U.S. Approves Bayer’s Lynkuet™ for Menopause Vasomotor Symptom Relief

Bayer has received approval from the U.S. Food and Drug Administration (FDA) for its new menopause treatment, Lynkuet. This medicine, also known as elinzanetant, is the first dual neurokinin targeted therapy designed to relieve moderate to severe vasomotor symptoms (VMS), commonly recognized as hot flashes.

FDA Approval Marks a Milestone in Women’s Health

The FDA’s approval was announced on October 24, 2025. Lynkuet works by targeting neurokinin 1 (NK1) and neurokinin 3 (NK3) receptors, which play a critical role in managing the body’s thermoregulation. This innovative approach allows the treatment to modulate neuronal activity, thus providing relief from hot flashes.

Clinical Trials and Efficacy Data

This groundbreaking approval is backed by results from three Phase III clinical studies: OASIS 1, OASIS 2, and OASIS 3. These trials involved over 1,400 women and assessed the safety and efficacy of elinzanetant over several weeks.

• OASIS 1 and OASIS 2 involved 796 menopausal women and focused on changes in frequency and severity of VMS.
• OASIS 3 evaluated long-term safety in 627 women over a 52-week period.

According to JoAnn Pinkerton, M.D., a leading investigator, the findings emphasize the significant impact that hot flashes can have on daily life. Her insights underline the critical need for effective treatment options.

Expanded Treatment Options for Menopausal Women

Christine Roth, Executive Vice President at Bayer, highlighted that Lynkuet represents a significant advancement in menopause care. This hormone-free treatment expands available options for women experiencing VMS, addressing the increasing demand for personalized healthcare solutions.

Claire Gill, President of the National Menopause Foundation, affirmed that this approval provides women with more choices in managing their menopause symptoms. Lynkuet will become available at U.S. pharmacies starting November 2025.

Understanding Vasomotor Symptoms

Vasomotor symptoms like hot flashes are prevalent among menopausal women and can significantly disrupt daily activities. In 2030, the global population of women experiencing menopause is expected to reach 1.2 billion, with 47 million entering this phase each year. Managing these symptoms is vital for enhancing quality of life and maintaining functional ability during menopause.

Bayer’s Commitment to Women’s Health

Bayer continues to lead initiatives in women’s healthcare, developing innovative therapies to address unmet medical needs across the globe. As part of its sustainability strategy, Bayer aims to improve access to family planning and healthcare solutions for millions of women worldwide.

With Lynkuet, Bayer reaffirms its dedication to improving women’s healthcare and empowering women to take charge of their health.