Bayer gets UK nod for Lynkuet for moderate to severe vasomotor symptoms associated with menopause
Berlin: Bayer has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA, regulatory authority in the UK) for the use of elinzanetant, the first dual neurokinin NK-targeted therapy (NK-1 and NK-3 receptor antagonist) under the brand name Lynkuet (Lynkuet in UK) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause in the United Kingdom.
“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 and Member of the Pharmaceuticals Leadership Team at Bayer. “It highlights Bayer’s longstanding commitment to advance women’s health, and we are looking forward to bringing this option to many more women around the world.”
“Menopausal symptoms, such as hot flashes, can have a profound impact on the quality of life for women. They are not just physical discomforts; they can significantly disrupt daily activities, sleep and emotional well-being,” said Dr Paula Briggs, Consultant Gynaecologist in Sexual and Reproductive Health in Liverpool Women’s NHS Foundation Trust, 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. 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.”
The marketing authorization in the UK is the first approval worldwide and based on positive results from the Phase III studies OASIS-1, -2 and -3 evaluating the efficacy and safety profile of elinzanetant. Elinzanetant met all primary endpoints in all three studies and demonstrated a favorable safety profile.
In OASIS-1 and -2, elinzanetant significantly reduced mean frequency and severity of moderate to severe VMS associated with menopause compared to placebo at weeks 4 and 12. Efficacy was maintained with over 80% of participants in the elinzanetant group achieving at least a 50% reduction in VMS frequency by week 26, including those who switched from placebo to elinzanetant after week 12. Both trials also achieved all three key secondary endpoints showing a statistically significant mean reduction in the frequency of VMS from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo.
In OASIS-3, elinzanetant demonstrated a statistically significant mean reduction in the frequency of moderate to severe VMS from baseline to week 12 compared to placebo. The VMS reductions were maintained throughout the study duration. OASIS-3 reinforced the findings from OASIS-1 and -2, reporting a sustained benefit and safety profile over 52 weeks with the most frequently reported adverse with elinzanetant versus placebo being headache, fatigue and somnolence (also known as drowsiness).
Based on the positive results from the Phase III clinical development program, submissions for marketing authorizations for elinzanetant are also ongoing in the US, the EU and other markets around the world.
Elinzanetant is the first dual neurokinin (NK)-targeted therapy, (NK-1 and NK- 3 receptor antagonist), globally developed for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or endocrine therapy (ET) for breast cancer, administered orally once daily. Increasing evidence indicates that hypothalamic neurons, expressing both NK-1 and NK-3 receptors and their ligands, called kisspeptin, neurokinin B, and dynorphin (KNDy) neurons play a role in thermoregulation. Declining estrogenic activity due to natural menopause or ET leads to hyperactivity of KNDy neurons and dysregulation of the thermoregulatory center, resulting in VMS. NK-1 receptors may also have a role in the cooling response through sweating and peripheral vasodilatation as well as on sleep disturbance.
The compound has been authorized under the brand name Lynkuet in the UK in July 2025. It is under regulatory review in the Unites States, countries of the European Union and other markets around the world.
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