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Elinzanetant: First Approval.

¹Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

|November 12, 2025

Summary

This summary is machine-generated.

Elinzanetant is a new non-hormonal treatment approved for vasomotor symptoms (VMS) associated with menopause. This neurokinin-targeted therapy effectively reduces VMS frequency and severity, marking a significant advancement in women's health.

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Area of Science:

Pharmacology
Neuroscience
Women's Health

Background:

Vasomotor symptoms (VMS), such as hot flashes and night sweats, significantly impact women's quality of life during menopause.
Current treatments for VMS often involve hormone replacement therapy, which carries potential risks and is not suitable for all individuals.
There is a need for safe and effective non-hormonal therapies to manage moderate to severe VMS.

Purpose of the Study:

To summarize the development milestones of elinzanetant, a novel non-hormonal therapy for VMS.
To highlight the mechanism of action of elinzanetant as a neurokinin-1 (NK₁) and neurokinin-3 (NK₃) antagonist.
To present the clinical evidence supporting elinzanetant's efficacy in reducing VMS frequency and severity.

Main Methods:

Development of elinzanetant as a small-molecule, non-hormonal antagonist targeting NK₁ and NK₃ receptors.
Clinical trials, including the OASIS studies, were conducted to evaluate the safety and efficacy of elinzanetant for VMS.
Analysis of clinical trial data to demonstrate the reduction in VMS frequency and severity.

Main Results:

Elinzanetant demonstrated significant reduction in the frequency and severity of moderate to severe VMS associated with menopause.
The neurokinin-targeted therapy modulates the activity of hyperactive kisspeptin/neurokinin B/dynorphin neurones.
The OASIS clinical trials provided robust evidence for elinzanetant's efficacy.

Conclusions:

Elinzanetant represents a significant advancement in the treatment of VMS, offering a non-hormonal therapeutic option.
The drug's approval marks a milestone in addressing the unmet needs of women experiencing moderate to severe VMS.
Elinzanetant's mechanism of action provides a novel approach to managing menopausal symptoms.