Bayer has received the first global approval for elinzanetant, marketed as Lynkuet, for treating moderate to severe vasomotor symptoms (hot flashes) associated with menopause. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorized the hormone-free treatment, marking a significant milestone for women’s health therapeutics.
Elinzanetant is the first dual neurokinin (NK)-targeted therapy, acting as both NK-1 and NK-3 receptor antagonist. The approval is based on results from three pivotal Phase III trials in the OASIS clinical development program, where the drug demonstrated significant reductions in frequency and severity of moderate to severe vasomotor symptoms.
“This first approval worldwide marks a significant milestone for our hormone-free treatment elinzanetant to manage some of the most disruptive menopausal symptoms,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization at Bayer. “It highlights Bayer’s longstanding commitment to advance women’s health.”
The approval addresses a substantial unmet need, as up to 80% of women experience hot flashes during menopause transition, yet almost two-thirds remain untreated. Over one-third of menopausal women report severe symptoms that can last 10 years or more after their last menstrual period.
In the OASIS-1 and OASIS-2 studies, elinzanetant significantly reduced mean frequency and severity of moderate to severe vasomotor symptoms compared to placebo at weeks 4 and 12. Over 80% of participants achieved at least a 50% reduction in symptom frequency by week 26. The trials also showed statistically significant improvements in sleep disturbances and menopause-related quality of life.
OASIS-3 reinforced these findings, demonstrating sustained benefit and safety profile over 52 weeks. The most frequently reported adverse events versus placebo were headache, fatigue, and drowsiness.
“Menopausal symptoms, such as hot flashes, can have a profound impact on the quality of life for women,” said Dr. Paula Briggs, Consultant Gynaecologist and Immediate Past Chair of the British Menopause Society. “I welcome expanded therapeutic options that address the diverse needs and preferences of women going through menopause.”
The drug works by targeting hypothalamic neurons that express NK-1 and NK-3 receptors. Declining estrogen activity leads to hyperactivity of these neurons and dysregulation of the thermoregulatory center, resulting in vasomotor symptoms. Elinzanetant is administered orally once daily at a 120 mg dose.
Based on positive Phase III results, Bayer has submitted marketing authorization applications in the United States, European Union, and other global markets. The approvals could provide women with a new hormone-free alternative for managing menopausal symptoms.
By 2030, the global population of women experiencing menopause is projected to reach 1.2 billion, with 47 million women entering this phase annually. The UK approval represents the first step in making this treatment available to women worldwide who seek alternatives to hormone therapy for managing disruptive menopausal symptoms.
