What is the promising menopause drug in development?

Oct 10, 2025 3 min read •

women's health Menopause Pharmaceuticals

By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, many of whom struggle with debilitating hot flashes. While traditional hormone replacement therapy is not suitable for everyone, recent advances have produced exciting non-hormonal options, including what is the promising menopause drug, elinzanetant.

Quick Summary

Elinzanetant is a promising dual neurokinin-1 and 3 receptor antagonist being developed by Bayer to treat moderate-to-severe hot flashes, night sweats, and sleep disturbances caused by menopause. Clinical trial results show significant relief for those seeking a non-hormonal solution.

Key Points

Elinzanetant is the most promising drug: This investigational drug from Bayer is a dual neurokinin antagonist that effectively reduces hot flashes and night sweats, with potential benefits for sleep and mood [1].
Fezolinetant (Veozah) is already approved: This is another non-hormonal option that specifically targets the NK-3 receptor to relieve hot flashes [1, 3].
Mechanism targets the brain: Both new drug classes work by modulating specific neurons in the hypothalamus that control body temperature, offering an alternative to hormone therapy [1].
Clinical trials show positive results: Elinzanetant's OASIS Phase 3 trials demonstrated sustained reductions in hot flashes and improvements in quality of life [1, 2].
Non-hormonal options are expanding: Beyond these drugs, personalized care, tech-enabled tracking, and lifestyle adjustments are becoming more central to menopause management [1].
Important for certain populations: These non-hormonal options are especially valuable for women with a history of breast cancer or other conditions that contraindicate hormone therapy [1].

The Shift to Non-Hormonal Menopause Therapies

Concerns about potential health risks associated with hormone replacement therapy (HRT) have led to a demand for non-hormonal treatments for menopausal symptoms like hot flashes and night sweats. This has spurred research into therapies that target the underlying causes of symptoms without using external hormones [1, 4]. These new treatments focus on specific neurochemical pathways in the brain that become overly active during menopause.

Introducing Elinzanetant: A Dual-Action Neurokinin Antagonist

Elinzanetant is considered a highly promising menopause drug currently in late-stage development [1, 4]. It is a dual neurokinin-1 and 3 (NK-1 and NK-3) receptor antagonist [1, 2]. This means it works by blocking signals from both NK-1 and NK-3 receptors on KNDy neurons in the hypothalamus, the part of the brain that regulates body temperature [1]. During menopause, declining estrogen can over-activate these neurons, leading to hot flashes and night sweats. By blocking these receptors, elinzanetant helps to calm this overactive pathway [1]. This dual-action approach may offer broader benefits compared to drugs that target only one receptor [1].

Phase 3 clinical trials, known as the OASIS studies, have shown positive results for elinzanetant:

Significant reductions in the frequency and severity of moderate to severe hot flashes [1, 2].
Rapid symptom improvement for many participants [1, 2].
Improvements in sleep disturbances and overall quality of life [1].
A favorable safety profile, with common side effects being headache and fatigue [1].

Bayer has submitted a New Drug Application for elinzanetant, positioning it as a potential non-hormonal treatment option, particularly for women who cannot use hormone therapy, such as those with a history of breast cancer [1].

Fezolinetant (Veozah): The Approved Predecessor

Fezolinetant (Veozah) was the first neurokinin antagonist to be FDA-approved for treating moderate-to-severe menopausal hot flashes in 2023 [3]. Fezolinetant specifically targets and blocks the NK-3 receptor [1]. While effective in reducing hot flashes, its mechanism differs from elinzanetant's dual action [1].

Comparing the Non-Hormonal Options

Here is a comparison of elinzanetant and fezolinetant:


Feature	Elinzanetant (Bayer)	Fezolinetant (Veozah)
Mechanism of Action	Dual NK-1 and NK-3 receptor antagonist [1]	Selective NK-3 receptor antagonist [1]
Status	Awaiting FDA approval [1]	FDA approved (May 2023) [3]
Symptom Targets	Hot flashes, night sweats, sleep disturbances [1]	Hot flashes (VMS) [1]
Additional Benefits	Trials suggest benefits for sleep and mood [1]	Focused primarily on VMS reduction [1]
Side Effects	Headache, fatigue; generally mild in trials [1]	Headache, fatigue, abdominal pain, diarrhea; requires periodic liver enzyme monitoring [1]
Access & Cost	Currently unavailable; future cost is unknown [1, 5]	Currently available, often requires prior authorization; significant costs without insurance [1, 5]

The Future of Menopause Treatment

The development of non-hormonal therapies like elinzanetant and fezolinetant signifies progress in menopause care [1]. The field is also exploring personalized care, including digital health tools to track symptoms [1]. Research into other compounds continues, pointing towards a future with more tailored management options [1].

Non-Drug Alternatives and Adjunctive Therapies

Lifestyle adjustments, cognitive behavioral therapy (CBT), exercise, and relaxation techniques can also be effective in managing menopausal symptoms [1]. Some older prescription medications like certain SSRIs or gabapentin can also help [1].

In conclusion, while fezolinetant is an approved non-hormonal option, elinzanetant is a strong contender for what is the promising menopause drug due to its potential for broader symptom relief [1]. The focus on non-hormonal and holistic approaches means women will likely have more options for managing menopause and healthy aging [1].

For more information on menopause and its management, consult authoritative sources like Mayo Clinic's Guide to Menopause.

Frequently Asked Questions

The most promising menopause drug currently under review by the FDA is elinzanetant, a dual neurokinin antagonist developed by Bayer [1]. It has shown significant efficacy in Phase 3 trials for treating moderate-to-severe hot flashes, night sweats, and sleep disturbances [1, 2].

Elinzanetant works by blocking two types of neurokinin receptors, NK-1 and NK-3, in the brain's thermoregulatory center [1]. This modulates the activity of neurons that become overactive due to declining estrogen, calming the signals that cause hot flashes and other vasomotor symptoms [1].

While both are non-hormonal neurokinin antagonists, elinzanetant targets two receptors (NK-1 and NK-3), whereas fezolinetant (Veozah) is selective for the NK-3 receptor [1]. This dual action may give elinzanetant a broader benefit profile, including potential effects on sleep and mood [1].

The Phase 3 OASIS clinical trials for elinzanetant demonstrated a rapid and significant reduction in the frequency and severity of hot flashes [1, 2]. Trial participants also reported improvements in sleep and overall quality of life, with a favorable safety profile [1].

These non-hormonal options are particularly suitable for women experiencing moderate-to-severe vasomotor symptoms who cannot or choose not to use hormone replacement therapy [1]. This includes women with a history of breast cancer or other health conditions [1].

Based on clinical trials, the most commonly reported side effects for elinzanetant were mild and included headache, fatigue, and sleepiness [1]. Importantly, trials did not find harmful effects on the liver or bone density [1].

Yes, non-drug options like lifestyle changes, cognitive behavioral therapy (CBT), regular exercise, and stress reduction techniques are very effective for managing menopause symptoms [1]. For many, these approaches are foundational to comprehensive symptom management [1].

References

Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice. Always consult a qualified healthcare provider regarding personal health decisions.