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AboutPricing
Drug ReportsUrsodiol
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
Therapeutic Area
MeSH
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Actigall, Urso, Ursodiol (discontinued: Actigall, Ursodiol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ursodiol
Tradename
Company
Number
Date
Products
URSO 250AllerganN-020675 RX1997-12-10
1 products, RLD
URSO FORTEAllerganN-020675 RX2004-07-21
1 products, RLD, RS
ACTIGALLTevaN-019594 RX1987-12-31
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
festal plusunapproved drug other2018-11-22
reltone 200 mg reltone 400 mgANDA2023-01-16
urso 250 urso forteNew Drug Application2023-01-12
urso urso forte2008-05-27
ursodiolANDA2025-03-13
ursodiol 200 mg ursodiol 400 mgANDA2024-11-26
ursodiol capsulesANDA2010-05-25
urusaunapproved drug other2018-11-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
biliary liver cirrhosis—D008105K74.3
cholelithiasisEFO_0004799D002769K80
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A05: Bile and liver therapy drugs
— A05A: Bile therapy drugs
— A05AA: Bile acids and derivatives for bile therapy
— A05AA02: Ursodeoxycholic acid
HCPCS
No data
Clinical
Clinical Trials
210 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
MalnutritionD044342EFO_0008572E40-E461————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameUrsodiol
INNursodeoxycholic 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—
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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-ID128-13-2
RxCUI—
ChEMBL IDCHEMBL1551
ChEBI ID9907
PubChem CID31401
DrugBankDB01586
UNII ID724L30Y2QR (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Ursodiol
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,651 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,022 adverse events reported
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