In short
Denatonium benzoate is a chemical substance known for its intensely bitter taste. It is not a medicine but is used in clinical research, for example in a completed Phase 1 trial with 12 healthy adults to assess the taste of an oral suspension of the investigational drug sisunatovir for RSV. In that trial, denatonium benzoate served as an auxiliary substance to help evaluate palatability.
Key points
- Denatonium benzoate is a chemically synthesised substance classified as an auxiliary agent in one registered clinical trial.
- The only clinical trial in the registry is a Phase 1 study completed in healthy adults.
- The trial enrolled 12 participants and tested the taste of an oral suspension containing the investigational drug sisunatovir.
- The studied condition was RSV (respiratory syncytial virus), although the trial did not treat patients with RSV.
- The main outcome was a palatability questionnaire covering bitterness, sweetness, mouth feel and overall liking.
- Denatonium benzoate has no marketing authorisation and is not an approved medicine in the product records.
What is denatonium benzoate?
Denatonium benzoate is a chemically synthesised substance known for its extremely bitter taste. In the EU Clinical Trials Information System product records, it is listed under the therapeutic area of virus diseases and is described as an investigational substance with no marketing authorisation. The company named in the product record is Pfizer Inc.
Denatonium benzoate is also known by its chemical name benzyl-[2-(2,6-dimethylanilino)-2-oxoethyl]-diethylazanium benzoate and by the development code WIN-16568. It is not an approved medicine for treating any disease.
How does denatonium benzoate work?
Denatonium benzoate is a bitter taste receptor agonist. This means it activates bitter taste receptors, known as TAS2Rs, which are G protein-coupled receptors that normally signal the presence of potentially harmful substances in the mouth. Research has also shown that these receptors are present on some cancer cells, including acute myeloid leukaemia cells, where their activation can change gene expression and cell functions. In the registered clinical trial, denatonium benzoate was used for its bitter taste to help evaluate the palatability of another medicine.
Which conditions is it used or studied for?
- RSV (respiratory syncytial virus): The only registered trial involving denatonium benzoate is listed under RSV, a common respiratory virus. However, the trial did not treat RSV; it tested the taste of an oral suspension of sisunatovir, an investigational medicine for RSV, in healthy adults.
- Acute myeloid leukaemia: Laboratory research has studied denatonium as a bitter taste receptor agonist in acute myeloid leukaemia cells, where it modified their transcriptomic profile and functions. This research was done in cells, not in patients.
How is denatonium benzoate given?
In the registered clinical trial, denatonium benzoate was used as an oral solution at a very small amount of 2 micrograms, taken by mouth. The product record lists the pharmaceutical form as oral solution and the route of administration as oral.
What do the clinical trials show?
There is one registered clinical trial involving denatonium benzoate. It is a Phase 1 study that has been completed. The trial enrolled 12 healthy adult participants and was designed to assess the palatability attributes of sisunatovir in different formulations. Denatonium benzoate was used as an auxiliary substance in this trial, meaning it supported the study rather than being the medicine under investigation.
The primary outcome was a palatability assessment questionnaire covering mouth feel, bitterness, sweetness, sourness, saltiness, tongue or mouth burn, and overall liking. The trial did not measure whether denatonium benzoate treats any disease.
What side effects are known?
The provided sources do not report any side effects for denatonium benzoate. The registered trial did not list side effect outcomes, and the supplementary sources describe its chemical identity and laboratory effects on cancer cells rather than side effects in people.