Phuturdex › Drugs › Oteracil Potassium
Drugs in development · updated 11 November 2026
Oteracil Potassium: clinical trials and development status
As of 11 November 2026 Oteracil Potassium is in 4 active clinical trials (recruiting or ongoing, phases I–III) for 6 diseases. The most advanced phase is III.
Authorisation
- EU yes, since 14 Mar 2011 (EMA)
- Italy yes (EU authorisation)
- Germany yes (EU authorisation)
- 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
The potassium salt of oxonate, an enzyme inhibitor that modulates 5- fluorouracil (5-FU) toxicity. Potassium oxonate inhibits orotate phosphoribosyltransferase, which catalyzes the conversion of 5-FU to its active or phosphorylated form, FUMP. Upon oral administration, Oxonate is selectively distributed to the intracellular sites of tissues lining the small intestines, producing localized inhibitory effects within the gastrointestinal tract. As a result, 5-FU associated gastrointestinal toxic effects are reduced and the incidence of diarrhea or mucositis is decreased in 5-FU related therapy.
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 |
|---|---|---|---|
| Bile duct neoplasm | III | 1 | NCT06109779 |
| Biliary tract neoplasm | III | 1 | NCT06109779 |
| Cholangiocarcinoma | III | 1 | NCT06109779 |
| Gallbladder neoplasm | III | 1 | NCT06109779 |
| Klatskin's tumor | III | 1 | NCT06109779 |
| Esophageal squamous cell carcinoma | II | 1 | NCT06487702 |
Sites in Europe
50 sites of the active trials in 9 European countries, 0 recruiting.
- Germany15
- France7
- Italy6
- Spain6
- United Kingdom6
- Poland5
- Belgium3
- Denmark1
- and 1 more
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 Oteracil Potassium
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.