Hot flashes — those sudden, often unpredictable waves of heat and sweating — affect millions of women, severely interrupting their sleep, concentration, and overall quality of life, sometimes for years.
But a new era of treatment has just arrived. The FDA has approved Lynkuet (elinzanetant), developed by Bayer, specifically for treating moderate to severe hot flashes caused by menopause.
The approval marks a significant and welcome expansion of non-hormonal options in the vasomotor-symptom space, bringing forward the first and only dual neurokinin (NK) receptor antagonist, targeting both the NK1 and NK3 receptors.
Beyond hormones
Yesmean H. Wahdan, Vice President, US Medical Affairs, Women’s Healthcare at Bayer, told DDN that Lynkuet is “a targeted therapy aimed at addressing the direct underlying triggers of vasomotor symptoms.” She also noted that it “provides healthcare providers with a new treatment option that can be used first-line for moderate to severe hot flashes due to menopause.”
Unlike traditional hormone-based treatments that replace or supplement estrogen/progestin systems, Lynkuet operates through a completely different mechanism: neuronal thermoregulation pathways.
Specifically, it works by inhibiting substance P and neurokinin B signaling. It does this by antagonizing (blocking) the NK1 and NK3 receptors on special nerve cells called kisspeptin/neurokinin B/dynorphin (KNDy) neurons. By doing so, it modulates the neuronal activity tied to temperature control.
Striking while the iron is hot
This approval comes amid a rising global market for menopause-related therapies and hot flash treatment.
The global menopause market was estimated at approximately $17.79 billion in 2024 and is projected to reach around $24.35 billion by 2030, representing a compound annual growth rate (CAGR) of about 5.4 percent. For the specific hot-flash treatment category, one recent analysis pegged the market at approximately $14.14 billion in 2023, projecting to $20.14 billion by 2030.
These figures highlight a sizable and growing addressable market. “The robust placebo-controlled impact seen from the OASIS clinical trials validate KNDy neuron modulation as a targeted treatment strategy," said Wahdan.
Clinical trial design
The approval is supported by robust data from three Phase 3 trials (OASIS 1, OASIS 2 and OASIS 3) that enrolled a combined total of about 1,420 women. In OASIS 1 and OASIS 2 (n=796), Lynkuet met both co-primary endpoints — a significant reduction in the number and severity of moderate to severe hot flashes at weeks four and 12.
Bayer’s three-trial OASIS program ensured the study population encompassed a broad range of symptomatic women. In OASIS 1 and 2, the mean age was 54.6 years (range 40-65). The racial distribution was approximately 80.4 percent White, 17.1 percent Black or African American, and 0.5 percent Asian; about 8.5 percent were Hispanic or Latino. The population included women with prior hysterectomy (38.8 percent), prior oophorectomy (20.6 percent), or prior menopausal hormone therapy use (31.4 percent).
Wahdan commented that this design “invites further data generation regarding potential benefits beyond thermoregulation,” indicating the company sees broader implications of neurokinin-pathway targeting for other women’s neuroendocrine conditions.
What's next
This approval delivers a new non-hormonal option in a space that has long been dominated by hormone replacement therapies while also drawing attention to a historically underserved area of women’s health. Wahdan emphasized, “Women and providers now have treatment options to determine what treatment is best for each woman.”
Given the rising market size and the severity of the symptoms — hot flashes remain among the most common menopause symptoms and one of the main reasons women seek treatment — Lynkuet’s launch may help catalyze a new wave of R&D focus on non-hormonal and neuroendocrine-targeted therapies for mid-life women’s health.
