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
Welchol (generic drugs available since 2018-05-16)
Drug Products
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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-021176 RX | 2000-05-26 | 1 products, RLD, RS |
| WELCHOL | Cosette Pharmaceuticals | N-022362 RX | 2009-10-02 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| colesevelam | ANDA | 2023-09-16 |
| colesevelam hcl | ANDA | 2024-02-02 |
| colesevelam hydrochloride | ANDA | 2024-01-09 |
| 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 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | 1 | 1 | 6 | — | 8 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | — | — | 1 | 2 | 1 | 4 |
| Dyslipidemias | D050171 | HP_0003119 | — | — | — | — | 2 | 2 | 4 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 2 | 1 | 3 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 2 | — | 1 | — | 3 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | 1 | — | 3 |
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | — | — | — | 1 | — | 1 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | 1 | — | 1 |
| Familial combined hyperlipidemia | D006950 | EFO_0000492 | E78.49 | — | — | — | 1 | — | 1 |
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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 |
| Fecal incontinence | D005242 | — | R15 | — | — | 1 | — | — | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 2 | — | — | 1 | 3 |
| Multiple myeloma | D009101 | — | C90.0 | — | 2 | — | — | — | 2 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | — | — | — | — | 1 | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 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) |
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Estimated US medical usage
Colesevelam hydrochloride
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Colesevelam
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Safety
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3,555 adverse events reported
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