In short
Elinzanetant besilate is an investigational substance studied for vasomotor symptoms, such as hot flashes. One completed Phase 1 trial in 36 healthy volunteers investigated how the body absorbs the drug and how safe it is. The substance is also known under the brand name Lynkuet in the United States, where it is listed for treating hot flashes related to menopause.
Key points
- Elinzanetant besilate is an investigational medicine being studied for vasomotor symptoms such as hot flashes.
- One Phase 1 clinical trial has been completed in 36 healthy subjects.
- The trial compared three different formulations of elinzanetant taken by mouth.
- Researchers measured how much of the drug reaches the blood (bioavailability) after a single dose.
- The substance is also known by the brand name Lynkuet in the United States.
What is elinzanetant besilate?
Elinzanetant besilate is an investigational substance. It is not yet authorised as a medicine in the European Union. The substance is also known by the brand name Lynkuet in the United States, where it is listed as a product containing elinzanetant. In the United States, elinzanetant belongs to the drug class of miscellaneous central nervous system agents. The clinical trial records place the substance in the therapeutic area of hormonal diseases.
How does elinzanetant besilate work?
The sources provided do not describe the exact mechanism of action of elinzanetant besilate. The clinical trial record describes vasomotor symptoms as a sex hormone-dependent disorder in women and men. Elinzanetant is being studied for the treatment of vasomotor symptoms caused by endocrine therapy related to breast cancer, according to a paediatric investigation plan decision.
Which conditions is elinzanetant besilate used or studied for?
- Vasomotor symptoms — hot flashes and similar symptoms related to hormonal changes. The completed trial studied vasomotor symptoms as a sex hormone-dependent disorder in women and men.
- Hot flashes — a common symptom during menopause. In the United States, elinzanetant is listed for the treatment of hot flashes.
- Menopause — the time when menstrual periods stop. Elinzanetant is listed in the United States for use in menopause.
- Vasomotor symptoms caused by endocrine therapy related to breast cancer — a condition for which a paediatric investigation plan waiver was granted because the condition does not occur in children.
How is elinzanetant besilate given?
In the completed clinical trial, elinzanetant besilate was given by mouth in a dose of 120 milligrams. The trial compared three different formulations of the drug, all taken orally.
What do the clinical trials show?
One completed Phase 1 trial investigated elinzanetant besilate in 36 healthy subjects. The trial compared the relative bioavailability of elinzanetant after a single dose taken under fasted conditions. Three different formulations were tested: formulation A versus formulation B, and formulation A versus formulation C. The main measurements were AUC, which is the total amount of the drug in the blood over time, and Cmax, which is the highest concentration of the drug reached in the blood. The trial also looked at how safe the drug is and how it affects the body after single and multiple doses.
What side effects are known?
The sources provided do not contain information about side effects of elinzanetant besilate.