New Hope for Menopause Relief: FDA Approves Elinzanetant, a Non-Hormonal Treatment for Hot Flashes
(published October 26, 2025)
For millions of women navigating the challenges of menopause, a new treatment option offers meaningful promise. The FDA has recently approved elinzanetant (Lynkuet; Bayer), the first dual neurokinin 1 and neurokinin 3 receptor antagonist, specifically for the treatment of moderate to severe hot flashes associated with menopause. This approval builds on the momentum started by fezolinetant (Veozah; Astellas), approved in 2023, which targets the neurokinin 3 receptor and provides a hormone-free approach to managing vasomotor symptoms (VMS) – commonly known as hot flashes and night sweats.1
[Image of menopause word writen on wood block. menopause text on table, concept. | Image Credit: loran4a | stock.adobe.com – positioned right]
This landmark decision provides a crucial, non-hormonal alternative for women seeking relief from disruptive VMS. It also introduces a novel therapeutic class that directly addresses the underlying neurobiological mechanisms driving these symptoms – the neurokinin (NK) pathway.1 For women who are unable or prefer not to use hormone therapy, elinzanetant represents a significant step forward in personalized menopause care.
How Does Elinzanetant Work?
Elinzanetant distinguishes itself through its unique mechanism of action. As a dual NK1/NK3 receptor antagonist, it works within the brain’s thermoregulatory center to restore the delicate temperature balance ofen disrupted during menopause.1 Unlike customary hormone therapies, this approach doesn’t involve introducing hormones into the body, offering a different pathway to symptom control.
Robust Clinical Trial Data Supports Approval
The FDA’s approval was based on compelling data from three pivotal Phase 3 clinical trials: OASIS 1 (NCT05042362), OASIS 2 (NCT05099159), and OASIS 3 (NCT05030584). These trials collectively demonstrated that elinzanetant delivers both significant and sustained reductions in the frequency and severity of hot flashes. Importantly, the trials also showed improvements in sleep quality and overall menopause-related quality of life.2-4
Specifically, data from OASIS 1 and OASIS 2 revealed a statistically significant decrease in VMS frequency with elinzanetant compared to placebo, observed as early as week 4 and maintained through week 12. Furthermore, participants experienced improvements in VMS severity, sleep disturbances, and overall health-related quality-of-life scores by week 12. These benefits were achieved with a favorable safety and tolerability profile.2,4
The long-term efficacy and safety of elinzanetant were further reinforced by the findings from OASIS 3,presented at the 2024 annual meeting of The Menopause Society. This trial demonstrated durable results over a
