Ursodiol
Actigall, Urso (ursodiol) is a small molecule pharmaceutical. Ursodiol was first approved as Actigall on 1987-12-31. It is used to treat biliary liver cirrhosis and cholelithiasis in the USA.
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Trade Name
FDA
EMA
Actigall, Urso (generic drugs available since 2000-03-14)
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 |
|---|---|---|
| ursodiol | ANDA | 2023-06-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| biliary liver cirrhosis | — | D008105 | K74.3 |
| cholelithiasis | EFO_0004799 | D002769 | K80 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | EFO_0000545 | 1 | 3 | 4 | 3 | 4 | 14 | |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | 3 | 1 | 1 | 6 |
| Kallmann syndrome | D017436 | Orphanet_478 | E23.0 | — | — | — | 1 | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fertility | D005298 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | URSODIOL |
| INN | ursodeoxycholic acid |
| Description | Ursodeoxycholic acid is a bile acid found in the bile of bears (Ursidae) as a conjugate with taurine. Used therapeutically, it prevents the synthesis and absorption of cholesterol and can lead to the dissolution of gallstones. It has a role as a human metabolite and a mouse metabolite. It is a bile acid, a dihydroxy-5beta-cholanic acid and a C24-steroid. It is a conjugate acid of an ursodeoxycholate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H](CCC(=O)O)[C@H]1CC[C@H]2[C@@H]3[C@@H](O)C[C@@H]4C[C@H](O)CC[C@]4(C)[C@H]3CC[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 128-13-2 |
| RxCUI | 11065 |
| ChEMBL ID | CHEMBL1551 |
| ChEBI ID | 9907 |
| PubChem CID | 31401 |
| DrugBank | DB01586 |
| UNII ID | 724L30Y2QR (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,003 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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169 adverse events reported
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