 9 | 4 | 3 | 18 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 3 | 6 | 1 | 4 | 13 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | 1 | 1 | 7 | — | 9 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 4 | — | 2 | 1 | 7 |
| Malabsorption syndromes | D008286 | EFO_0009554 | K90 | — | 1 | 1 | 4 | — | 6 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | — | — | 1 | 3 | 1 | 5 |
| Dyslipidemias | D050171 | HP_0003119 | — | — | — | — | 2 | 2 | 4 |
| Hyperlipoproteinemias | D006951 | HP_0010980 | — | — | — | — | 3 | — | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 2 | 1 | 3 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 2 | — | 1 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | 2 | 2 | — | — | 4 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | — | 2 | 2 | — | — | 4 |
| Insulin resistance | D007333 | HP_0000855 | — | — | 1 | 1 | — | 1 | 3 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | 2 | — | 1 | 3 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | 2 | — | — | 2 |
| Fecal incontinence | D005242 | — | R15 | — | — | 1 | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | 1 | 1 | — | — | 1 |
| Pruritus | D011537 | HP_0000989 | L29 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | — | 2 | — | — | — | 2 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | — | — | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Fontan procedure | D018729 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colonic neoplasms | D003110 | — | C18 | — | — | — | — | 1 | 1 |
| Adenocarcinoma | D000230 | — | — | — | — | — | — | 1 | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Colesevelam hydrochloride |
| INN | colesevelam |
| Description | Colesevelam is a bile acid sequestrant administered orally. It was developed by GelTex Pharmaceuticals and later acquired by Genzyme. It is marketed in the U.S. by Daiichi Sankyo under the brand name Welchol and elsewhere by Genzyme as Cholestagel. In Canada it is marketed by Valeant as Lodalis.
|
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 182815-43-6 |
| RxCUI | 141626 |
| ChEMBL ID | CHEMBL1201473 |
| ChEBI ID | — |
| PubChem CID | 160051 |
| DrugBank | DB00930 |
| UNII ID | 1XU104G55N (ChemIDplus, GSRS) |
Target
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Estimated US medical usage
Colesevelam hydrochloride
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Colesevelam
Total medical expenditures per year (USD, in millions)
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Additional graphs summarizing 1,470 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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3,831 adverse events reported
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