Ursodiol
Actigall, Urso, Ursodiol (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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Commercial
Therapeutic Areas
Trade Name
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Actigall, Urso (generic drugs available since 2000-03-14)
Drug Products
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| biliary liver cirrhosis | — | D008105 | K74.3 |
| cholelithiasis | EFO_0004799 | D002769 | K80 |
Agency Specific
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Clinical
Clinical Trials
174 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biliary liver cirrhosis | D008105 | — | K74.3 | 2 | 19 | 16 | 7 | 7 | 50 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | 2 | 1 | 5 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | — | 2 | 2 | 5 |
| Autoimmune hepatitis | D019693 | — | K75.4 | — | — | — | 2 | 2 | 4 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | 1 | — | 1 | 1 | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | 1 | 2 |
| Gestational diabetes | D016640 | HP_0009800 | O24.4 | — | — | 1 | 1 | — | 2 |
| Cholelithiasis | D002769 | EFO_0004799 | K80 | — | — | 1 | 1 | — | 2 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | 2 | — | 2 |
| Gallstones | D042882 | EFO_0004210 | — | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cholestasis | D002779 | HP_0001396 | K83.1 | — | 3 | 3 | — | 4 | 9 |
| Healthy volunteers/patients | — | — | — | 6 | — | 1 | — | 1 | 8 |
| Sclerosing cholangitis | D015209 | EFO_0004268 | K83.01 | 3 | 3 | 2 | — | — | 6 |
| Intrahepatic cholestasis | D002780 | — | — | — | 2 | 2 | — | — | 3 |
| Adenomatous polyposis coli | D011125 | — | D13.91 | — | 2 | 2 | — | — | 2 |
| Duodenal neoplasms | D004379 | — | — | — | 1 | 1 | — | — | 1 |
| Pregnancy complications | D011248 | — | — | — | 1 | 1 | — | — | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | — | 1 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | 1 | 1 | — | — | 1 |
| Child nutrition disorders | D015362 | — | — | — | 1 | 1 | — | — | 1 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | 4 | — | — | 1 | 5 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 2 | — | — | 2 | 4 |
| Colorectal neoplasms | D015179 | — | — | 1 | 2 | — | — | — | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 2 | 1 | — | — | 1 | 3 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | — | 1 | — | — | 2 | 3 |
| Chronic chemical and drug induced liver injury | D056487 | EFO_1000905 | — | 2 | 2 | — | — | — | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 2 | — | — | — | 2 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 1 | — | — | — | 2 |
| Digestive system diseases | D004066 | HP_0011024 | K92.9 | 1 | 2 | — | — | — | 2 |
| Fibrosis | D005355 | — | — | 1 | 2 | — | — | — | 2 |
Show 16 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overweight | D050177 | — | E66.3 | 1 | — | — | — | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | 1 | — | — | — | — | 1 |
| Huntington disease | D006816 | Orphanet_399 | G10 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 2 | 2 |
| Zellweger syndrome | D015211 | Orphanet_912 | E71.510 | — | — | — | — | 1 | 1 |
| Infantile refsum disease | D052919 | Orphanet_772 | G60.1 | — | — | — | — | 1 | 1 |
| Adrenoleukodystrophy | D000326 | Orphanet_43 | E71.52 | — | — | — | — | 1 | 1 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | — | — | — | 1 | 1 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | — | — | — | — | 1 | 1 |
| Familial amyloid neuropathies | D028227 | — | E85.1 | — | — | — | — | 1 | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | — | — | 1 | 1 |
| Sarcoma | D012509 | — | — | — | — | — | — | 1 | 1 |
| Germ cell and embryonal neoplasms | D009373 | — | — | — | — | — | — | 1 | 1 |
Show 19 more
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 | — |
| ChEMBL ID | CHEMBL1551 |
| ChEBI ID | 9907 |
| PubChem CID | 31401 |
| DrugBank | DB01586 |
| UNII ID | 724L30Y2QR (ChemIDplus, GSRS) |
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Ursodiol
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Safety
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2,886 adverse events reported
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