Bayer has achieved a breakthrough in women’s health with the first global approval of elinzanetant, marketed as Lynkuet, a hormone-free medication developed to treat moderate to severe vasomotor symptoms—commonly experienced as hot flashes—during menopause.
This approval by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) represents a major advancement in managing menopausal health without relying on hormonal therapy.
Unlike traditional treatments, Lynkuet targets the neurological pathways responsible for regulating body temperature. Specifically, it acts as a dual neurokinin-1 (NK-1) and neurokinin-3 (NK-3) receptor antagonist, helping stabilize overactive brain activity that arises from decreasing estrogen levels.
This innovation provides a non-hormonal, once-daily oral option for women whose symptoms significantly disrupt sleep, work, and everyday comfort.
The decision by the MHRA is backed by strong evidence from Bayer’s OASIS clinical program, which included three large Phase III trials. Results from OASIS-1 and OASIS-2 showed that patients taking Lynkuet experienced significant reductions in the frequency and severity of hot flashes as early as four weeks, with sustained improvement through week 12 and beyond.
By week 26, more than 80% of participants had at least a 50% decrease in symptom frequency. Additionally, patients reported fewer sleep disturbances and better quality of life.
The long-term OASIS-3 trial confirmed the drug’s safety and continued effectiveness over a 52-week period. Common side effects included headache, fatigue, and drowsiness, but these were generally mild and manageable.
Menopausal vasomotor symptoms affect up to 80% of women, with more than a third experiencing severe symptoms that can persist for a decade or more. Yet, many avoid hormone replacement therapy due to health concerns, leaving a significant portion untreated or underserved.
“With millions of women entering menopause every year, there is a critical need for diverse, safe, and effective treatments,” said Dr. Paula Briggs, Consultant Gynaecologist and former Chair of the British Menopause Society. “This approval opens the door to a new era of symptom relief without hormones.”
Bayer has submitted Lynkuet for review in the United States, European Union, and other global markets, and its widespread adoption could offer new hope to a growing global population. By 2030, an estimated 1.2 billion women will be living with menopause-related symptoms, with 47 million entering the transition each year.
As the first medication of its kind to receive global regulatory approval, Lynkuet stands as a pivotal step forward in women’s health, offering a scientifically validated, hormone-free option to help women take control of their bodies and well-being during a challenging life stage.
