New Nonhormonal Treatment Offers Relief for Women Experiencing Vasomotor Symptoms During Menopause

This content was independently produced by Pharmacy Times in partnership with Bayer Healthcare.

Data suggest up to 80% and 60% of women experience hot flashes and sleep disturbances, respectively, during menopausal transition. These vasomotor symptoms (VMS) can significantly reduce quality of life, impact daily functioning, and affect work productivity. Additionally, menopausal symptoms have been linked to long-term health risks, including cardiovascular events, depression, cognitive decline, and other adverse brain outcomes.¹

Perimenopause typically begins in women around 40 years of age, and menopause usually progresses between the ages of 45 and 58 years, with an average age of onset of 52 years. Women can experience hot flashes, night sweats, heart palpitations, and changes in blood pressure and temperature during this period. Notably, up to 75% of women in the US experience hot flashes that occur over a span of 6 months to 2 years, but some women can have them for up to 10 years. Additionally, hot flashes can occur in the perimenopause stage or may begin after the final menstrual period, caused by hormonal shifts that impact the biological processes that manage blood pressure and temperature.²

Several treatment options are available for managing menopausal symptoms. Hormone therapy and low-dose paroxetine (7.5 mg) are approved in some countries for the management of VMS, and selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) are sometimes used off-label. However, many women cannot use these therapies due to contradictions, experience adverse effects that lead to discontinuation, or prefer to avoid them.¹

A Nonhormonal Treatment Option for Menopause

The newly approved elinzanetant (Lynkuet; Bayer) could offer nonhormonal relief for women who experience VMS symptoms. It is the first neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist approved for the hormone-free treatment of moderate to severe VMS due to menopause.^3,4

Dual inhibition of these receptors is believed to reduce VMS and improve sleep disturbances linked to menopause. Blocking substance P and neurokinin B through NK1 and NK3 receptor antagonism affects kisspeptin/neurokinin B/dynorphin neurons, helping regulate the neuronal activity involved in thermoregulation and reducing hot flashes.⁴

Elinzanetant 60-mg capsules received FDA approval in October 2025 for the treatment of moderate to severe hot flashes due to menopause. The soft gel capsules should be taken once daily at bedtime, with or without food, to provide relief for women experiencing VMS and menopause-related sleep disturbances.⁴

“The FDA approval of [elinzanetant] is an important new option for women and providers who are treating moderate to severe hot flashes due to menopause,” Yesmean H. Wahdan, MD, senior vice president and head of medical affairs USA & North America at Bayer, said in a news release.⁴

The approval of elinzanetant is based on data from 3 phase 3 clinical trials: OASIS 1 (NCT05042362), OASIS 2 (NCT05099159), and OASIS 3 (NCT05030584), which evaluated the safety and efficacy of the nonhormonal treatment for moderate to severe hot flashes caused by menopause.^4-7 In the double-blind, randomized, placebo-controlled multicenter OASIS 1 and 2 clinical trials, 396 and 400 postmenopausal women aged 40 to 65 years were included and randomly assigned to receive elinzanetant or placebo. Across 26 weeks, patients in the elinzanetant group received a 120-mg dose once daily, and patients in the control arm received a matching placebo dose once daily for 12 weeks, followed by 120 mg of elinzanetant for 14 weeks.⁴

In the double-blind, randomized, placebo-controlled multicenter OASIS 3 clinical trial, 627 postmenopausal women aged 40 to 65 years across 9 countries were randomly assigned to receive 120 mg of elinzanetant over 52 weeks.⁴

“These studies investigated the safety and efficacy of elinzanetant for the treatment of moderate to severe hot flashes due to menopause,” JoAnn V. Pinkerton, MD, professor and director of Midlife Health at UVA Health and lead investigator on the OASIS 2 trial, said in a news release.⁴ “Hot flashes, particularly when severe, can have an impact on women’s daily lives, and this approval provides health care providers with a new treatment option that can be used in the first line for moderate to severe hot flashes due to menopause.”

