Product Description
Ursodeoxycholic acid or ursodiol is a naturally occurring bile acid that is used dissolve cholesterol gall stones and to treat cholestatic forms of liver diseases including primary biliary cirrhosis. Ursodiol has been linked to rare instances of transient and mild serum aminotransferase elevations during therapy and to rare instances of jaundice and worsening of liver disease in patients with preexisting cirrhosis. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Ursodeoxycholic-acid)
Mechanisms of Action: TNF Inhibitor,IL8 Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Vietnam
Approved Indications: Biliary Cirrhosis | Cholangitis
Known Adverse Events: Abdominal Pain | Pain Unspecified | Alopecia | Pruritus | Diarrhea
Company: Daewoong
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, Japan, Korea, Spain
Active Clinical Trial Count: 5
Highest Development Phases
Phase 3: Biliary Cirrhosis|Cholecystolithiasis|Cholelithiasis|Gallstones|Liver Cirrhosis|Pancreatitis, Acute
Phase 1: Bile Reflux|Cholestatic Liver Disease|Gastritis|Healthy Volunteers|Presbyopia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| OSOPOLAR | P3 |
Not yet recruiting |
Cholelithiasis|Cholecystolithiasis|Pancreatitis, Acute|Gallstones |
2025-07-01 |
|
| FDZJ-OCA-202011 | P3 |
Completed |
Biliary Cirrhosis|Liver Cirrhosis |
2023-10-16 |
|
| DW_DWJ1464103 | P1 |
Completed |
Healthy Volunteers |
2023-01-30 |
28% |
| jRCT2031210614 | P1 |
Completed |
Presbyopia |
2022-03-23 |