In short
Unesbulin is an investigational substance being studied in oncology for patients with advanced solid tumors. The clinical research available consists of one completed Phase 1 trial that enrolled 12 participants. The trial investigated how the body absorbs, breaks down, and eliminates unesbulin after oral and intravenous administration.
Key points
- Unesbulin is an investigational substance with no marketing authorisation in these records.
- The only registered trial is a Phase 1 study in patients with advanced solid tumors.
- The trial enrolled 12 participants and is now completed.
- The study measured pharmacokinetics — how the drug moves through and leaves the body.
- Unesbulin was given both orally and intravenously in the trial.
What is unesbulin?
Unesbulin is an investigational substance studied in oncology, specifically in the therapeutic area of neoplasms (cancers). No marketing authorisation is recorded for unesbulin in the available trial records, meaning it is not yet an authorised medicine. The trial data do not provide a trade name or development code for unesbulin.
How does unesbulin work?
The available trial records do not describe the mechanism of action of unesbulin. The Phase 1 study focused on how the body processes the substance — its absorption, distribution, metabolism, and excretion — rather than on how it acts against cancer cells. No molecular target is stated in the provided data.
Which conditions is unesbulin studied for?
- Advanced solid tumors — the trial enrolled patients with solid tumors, which are cancers that form lumps in organs or tissues rather than in the blood or bone marrow.
How is unesbulin given?
In the completed trial, unesbulin was given by two routes: as a 300 mg oral dose and as a 100 µg intravenous dose. The oral form was used in three parts of the study, while the intravenous form was used to measure absolute oral bioavailability — the proportion of an oral dose that reaches the bloodstream compared with an intravenous dose.
What do the clinical trials show?
One completed Phase 1 trial investigated unesbulin in 12 participants with advanced solid tumors. The study had three parts and used a radiolabelled form of the drug (14C-unesbulin) to trace how the substance is absorbed, metabolised, and excreted. The primary outcomes measured included plasma pharmacokinetic parameters such as the area under the plasma concentration-time curve (AUC), maximum plasma concentration (Cmax), time to maximum concentration (Tmax), and elimination half-life (T1/2). The trial also measured how much radioactivity was excreted in urine and feces, and identified metabolites of unesbulin in plasma, urine, and feces. The status of the trial is completed, meaning the study has finished.
What side effects are known?
No information on side effects is available in the provided sources.