PharmaKB logo
Company Reports
Company Reports
Drug Reports
Drug Reports
Disease Reports
Disease Reports
Sets
Sets
Favorites
Favorites
Log in
Log in
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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Plot placeholder
Mock data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Actigall, Ursodiol (discontinued: Actigall, Urso, 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
ACTIGALLTevaN-019594 RX1987-12-31
1 products, RLD, RS
Show 3 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
ursodiolNDA authorized generic2025-08-14
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
219 clinical trials
View more details
Plot placeholder
Mock data
Subscribe for the real data
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
View more details
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—
Image (chem structure or protein)Loading
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)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Plot placeholder
Mock data
Subscribe for the real data
Additional graphs summarizing 10,491 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Plot placeholder
Mock data
Subscribe for the real data
5,293 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use