In OASIS 1 and 2, the primary end points were changes in frequency and severity of moderate to severe VMS at weeks 4 and 12; secondary end points assessed sleep quality and menopause-related quality of life. Elinzanetant significantly reduced VMS frequency and severity at both weeks 4 and 12 compared with placebo and improved sleep disturbances and quality of life, with a favorable safety profile.¹

In OASIS 3, elinzanetant significantly reduced the frequency of moderate to severe VMS at week 12 compared with placebo, and also improved sleep and menopause-related quality of life. Average daily VMS decreased from approximately 7 to 1.6 with elinzanetant compared with 3.4 with placebo; benefits were maintained through 52 weeks.^1,2

“To see the tolerability of elinzanetant in OASIS 3 remain consistent with earlier studies is very promising. With a longer study duration and in a population with a VMS profile potentially more representative of that seen in clinical practice suggests, if approved, elinzanetant may be another option for women [with] moderate to severe VMS,” James A. Simon, MD, clinical professor of obstetrics and gynecology at The George Washington University School of Medicine in Washington, DC, and founder of IntimMedicine Specialists, said in a news release.⁸

What Should Pharmacists Know?

The approval of elinzanetant marks a significant advancement in menopause care, offering women an effective nonhormonal option for managing moderate to severe VMS and related sleep disturbances. Unlike hormone therapy, which may not be tolerable or preferred for many women due to contraindications or adverse effects, elinzanetant provides a targeted, hormone-free approach that addresses neurochemical pathways involved in hot flashes. This development expands treatment choices and represents meaningful progress in improving quality of life for women navigating the menopausal transition.

“It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause, and today’s approval further expands a woman’s options for treating these symptoms,” Claire Gill, president and founder of the National Menopause Foundation, said in a news release.⁴

REFERENCES

1. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354. doi:10.1001/jama.2024.14618

2. The vasomotor symptoms of menopause. Healthline. Updated October 4, 2023. Accessed October 27, 2025. https://www.healthline.com/health/menopause/vasomotor-symptoms-of-menopause#symptoms

3. Bayer provides regulatory update on elinzanetant for the treatment of moderate to severe hot flashes due to menopause. News release. Bayer. July 25, 2025. Accessed October 27, 2025. https://www.bayer.com/en/us/news-stories/regulatory-update-on-elinzanetant

4. Bayer’s Lynkuet (elinzanetant), the first and only neurokinin 1 and neurokinin 3 receptor antagonist, receives FDA approval for moderate to severe hot flashes due to menopause. News release. Bayer. October 24, 2025. Accessed October 27, 2025. https://www.bayer.com/en/us/news-stories/lynkuet

5. A study to learn more about how well elinzanetant works and how safe it is for the treatment of vasomotor symptoms (hot flashes) that are caused by hormonal changes over 26 weeks in women who have been through the menopause (OASIS-1). Clinicaltrials.gov. Updated June 27, 2024. Accessed October 27, 2025. https://clinicaltrials.gov/study/NCT05042362

6. A study to learn more about how well elinzanetant works and how safe it is for the treatment of vasomotor symptoms (hot flashes) that are caused by hormonal changes over 26 weeks in women who have been through the menopause (OASIS-2). Clinicaltrials.gov. Updated May 29, 2024. Accessed October 27, 2025. https://clinicaltrials.gov/study/NCT05099159

7. A study to learn more about how well elinzanetant works and how safe it is for the treatment of vasomotor symptoms (hot flashes) that are caused by hormonal changes over 52 weeks in women who have been through the menopause (OASIS-3). Clinicaltrials.gov. Updated March 15, 2024. Accessed October 27, 2025. https://clinicaltrials.gov/study/NCT05030584

8. Data from phase III study OASIS 3 support efficacy and long-term safety of investigational compound elinzanetant in the treatment of moderate to severe vasomotor symptoms associated with menopause. News release. Bayer. September 10, 2024. Accessed October 27, 2025. https://www.bayer.com/en/us/news-stories/phase-iii-study-oasis-3