Elinzanetant Gets UK Nod for Moderate to Severe Vasomotor Symptoms in Menopause: Is the US Far Behind?

July 11, 2025

Bayer's elinzanetant gains UK approval as the first nonhormonal treatment for menopausal symptoms, offering hope to millions of untreated women.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted the first global marketing authorization for elinzanetant, a dual neurokinin-1 and neurokinin-3 receptor antagonist, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, Bayer announced July 10, 2025.1

The drug will be marketed under the brand name Lynkuet™ in the UK. The US FDA set a Prescription Drug User Fee Act date for July 26, 2026, after accepting Bayer's New Drug Application in October 2024.2

Elinzanetant is the first nonhormonal therapy in its class to receive regulatory approval for menopausal VMS, which affects up to 80% of women during the menopausal transition. Despite the high prevalence, nearly two-thirds of symptomatic women remain untreated, according to Bayer.1

The UK approval is based on results from Bayer’s Phase III OASIS clinical development program, comprising 3 pivotal studies (OASIS-1, -2, and -3). Across all 3 trials, elinzanetant met primary efficacy endpoints and showed a favorable safety profile.1

OASIS-1 and OASIS-23:

Elinzanetant significantly reduced the mean frequency and severity of moderate to severe VMS at weeks 4 and 12 compared with placebo.
At week 26, more than 80% of participants in the elinzanetant arm achieved at least a 50% reduction in VMS frequency, including those who switched from placebo after week 12.
The treatment also led to statistically significant improvements in sleep disturbance and menopause-related quality of life.
Secondary endpoints were met, including a reduction in VMS frequency as early as week 1.

OASIS-34:

Elinzanetant demonstrated a statistically significant reduction in moderate to severe VMS frequency by week 12, sustained over 52 weeks.
The most commonly reported adverse events were headache, fatigue, and somnolence.

“I welcome expanded therapeutic options that address the diverse needs and preferences of women going through menopause," Paula Briggs, MBChB, a consultant gynecologist in sexual and reproductive health in Liverpool Women’s NHS Foundation Trust and immediate past chair of the British Menopause Society, said in a press release. "Physicians now have a new hormone-free treatment option that offers an alternative for tailoring treatment plans, helping women manage their symptoms and potentially enhance their overall quality of life during this important transition.”1

Bayer reported that regulatory submissions for elinzanetant are underway in the US, European Union, and additional markets.1

References:

Bayer receives first approval worldwide for Lynkuet™ (elinzanetant) in the UK as treatment of moderate to severe vasomotor symptoms associated with menopause. News release. Bayer. July 10, 2025. Accessed July 11, 2025. https://www.bayer.com/media/en-us/bayer-receives-first-approval-worldwide-for-lynkuet-elinzanetant-in-the-uk-as-treatment-of-moderate-to-severe-vasomotor-symptoms-associated-with-menopause/
Halsey G. Elinzanetant Update: FDA Accepts Bayer NDA, Sets July 2025 PDUFA Date. Patient Care Online. October 11, 2024. https://www.patientcareonline.com/view/elinzanetant-update-fda-accepts-bayer-nda-sets-july-2025-pdufa-date
Halsey G. Elinzanetant meets safety, efficacy endpoints in phase 3 studies of menopausal VMS. Patient Care Online. January 9, 2024. https://www.patientcareonline.com/view/elinzanetant-meets-safety-efficacy-endpoints-in-phase-3-studies-of-menopausal-vms
Jennings S. Topline phase 3 data released for elinzanetant efficacy for moderate-to-severe VMS. Patient Care Online. March 19, 2025. https://www.patientcareonline.com/view/topline-phase-3-data-released-for-elinzanetant-efficacy-for-moderate-to-severe-vms