Phuturdex › Drugs › Ursodeoxycholic Acid
Drugs in development · updated 11 November 2026
Ursodeoxycholic Acid: clinical trials and development status
Other names and codes: UDCA, Ursodiol
As of 11 November 2026 Ursodeoxycholic Acid is in 13 active clinical trials (recruiting or ongoing, phases I–III) for 12 diseases. The most advanced phase is III.
Authorisation
- EU no (EMA)
- Italy not in the AIFA register
- Germany not available
- US no (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is
A synthetically-derived form of ursodiol, a bile acid produced by the liver and secreted and stored in the gallbladder. Also produced by the Chinese black bear liver, ursodiol has been used in the treatment of liver disease for centuries. This agent dissolves or prevents cholesterol gallstones by blocking hepatic cholesterol production and decreasing bile cholesterol. Ursodiol also reduces the absorption of cholesterol from the intestinal tract.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Liver Cirrhosis, Biliary | III | 6 | NCT02823366 |
| Gallstones | III | 1 | NCT04924868 |
| Pancreatitis | III | 1 | NCT04924868 |
| Sepsis | II–III | 1 | NCT07852780 |
| Acute kidney injury | II | 1 | NCT07672860 |
| Bladder neoplasm | II | 1 | NCT07717242 |
| Breast neoplasm | II | 1 | NCT06842472 |
| Kidney neoplasm | II | 1 | NCT07672860 |
| Neoplasm | II | 1 | NCT07378761 |
| Reperfusion injury | II | 1 | NCT07672860 |
| Transitional cell carcinoma | II | 1 | NCT07717242 |
| Clostridium Infections | Early I | 1 | NCT06884748 |
Sites in Europe
24 sites of the active trials in 2 European countries, 11 recruiting.
- Spain18
- France6
Sites declared by the sponsors on ClinicalTrials.gov; region worked out by Phuturdex from the geographic point. The list of sites with city and recruitment status is in the app. See the sites →
Everything on Ursodeoxycholic Acid
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 11 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.